Trial | Phase | Enrollment | Study Type | Start Date | Status |
A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study) [NCT03649711] | Phase 3 | 76 participants (Actual) | Interventional | 2018-11-01 | Completed |
A 30 Day International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for PCI. [NCT01347580] | Phase 4 | 1,875 participants (Actual) | Interventional | 2011-09-30 | Completed |
Efficacy and Safety of Sequential Monotherapy of Ticagrelor and Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention With Acute Coronary Syndrome [NCT04937699] | Phase 4 | 2,690 participants (Anticipated) | Interventional | 2023-03-28 | Recruiting |
A Phase 2B, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversing Ticagrelor in Subjects Aged 50 to 80 Years Old [NCT04122170] | Phase 2 | 205 participants (Actual) | Interventional | 2019-09-24 | Completed |
A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of Oral AZD6140 After Single Dose in Healthy Japanese Male Volunteers [NCT01588626] | Phase 1 | 12 participants (Actual) | Interventional | 2012-05-31 | Completed |
Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS [NCT03775746] | Phase 4 | 150 participants (Anticipated) | Interventional | 2019-01-08 | Recruiting |
A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients With Sickle Cell Disease (HESTIA3) [NCT03615924] | Phase 3 | 193 participants (Actual) | Interventional | 2018-09-26 | Terminated(stopped due to Recommendation from an independent data monitoring committee (DMC) and accepted by AstraZeneca.) |
A Phase 2A, Randomized, Double-blind, Placebo-controlled, Single Dose, Sequential Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 With Ticagrelor Pretreatment in Older and Elderly Subjects and With High-D [NCT03928353] | Phase 2 | 23 participants (Actual) | Interventional | 2019-04-16 | Completed |
A Randomized, Single Center Trial to Assess the Endothelial Function With Ticagrelor Monotherapy Compared to Aspirin Monotherapy in Patients With History of Acute Coronary Syndrome [NCT03881943] | Phase 4 | 200 participants (Actual) | Interventional | 2017-01-31 | Completed |
Comparison of TIcagrelor and Clopidogrel in Patients With Coronary Artery diseaSe and Type 2 Diabetes Mellitus (TICS-DM): a Randomized Pharmacodynamic Study [NCT02457130] | Phase 4 | 30 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
A Sequential, Open Label Study to Compare the Pharmacokinetics, Safety and Tolerability of Ticagrelor and Venlafaxine Given Concomitantly in Healthy Subjects Aged 18 to 45 Years [NCT01350921] | Phase 1 | 22 participants (Actual) | Interventional | 2011-05-31 | Completed |
Reducing Micro Vascular Dysfunction In Revascularized ST-elevation Myocardial Infarction Patients by Off-target Properties of Ticagrelor [NCT02422888] | Phase 4 | 110 participants (Actual) | Interventional | 2015-05-31 | Active, not recruiting |
Ticagrelor in Comparison to Prasugrel for Inhibition of Platelet Reactivity, in Patients With Acute Coronary Syndrome (ACS) Presenting Resistance to the Usual Clopidogrel Dose After PCI [NCT01360437] | Phase 3 | 44 participants (Actual) | Interventional | 2011-05-31 | Completed |
Impact of Genetic Variation in CES1 on Antiplatelet Therapy [NCT03161678] | Phase 4 | 89 participants (Actual) | Interventional | 2017-08-22 | Completed |
Registry of Patients Admitted by Acute Coronary Syndrome to University Hospital of Vigo [NCT03664388] | | 8,000 participants (Anticipated) | Observational | 2016-02-01 | Recruiting |
Comparison of the Effects of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation in Patients With Prior Non-ST-segment Acute Coronary Syndrome [NCT02379676] | Phase 4 | 38 participants (Anticipated) | Interventional | 2015-01-31 | Recruiting |
Pharmacodynamic Comparison of Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function Genotype: a Validation Study in Patients With Stable Coronary Artery Disease [NCT03489863] | Phase 4 | 14 participants (Actual) | Interventional | 2018-05-30 | Completed |
The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease [NCT03577652] | | 108 participants (Actual) | Interventional | 2017-07-10 | Completed |
Switching From Ticagrelor to Prasugrel in Patients With Acute Coronary Syndrome-a Stepped Wedge Cluster Randomized Evaluation in the SWEDEHEART-registry [NCT05183178] | Phase 4 | 16,000 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
[NCT02037412] | Phase 4 | 148 participants (Actual) | Interventional | 2014-01-31 | Terminated(stopped due to The patient registration was not successful.) |
Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in Patients With Non ST Elevation Acute Coronary Syndromes [NCT02071966] | Phase 4 | 55 participants (Anticipated) | Interventional | 2012-11-30 | Terminated(stopped due to slow enrollment) |
The Effect of Ticagrelor and Apixaban With or Without Acetylsalicylic Acid on Markers of Coagulation Activation at the Site of Thrombus Formation in Vivo in Healthy Male Subjects and in an ex Vivo Perfusion Chamber Model at High and Low Shear Rate [NCT02080858] | Phase 1 | 40 participants (Actual) | Interventional | 2014-05-31 | Completed |
The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid (ASA) on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man [NCT02120092] | Phase 2 | 89 participants (Actual) | Interventional | 2010-10-31 | Completed |
Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug [NCT05418556] | Phase 4 | 3,944 participants (Anticipated) | Interventional | 2022-10-21 | Recruiting |
Study of Clopidogrel and Ticagrelor Anti-Platelet Treatment Using an Individualized Strategy Based on Genotyping in Chinese ACS Patients [NCT02048228] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2014-10-31 | Not yet recruiting |
Optimal Dose of Ticagrelor(90 mg qd)and Double Standard-dose Clopidogrel on Platelet Aggregation in Clopidogrel Resistance's Patients With Coronary Heart Disease [NCT03614832] | Phase 4 | 100 participants (Anticipated) | Interventional | 2018-05-01 | Recruiting |
The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction [NCT05210595] | Phase 4 | 120 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
[NCT02032290] | Phase 4 | 88 participants (Anticipated) | Interventional | 2014-02-28 | Not yet recruiting |
The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin [NCT03869268] | Phase 4 | 72 participants (Actual) | Interventional | 2019-04-24 | Completed |
Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG) [NCT01373411] | Phase 4 | 70 participants (Actual) | Interventional | 2011-09-30 | Completed |
a Single Centre Open Pilot Study to Explore if the Efficacy of PLAtelet Aggregation Inhibition by Ticagrelor Mediated P2Y12 Blockade Dependent Upon Endogenous Endothelial Nitric OXide? [NCT02169596] | Phase 4 | 74 participants (Actual) | Interventional | 2015-06-30 | Completed |
Ticagrelol Versus Aspirin in Ischemic Stroke [NCT03884530] | Phase 3 | 169 participants (Actual) | Interventional | 2019-05-01 | Completed |
Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II [NCT04078737] | Phase 3 | 6,412 participants (Actual) | Interventional | 2019-09-23 | Completed |
An Open-label Study Evaluating the Acute Efficacy of Treatment With Ticagrelor Versus Clopidogrel on Myocardial Tissue-level Perfusion Assessed by TMPFC and MRI in Patients With High-risk NSTE-ACS Undergoing Early PCI(EARLY-MYO II) [NCT02201667] | Phase 4 | 444 participants (Anticipated) | Interventional | 2014-08-31 | Not yet recruiting |
Peripheral Endothelial Function Assessment of Patients on Ticagrelor vs. Clopidogrel Who Have Undergone Percutaneous Coronary Intervention - a Randomised, Crossover Study. [NCT02469740] | Phase 4 | 61 participants (Actual) | Interventional | 2015-07-31 | Completed |
Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome - Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5 [NCT01944800] | Phase 4 | 4,018 participants (Actual) | Interventional | 2013-09-15 | Completed |
The Effects of Crushed Ticagrelor Versus Eptifibatide Bolus +Clopidogrel in Troponin-Negative ACS Patients Undergoing Coronary Intervention [NCT02925923] | Phase 2 | 100 participants (Actual) | Interventional | 2016-11-01 | Completed |
A comParison on Platelet Resistance With Ticagrelor or Standard-Dose Clopidogrel Study Among SeVerE Chronic Kidney Disease/ End-Stage-Renal-Disease Patients With Recent Acute Coronary Syndrome. [NCT02459288] | Phase 4 | 80 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
"High on Treatment Platelet Reactivity in the Intensive Care Unit" [NCT02285751] | Phase 2 | 200 participants (Anticipated) | Interventional | 2012-11-30 | Recruiting |
Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients [NCT02323971] | | 80 participants (Anticipated) | Observational | 2014-12-31 | Recruiting |
A Single Centre, Cross-over, Single Dose, Two Period, Randomized, Open Label Bioequivalence Study of Anplag® 90mg (Ticagrelor) Tablet With Brilinta® 90 mg (Ticagrelor) Tablet in Healthy Adult Male Pakistani Subjects Under Fasting Condition [NCT04941196] | Phase 1 | 30 participants (Actual) | Interventional | 2020-10-16 | Completed |
[NCT02032303] | Phase 4 | 88 participants (Anticipated) | Interventional | 2014-02-28 | Not yet recruiting |
Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement. [NCT02866175] | Phase 3 | 1,506 participants (Actual) | Interventional | 2017-02-24 | Completed |
[NCT02817789] | Phase 3 | 50 participants (Actual) | Interventional | 2016-05-09 | Completed |
Study of Two Regimens of TicagrElor Compared to Clopidogrel in Patients Undergoing ELective Percutaneous Coronary Intervention [NCT02327624] | Phase 4 | 180 participants (Actual) | Interventional | 2015-06-30 | Completed |
Effects of P2Y12 Receptor Inhibitors on Central and Peripheral Chemoreceptors' Sensitivity [NCT05080478] | | 50 participants (Anticipated) | Observational | 2018-11-01 | Recruiting |
A Single Center Phase II Assessor-Blinded RaNdomised Active Controlled Parallel-Group Trial to COmpare Ticagrelor Versus Clopidogrel on the REduction of ArteriaL STiffness and Wave Reflections in Patients With CoronarY Artery Disease. [NCT02071212] | Phase 2 | 120 participants (Actual) | Interventional | 2014-02-28 | Completed |
Comparison of Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI Undergoing PPCI Evaluated by SPECT [NCT02233790] | Phase 4 | 600 participants (Anticipated) | Interventional | 2014-12-31 | Not yet recruiting |
The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry [NCT02264912] | | 2,016 participants (Actual) | Observational [Patient Registry] | 2008-07-31 | Completed |
Real-TICA Real Life Long-term Adherence to Ticagrelor After PCI for Acute Coronary Syndromes. Evaluation of Antiplatelet Therapy After 12 Months in Patients Undergoing PCI and Treated With Ticagrelor During the Acute Phase of an ACS. [NCT02265068] | | 700 participants (Actual) | Observational | 2014-08-31 | Completed |
Ticagrelor Plus Aspirin vs Clopidogrel Plus Aspirin in Mild Non-cardioembolic Ischemic Stroke: A Randomized, Active Comparator Arm, Outcome Assessor Blind, Controlled, Feasibility Study [NCT04738097] | Phase 3 | 90 participants (Actual) | Interventional | 2021-08-08 | Completed |
Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI) [NCT04695106] | Phase 4 | 2,230 participants (Anticipated) | Interventional | 2021-10-25 | Recruiting |
Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve [NCT02108808] | Phase 4 | 76 participants (Actual) | Interventional | 2014-04-30 | Completed |
Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt [NCT02118870] | Phase 4 | 1,500 participants (Actual) | Interventional | 2014-06-10 | Completed |
Comparison of The Influence of Ticagrelor And Clopidogrel on Inflammatory Biomarkers And Vascular Endothelial Function For Patients With ST-Segment Elevation Myocardial Infarction Receiving Emergency Percutaneous Coronary Intervention [NCT02123004] | Phase 4 | 350 participants (Anticipated) | Interventional | 2014-04-30 | Not yet recruiting |
A Randomized, Open-Label, Parallel, Multi-Center, Phase IV Study to Assess the Effect of Ticagrelor vs Clopidogrel on Adenosine-Induced Myocardial Blood Flow in Peripheral Artery Disease (PAD)Patients [NCT02121288] | Phase 4 | 0 participants (Actual) | Interventional | 2014-12-31 | Withdrawn |
PANDDA Study: Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients [NCT02302508] | Phase 4 | 0 participants (Actual) | Interventional | 2019-09-01 | Withdrawn(stopped due to Funding) |
Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After Undergoing Percutaneous Coronary Intervention:The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) - 2 Study [NCT04483583] | Phase 4 | 80 participants (Anticipated) | Interventional | 2020-12-08 | Recruiting |
Combined Effect of Diabetes and cyp2c19 Polymorphism on Clopidogrel VS Ticagrelor Antiplatelet Activity in Patients of Anterior ST Elevation Myocardial Infarction Undergoing Primary PCI [NCT03613857] | | 1,022 participants (Actual) | Observational [Patient Registry] | 2017-04-15 | Completed |
Platelet Reactivity in Patients With End Stage Renal Disease Receiving Clopidogrel Compared With Ticagrelor [NCT02163954] | Phase 3 | 16 participants (Actual) | Interventional | 2013-01-31 | Completed |
Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients With Chronic Obstructive Pulmonary Disease [NCT03487406] | Phase 2 | 120 participants (Actual) | Interventional | 2015-09-30 | Completed |
A Randomized Non-inferiority Study of Low-dose and Standard-dose Ticagrelor After Intervention for Acute Coronary Syndrome [NCT04255602] | Phase 4 | 2,120 participants (Anticipated) | Interventional | 2020-02-19 | Recruiting |
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetic Profiles and Safety/Tolerability of CKD-357 in Healthy Volunteers [NCT03671941] | Phase 1 | 31 participants (Actual) | Interventional | 2018-05-25 | Completed |
Stent-Assisted Coiling Followed by Ticagrelor Monotherapy Instead of Dual Antiplatelet Therapy in Endovascular Treatment of Unruptured Intracranial Aneurysm (SAC-TIDE) ---a Pilot Study [NCT06015477] | | 180 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
A Randomized, Open Label, Pilot Study to Assess the Pharmacodynamics Using Vefiynow and VASP Assay; and Pharmacokinetics of Ticagrelor vs Clopidogrel in Patients Undergoing PCI With History of Fibrinolysis in 24-48 Hours [NCT02048085] | Phase 4 | 0 participants (Actual) | Interventional | 2014-01-02 | Withdrawn(stopped due to unable to get study up and enrolling) |
CYP2C19 Genotype-GUided Dual Antiplatelet theRapy in pAtieNts Treated With New Generation Drug Eluting stEnts (the GUARANTEE Study) [NCT03783351] | | 4,009 participants (Anticipated) | Interventional | 2019-05-27 | Recruiting |
ST-segment Elevation Myocardial infArction Treated With a Polymer-free Sirolimus-based nanocarrieR Eluting Stent and a P2Y12 Inhibitor-based Aspirin-free Single Antiplatelet Strategy Versus Conventional Dual AntiPlatelet Therapy [NCT05785897] | | 350 participants (Anticipated) | Interventional | 2024-06-01 | Not yet recruiting |
A Prospective Randomized Double Blind Study to Evaluate the Effect of Ticagrelor on Endothelial Function [NCT02261922] | Phase 4 | 20 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial [NCT02094963] | Phase 4 | 800 participants (Actual) | Interventional | 2014-07-05 | Completed |
Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting: The ALPHEUS Study [NCT02617290] | Phase 3 | 1,900 participants (Actual) | Interventional | 2017-01-09 | Completed |
Comparison of 1-month Versus 12-month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents Guided by Either Intravascular Ultrasound or Angiography in Patients With Acute Coronary Syndrome: The Prospective, Multicenter, Randomized, Placebo- [NCT03971500] | | 3,710 participants (Actual) | Interventional | 2019-08-20 | Active, not recruiting |
A Randomized, Double-blind, Placebo Controlled, Crossover, Single Centre Phase I Study to Assess the Effect of Ticagrelor on Adenosine-induced Coronary Blood Flow Velocity in Healthy Male Subjects [NCT01226602] | Phase 1 | 39 participants (Actual) | Interventional | 2010-12-31 | Completed |
Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation [NCT02224066] | Phase 4 | 65 participants (Actual) | Interventional | 2016-01-31 | Completed |
Comparison of Analgesia With Fentanyl and Morphine on Platelet Inhibition After Pre-hospital Ticagrelor Administration in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [NCT02531165] | | 38 participants (Actual) | Interventional | 2015-09-30 | Completed |
High PlatElet Inhibition With TicAgrelor to Improve Left Ventricular RemodeLING in Patients With ST-segment ElevAtion Myocardial Infarction: the HEALING-AMI Trial. [NCT02224534] | Phase 4 | 326 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects [NCT04945616] | Phase 1 | 52 participants (Actual) | Interventional | 2021-07-13 | Completed |
Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina [NCT02284048] | Phase 4 | 140 participants (Anticipated) | Interventional | 2014-11-30 | Not yet recruiting |
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study [NCT04001894] | Phase 4 | 50 participants (Actual) | Interventional | 2019-07-02 | Completed |
Ticagrelor Versus Clopidogrel in Ischemic Stroke. a Randomized Double-blinded Controlled Trial [NCT05553613] | Phase 3 | 900 participants (Actual) | Interventional | 2022-10-01 | Completed |
Phase III, Randomized, International, Multicenter, Open Label, With Blinded Adjudication of Outcomes, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Ticagrelor Compared With Clopidogrel in Patients With Acute Coronary Syndrome With S [NCT02298088] | Phase 3 | 3,799 participants (Actual) | Interventional | 2015-08-31 | Completed |
Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly [NCT02317198] | Phase 4 | 1,011 participants (Actual) | Interventional | 2013-06-30 | Active, not recruiting |
High On-treatment Platelet Reactivity to Adenosine Diphosphate Identified by Multiple Platelet Function Assay Guide to Modify Anti-platelet Strategy in Patients Undergoing Percutaneous Coronary Intervention [NCT02699008] | | 477 participants (Actual) | Interventional | 2014-01-31 | Completed |
A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Tra [NCT03354429] | Phase 3 | 11,016 participants (Actual) | Interventional | 2018-01-22 | Completed |
Hunting for the Off-Target Properties of Ticagrelor on Endothelial Function and Other Circulating Biomarkers in Humans [NCT02587260] | Phase 4 | 54 participants (Actual) | Interventional | 2015-12-17 | Completed |
Incidence and Models of Ticagrelor Discontinuation in Patients With Acute Coronary Syndrome [NCT03129867] | | 480 participants (Actual) | Observational | 2017-01-01 | Completed |
Low Dose EPInephrine to Improve Platelet Reactivity in TICagrelor-treated Subjects: A Proof of Concept Study in Healthy Volunteers (EPITIC) [NCT03441412] | Phase 1 | 10 participants (Actual) | Interventional | 2018-02-28 | Completed |
A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Efficacy and Safety of Low Dose Ticagrelor Compared With Standard Dose Ticagrelor in Patients With Unstable Angina Pectoris After Drug Eluting Stent Implantation [NCT03620760] | Phase 4 | 2,036 participants (Anticipated) | Interventional | 2018-08-07 | Recruiting |
Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass: Prospective, Randomized Controlled Trial [NCT05166538] | Phase 4 | 204 participants (Anticipated) | Interventional | 2022-02-01 | Not yet recruiting |
Impact of Chronic Kidney Disease on the Pharmacodynamic and Pharmacokinetic Effects of Ticagrelor in Patients With Diabetes Mellitus and Coronary Artery Disease [NCT02539160] | Phase 4 | 101 participants (Actual) | Interventional | 2016-02-29 | Completed |
A Randomized, Pharmacodynamic Comparison of Low Dose Ticagrelor (60mg Bid) to Low Dose Prasugrel (5mg od) in Patients With Prior Myocardial Infarction [NCT03387826] | Phase 4 | 20 participants (Actual) | Interventional | 2018-01-11 | Completed |
Comparison Between Ticagrelor and Clopidogrel Effect on Endothelial, Platelet and Inflammation Parameters in Patients With Stable Coronary Artery Disease and Chronic Obstructive Pulmonary Disease Undergoing PCI [NCT02519608] | Phase 2 | 44 participants (Actual) | Interventional | 2015-09-30 | Completed |
TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome. [NCT03357874] | Phase 3 | 514 participants (Anticipated) | Interventional | 2018-10-28 | Recruiting |
Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study) [NCT02026219] | Phase 4 | 76 participants (Actual) | Interventional | 2013-10-31 | Completed |
Effects of Different Doses of Ticagrelor and Standard-dose Clopidogrel on Platelet Aggregation and Endothelial Function in Diabetic Patients With Stable Coronary Artery Disease [NCT02889549] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2016-08-31 | Recruiting |
Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI [NCT02888652] | | 1,500 participants (Actual) | Observational [Patient Registry] | 2015-09-30 | Completed |
COmparison of the Pharmacodynamics and Pharmacokinetics of Ticagrelor Versus Clopidogrel in Patients With Chronic Kidney Disease and Non-ST-Elevation Acute Coronary Syndromes(OPT-CKD Trial) [NCT02578537] | Phase 4 | 60 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen [NCT05373277] | Phase 1 | 10 participants (Anticipated) | Interventional | 2022-05-11 | Recruiting |
Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm [NCT02675205] | Phase 3 | 100 participants (Actual) | Interventional | 2015-12-31 | Completed |
Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting [NCT04091074] | Phase 1 | 26 participants (Anticipated) | Interventional | 2022-01-01 | Not yet recruiting |
A Prospective Randomized Controlled Clinical Trial of Comparing ticagreLor Versus clopidogrEl on mIcrocirculation in Patients With Acute cOronary Syndrome Study [NCT02618733] | | 120 participants (Actual) | Interventional | 2014-12-31 | Completed |
A Randomised, Double-Blind, Outpatient, Crossover Study of the Anti-platelet Effects of Ticagrelor Compared With Clopidogrel in Patients With Stable Coronary Artery Disease Previously Identified as Clopidogrel Non-responders or Responders [RESPOND] [NCT00642811] | Phase 2 | 98 participants (Actual) | Interventional | 2008-05-31 | Completed |
An Open-label, Randomised, 3-period, 3-treatment, Crossover, Single-centre, Single-dose, Bioavailability Study With Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunte [NCT01887626] | Phase 1 | 36 participants (Actual) | Interventional | 2013-07-31 | Completed |
Ticagrelor Versus Clopidogrel for Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction: A Retrospective Study Based on the Angiography-derived Index of Microcirculatory Resistance [NCT05978726] | | 325 participants (Actual) | Observational | 2017-07-01 | Completed |
Chinese People's Liberation Army General Hospital [NCT02798874] | | 240 participants (Anticipated) | Interventional | 2016-05-31 | Enrolling by invitation |
Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention: A Magnetic Resonance Imaging Study (TIGER Study) [NCT02792712] | Phase 4 | 200 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 (Bentracimab) With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteer [NCT05162131] | Phase 1 | 40 participants (Anticipated) | Interventional | 2021-12-25 | Recruiting |
A Randomized, Open-label Study to Compare the Platelet Inhibition With VerifyNow Assay of Ticagrelor Versus Clopidogrel in Troponin Negative Acute Coronary Syndrome Subjects Undergoing Ad Hoc Percutaneous Coronary Intervention [NCT01603082] | Phase 4 | 343 participants (Actual) | Interventional | 2012-07-31 | Completed |
TIcagrelor in Rotational Atherectomy to Reduce TROPonin Enhancement: the TIRATROP Study, a Randomized Controlled Trial [NCT02505399] | Phase 4 | 180 participants (Actual) | Interventional | 2015-11-30 | Completed |
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial [NCT05283356] | Phase 4 | 1,206 participants (Anticipated) | Interventional | 2022-01-21 | Recruiting |
Aspirin Plus Ticagrelor for 1 Month Followed by 5 Months Ticagrelor Monotherapy Versus Aspirin Plus Ticagrelor for 12 Months in Acute Coronary Syndrome Patients With Drug-coated Balloon: a Multicentre, Randomized, Non-inferiority Trial [NCT04971356] | | 1,948 participants (Actual) | Interventional | 2021-11-01 | Active, not recruiting |
Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects [NCT02086903] | Phase 3 | 12 participants (Actual) | Interventional | 2014-02-28 | Completed |
Dual Antiplatelet Therapy to Inhibit Coronary Atherosclerosis and Myocardial Injury in Patients With Necrotic High-Risk Coronary Plaque Disease [NCT02110303] | Phase 2/Phase 3 | 220 participants (Actual) | Interventional | 2015-03-31 | Completed |
Half-dose Ticagrelor Overcomes High-dose Clopidogrel in Acute Coronary Syndrome Patients With High On-Clopidogrel Platelet Reactivity [NCT03062462] | Phase 2/Phase 3 | 80 participants (Anticipated) | Interventional | 2017-02-10 | Recruiting |
Does Ticagrelor Inhibit Growth of Small Abdominal Aortic Aneurysms? A Randomised Controlled Trial (TicAAA) [NCT02070653] | Phase 2 | 145 participants (Actual) | Interventional | 2014-03-31 | Completed |
A Randomised, Open-label, Parallel Group, Multi-center Study Using OCT to Comparing the Efficacy and Safety of Ticagrelor With Clopidogrel in the Prevention of Subclinical Thrombus in Patients After Drug-eluting Stent Implantation [NCT02140801] | Phase 4 | 352 participants (Actual) | Interventional | 2014-05-01 | Completed |
A Multicenter Trial to Assess the MIcrovascular Integrity and Left Ventricular Function Recovery After Clopidogrel or TicagrelOr Administration, in Patients With STEMI Treated With Thrombolysis - The 'MIRTOS' Study [NCT02429271] | Phase 3 | 336 participants (Actual) | Interventional | 2015-08-31 | Completed |
Safety and Efficacy of Ticagrelor Single Antiplatelet Therapy in Patients With High Risk of Bleeding After Drug-coated Balloons for Coronary Small Vessel Disease: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation, Single-center Study [NCT06088433] | Phase 4 | 292 participants (Anticipated) | Interventional | 2023-11-15 | Not yet recruiting |
A Randomized Controlled Trial of Patients Undergoing Percutaneous Coronary Intervention Who Receive Ticagrelor and Fentanyl [NCT03476369] | Phase 4 | 80 participants (Anticipated) | Interventional | 2018-04-18 | Recruiting |
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers [NCT00733265] | Phase 1 | 24 participants (Anticipated) | Interventional | 2007-02-28 | Completed |
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia [NCT02735707] | Phase 3 | 10,000 participants (Anticipated) | Interventional | 2016-04-11 | Recruiting |
A Randomized, Open-label, Active-controlled, Parallel-group Study to Investigate the Platelet Inhibition of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease and Type 2 Diabetes Mellitus After Recent Elective Percutaneous Coron [NCT02748330] | Phase 4 | 40 participants (Actual) | Interventional | 2016-06-30 | Completed |
Post-operative Treatment of Diabetic Peripheral Arterial Disease Guided by Platelet Reactivity Unit [NCT02762864] | | 200 participants (Anticipated) | Interventional | 2016-05-31 | Enrolling by invitation |
Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction [NCT02808767] | Phase 4 | 1,226 participants (Actual) | Interventional | 2013-01-31 | Completed |
30-d Rand, Eval-blind, Controlled, Multi-centre, Parallel, ph III Study to Evaluate Effect of a Low Maint Dose Ticagrelor Regimen vs Standard Dose Clopidogrel on Coronary Flow Reserve in DM Patients With Impaired Microvascular Function Without Prior MI or [NCT04069234] | Phase 3 | 0 participants (Actual) | Interventional | 2019-09-15 | Withdrawn(stopped due to Sponsor decided to stop the study due to commercial reasons.) |
Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy [NCT06013020] | Phase 4 | 374 participants (Anticipated) | Interventional | 2023-08-28 | Recruiting |
Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients: Define CCS Study, a Prospective Randomized Crossover Clinical Trial. [NCT05116995] | Phase 4 | 30 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting |
DEVELOPMENT OF PROGNOSTIC PLATELET RNA BIOMARKERS TO TAILOR ANTIPLATELET THERAPY [NCT05278637] | Early Phase 1 | 135 participants (Actual) | Interventional | 2013-11-01 | Completed |
Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus [NCT01531114] | Phase 3 | 50 participants (Actual) | Interventional | 2013-05-31 | Completed |
The Effect of Ticagrelor on 15-Epi-Lipoxin A4 and Inflammation [NCT02626169] | Phase 4 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn(stopped due to Pharmaceutical company sponsor withdrew support prior to enrollment of subjects.) |
The Effect of Ticagrelor on the Inflammatory Response to Human Endotoxemia [NCT02612480] | | 40 participants (Actual) | Interventional | 2015-10-31 | Completed |
Pharmacokinetic/Pharmacodynamic Effects of add-on Antiplatelet Therapy With Parenteral Cangrelor as Compared to Standard Dual Antiplatelet Treatment in Patients With ST-elevation Myocardial Infarction Complicated by Out-of-hospital Cardiac Arrest and Trea [NCT03273075] | Phase 4 | 60 participants (Anticipated) | Interventional | 2017-09-30 | Recruiting |
Prevention of Cerebral Ischaemia in Stent Treatment for Carotid Artery Stenosis - A Randomised Multi-centre Phase II Trial Comparing Ticagrelor Versus Clopidogrel With Outcome Assessment on MRI (PRECISE-MRI) [NCT02677545] | Phase 2 | 210 participants (Actual) | Interventional | 2016-12-31 | Completed |
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myoca [NCT01225562] | Phase 3 | 21,379 participants (Actual) | Interventional | 2010-10-31 | Completed |
A Randomized, Pharmacodynamic Comparison of Low Dose Ticagrelor to Clopidogrel in Patients With Prior Myocardial Infarction [NCT02663713] | Phase 4 | 20 participants (Actual) | Interventional | 2017-01-31 | Completed |
Ticagrelor in Remote Ischemic Preconditioning Study [NCT04174261] | Phase 4 | 245 participants (Actual) | Interventional | 2017-01-29 | Completed |
Rapid P2Y12 Receptor Inhibition Attenuates Inflammatory Cell Infiltration in Thrombus Aspirated From the Infarct-related Artery in STEMI Patients: A Prospective Randomized Trial of Ticagrelor Versus Clopidogrel [NCT02639143] | Phase 4 | 50 participants (Actual) | Interventional | 2015-12-31 | Completed |
A Randomized Controlled sTudy of Low Dose vs Standard Dose of tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Diabetes Mellitus Patients [NCT04307511] | Phase 4 | 40 participants (Anticipated) | Interventional | 2020-04-20 | Recruiting |
SMart Angioplasty Research Team: Comparison Between P2Y12 Inhibitor MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary BiorEsorbable Scaffold II: (SMART-CHOICE II) Trial [NCT03119012] | Phase 4 | 1,520 participants (Anticipated) | Interventional | 2017-04-19 | Suspended(stopped due to cannot use bioabsorbable scaffold) |
Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Prospective, Randomized, Open-label, Blinded-endpoint Evaluation, [NCT04240834] | Phase 3 | 1,220 participants (Anticipated) | Interventional | 2020-02-29 | Not yet recruiting |
LOwer Maintenance Dose TICagrelor in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention [NCT04060914] | Phase 4 | 225 participants (Anticipated) | Interventional | 2019-08-30 | Not yet recruiting |
A Randomized Controlled Trial on the Switch From Ticagrelor to Clopidogrel in Acute Coronary Syndrome Patients After Percutaneous Coronary Intervention--OPTImal Management of Antithrombotic Agents: OPTIMA-5 [NCT04116931] | Phase 4 | 80 participants (Anticipated) | Interventional | 2020-06-22 | Recruiting |
A Randomized, Open-label, Pharmacodynamic and Pharmacokinetic Trial Assessing the Effect of Lowering Ticagrelor Maintenance Dose Early After Myocardial Infarction on Platelet Inhibition (ELECTRA Pilot Study). [NCT03251859] | Phase 3 | 52 participants (Actual) | Interventional | 2017-08-11 | Completed |
Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions: an Open-label, Multicenter, Randomized, Non-inferiority Trial [NCT05209412] | | 370 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
Single-center, Prospective, Controlled Study of the Safety and Efficacy of Aspirin and Clopidogrel in Ischemic Cardiovascular and Cerebrovascular Patients Complications With CAA [NCT04654026] | | 43 participants (Anticipated) | Observational | 2021-02-20 | Not yet recruiting |
One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients [NCT05997693] | Phase 3 | 700 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
The Effect of an Acute Dose of Ticagrelor or Clopidogrel and of Treatment for 14 Days on Ischemia-reperfusion Induced Endothelial Dysfunction of the Forearm Vasculature in Healthy Male Subjects. [NCT02580149] | Phase 4 | 24 participants (Actual) | Interventional | 2015-10-31 | Completed |
A Multi-centre Randomised, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of Ticagrelor Compared With Clopidogrel and Placebo With Aspirin as Background Therapy in Patients With Stable Coronary Artery Disea [NCT00528411] | Phase 2 | 123 participants (Actual) | Interventional | 2007-10-31 | Completed |
A Randomised, Double-blind, Two-way Crossover Study to Determine the Effects of Co-administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers [NCT00685906] | Phase 1 | 24 participants (Anticipated) | Interventional | 2008-04-30 | Completed |
Efficacy and Safety of Early Versus Late Loading Dose of Ticagrelol in Patients With ST Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [NCT04267224] | | 800 participants (Anticipated) | Observational | 2020-03-01 | Not yet recruiting |
Personalization of Long-Term Antiplatelet Therapy Using a Novel Combined Demographic/Pharmacogenomic Strategy - The RAPID EXTEND Randomized Study [NCT03729401] | Phase 4 | 390 participants (Anticipated) | Interventional | 2019-08-22 | Suspended(stopped due to Testing supplies unavailable.) |
Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial [NCT02601157] | Phase 4 | 2,173 participants (Actual) | Interventional | 2016-01-18 | Completed |
The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy) [NCT02767401] | Phase 4 | 200 participants (Actual) | Interventional | 2015-09-15 | Completed |
Platelet Sub-study of the TWILIGHT Trial [NCT04001374] | | 40 participants (Actual) | Observational | 2015-06-28 | Completed |
REACTIC-TAVI Trial: Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation. A Pilot Study. [NCT04331145] | Phase 4 | 40 participants (Actual) | Interventional | 2020-06-23 | Completed |
Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in ST-elevation Myocardial Infarction and Non-ST-elevation Myocardial Infarction Patients [NCT02602444] | | 73 participants (Actual) | Observational | 2015-10-31 | Completed |
Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy [NCT04766437] | Phase 2 | 75 participants (Actual) | Interventional | 2021-02-19 | Completed |
Effect of Pretreatment With Ticagrelor on Residual Thrombus After Percutaneous Coronary Intervention (PCI) in Patients Presenting With Acute Coronary Syndrome in Comparison With Delayed Treatment at the Time of PCI: an Optical Coherence Tomography Study [NCT01916902] | Phase 4 | 0 participants (Actual) | Interventional | 2014-02-28 | Withdrawn(stopped due to Despite a large number of patients screened, very few met eligibility guidelines.) |
The Safety and Efficacy of Ticagrelor for Coronary Stenting Post Thrombolysis (SETFAST) Trial. [NCT01930591] | Phase 3 | 140 participants (Actual) | Interventional | 2014-05-31 | Completed |
Plaque Erosion: A New in Vivo Diagnosis and Paradigm Shift in the Treatment of Patients With Acute Coronary Syndrome [NCT02041650] | Phase 4 | 250 participants (Anticipated) | Interventional | 2014-08-31 | Completed |
Reassessment of Anti-Platelet Therapy Using InDividualized Strategies - Modifying Acute CoroNary Syndrome Algorithms Based on Genetic and Demographic Evaluation: The RAPID-MANAGE Study [NCT02044146] | Phase 2/Phase 3 | 120 participants (Actual) | Interventional | 2014-09-30 | Completed |
OraL Crushed and dIspersed Ticagrelor 180mg Compared to Whole Tablets of eQUal Dose in STEMI Patients unDergoing Primary PCI: a Pharmacokinetic/Pharmacodynamic Study [NCT02046486] | Phase 4 | 20 participants (Anticipated) | Interventional | 2014-01-31 | Completed |
An Open-label, Randomized, Prospective Study Exploring Half Dose of Prasugrel and Ticagrelor in Platelet Response After Acute Coronary Syndromes [NCT02944123] | Phase 3 | 120 participants (Actual) | Interventional | 2016-09-30 | Completed |
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Effect of Atorvastatin Treatment for 14 Days in Combination With an Acute Dose of Ticagrelor on Ischemia Reperfusion Induced Endothelial Dysfunction of the Forearm Vasculat [NCT02910778] | Phase 4 | 32 participants (Actual) | Interventional | 2016-10-31 | Completed |
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inh [NCT00391872] | Phase 3 | 18,624 participants (Actual) | Interventional | 2006-10-31 | Completed |
A Single Dose, Open-label, One Sequence, 2-period, Crossover Study to Characterize the Pharmacokinetics and Pharmacodynamics of Ticagrelor and Prasugrel in Healthy Male Adult Subjects [NCT01876797] | Phase 1 | 12 participants (Actual) | Interventional | 2013-07-31 | Completed |
XANTHIPPE: Examining the Effect of Ticagrelor on Platelet Activation, Platelet-Leukocyte Aggregates, and Acute Lung Injury in Pneumonia [NCT01883869] | Phase 1 | 60 participants (Actual) | Interventional | 2013-06-30 | Completed |
ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study [NCT01894789] | Phase 2/Phase 3 | 36 participants (Actual) | Interventional | 2013-03-31 | Completed |
Comparison of Clopidogrel Versus Ticagrelor Therapy for Atherosclerotic Plaque Inflammation: Serial FDG PET/CT Imaging Study of Carotid Artery and Ascending Aorta [NCT01905566] | Phase 4 | 50 participants (Actual) | Interventional | 2013-09-30 | Completed |
A Randomized Controlled sTudy of Low Dose vs Standard tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Senior Patients [NCT04307485] | Phase 4 | 40 participants (Anticipated) | Interventional | 2020-03-10 | Recruiting |
3 Months Versus 12 Months Dual Antiplatelet Therapy After Second Generation Sirolimus Stent Implantation in ST-elevation Myocardial Infarction(BULK-STEMI) [NCT04570345] | Phase 4 | 1,002 participants (Anticipated) | Interventional | 2021-01-01 | Recruiting |
Randomized, Placebo-controlled, Single Blind, Trial to Determine the Safety and Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis [NCT02335099] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2014-12-31 | Completed |
Pharmacodynamic Assessment of Ticagrelor vs High Dose Clopidogrel in Patients With ST Elevation Myocardial Infarction Exhibiting High Platelet Reactivity Post Fibrinolysis [NCT01950416] | Phase 4 | 56 participants (Actual) | Interventional | 2013-03-31 | Completed |
Intensified Antiplatelet Therapy in Post-PCI Patients With High On-treatment Platelet Reactivity: the OPTIMA-2 Trial [NCT01955200] | Phase 4 | 1,724 participants (Actual) | Interventional | 2013-10-05 | Completed |
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease [NCT01957540] | Phase 4 | 22 participants (Actual) | Interventional | 2014-06-30 | Completed |
Platelet Reactivity After Ticagrelor Loading Dose Versus Clopidogrel Loading Dose and Reloading With Ticagrelor, in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention (PCI). [NCT01961856] | Phase 3 | 74 participants (Actual) | Interventional | 2013-09-30 | Completed |
Genotype Guided Versus Conventional Approach in Selection of Oral P2Y12 Receptor Blocker in Chinese Patients Suffering From Acute Coronary Syndrome [NCT01994941] | Phase 4 | 133 participants (Actual) | Interventional | 2013-08-31 | Completed |
The Effect of Ticagrelor on the Adenosine System [NCT01996735] | Phase 4 | 14 participants (Actual) | Interventional | 2013-04-30 | Completed |
[NCT02012140] | Phase 4 | 200 participants (Anticipated) | Interventional | 2014-01-31 | Not yet recruiting |
A Prospective, Multicenter, Randomized, Open-label Trial to Compare Efficacy and Safety of Clopidogrel vs Ticagrelor in Stabilized Patients With Acute Myocardial Infarction After Percutaneous Coronary Intervention; TicAgrelor Versus CLOpidogrel in Stabili [NCT02018055] | Phase 4 | 2,590 participants (Actual) | Interventional | 2014-02-14 | Completed |
Ticagrelor Versus Clopidogrel in Large Vessel Ischemic Stroke, a Randomized Controlled Trial [NCT06120725] | Phase 3 | 580 participants (Actual) | Interventional | 2021-09-01 | Completed |
Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock [NCT03551964] | Phase 4 | 550 participants (Anticipated) | Interventional | 2018-08-01 | Recruiting |
Pragmatic Randomized Controlled Trial Comparing Treatment Effectiveness of Guideline Indicated Anti-platelet Therapy for Acute Coronary Syndrome in Patients With Chronic Kidney Disease [NCT03150667] | Phase 4 | 220 participants (Anticipated) | Interventional | 2017-04-10 | Recruiting |
Pharmacodynamic Evaluation of Antiplatelet Effect of Swallowing Versus Chewing Ticagrelor in Patients With Acute Coronary Syndrome [NCT04567290] | Phase 4 | 50 participants (Anticipated) | Interventional | 2020-10-07 | Recruiting |
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization [NCT02211066] | Phase 4 | 59 participants (Actual) | Interventional | 2014-10-31 | Completed |
Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) [NCT02486367] | Phase 4 | 60 participants (Actual) | Interventional | 2015-06-30 | Completed |
An Open Label, Two Arms, Randomized Controlled Pilot Study Comparing the Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable Coronary Artery Disease Treated With Ticagrelor Monotherapy or Ticagrelor and Asprin [NCT02219412] | Phase 4 | 70 participants (Actual) | Interventional | 2014-08-31 | Completed |
Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study [NCT01642940] | Phase 4 | 30 participants (Actual) | Interventional | 2012-06-30 | Completed |
Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis: The VISTA Trial [NCT05885932] | | 472 participants (Anticipated) | Interventional | 2023-08-25 | Recruiting |
The Risk of Major Bleeding With Novel Anti-platelets: A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome [NCT02484924] | | 5,225 participants (Actual) | Observational | 2010-06-30 | Completed |
A Two-Cohort, Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Chinese Volunteers Living in China [NCT00721448] | Phase 1 | 24 participants (Anticipated) | Interventional | 2008-06-30 | Completed |
A Randomised, Double-Blind, Two-Period Crossover Study to Assess the Effect of AZD6140 on Uric Acid Levels in Healthy Male Volunteers [NCT00738842] | Phase 1 | 24 participants (Actual) | Interventional | 2008-05-31 | Completed |
A Study of Platelet Function Test in the Application of Prevention of Ischemic Events After Stent Placement in Intracranial Aneurysms [NCT03989557] | Phase 4 | 314 participants (Actual) | Interventional | 2019-07-01 | Completed |
The Effect of Intravenous Cangrelor and Oral Ticagrelor on Platelets, the Microcirculation and Myocardial Damage in Patients Admitted With STEMI Treated by Primary Percutaneous Coronary Intervention: A Randomized Controlled Pilot Trial [NCT02733341] | Phase 4 | 100 participants (Actual) | Interventional | 2016-07-21 | Completed |
A Phase 2a Single Dose Study to Evaluate the Effect of BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Patients With Stable Coronary Artery Disease and Healthy Participants [NCT05093790] | Phase 2 | 58 participants (Actual) | Interventional | 2022-03-25 | Completed |
A Randomised, Double-Blind, Parallel Group, Asian, Multicenter Study, to Assess Pharmacokinetic and Pharmacodynamic Profile of 2 Doses of Ticagrelor on Top of Low Dose Acetyl Salicylic Acid (ASA) Therapy on Platelet Aggregation in Japanese and Asian Patie [NCT01118325] | Phase 2 | 146 participants (Actual) | Interventional | 2010-04-30 | Completed |
Chewing Versus Traditional Oral Administration of Ticagrelor in ST-elevation Myocardial Infarction Patients - A Platelet Reactivity Study [NCT02725099] | Phase 4 | 50 participants (Actual) | Interventional | 2016-05-31 | Completed |
Optimizing Timing of Coronary Artery Bypass Surgery in Patients Presenting With Acute Coronary Syndrome and Treated With Second Generation ADP Receptor Antagonist [NCT02627521] | Phase 4 | 260 participants (Anticipated) | Interventional | 2015-07-31 | Recruiting |
The Effects of loW Dose tIcagrelor on Platelet Function Testing in Patients With Stable Coronary arTery Disease: TWIST Trial [NCT04206176] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2019-10-01 | Completed |
The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI [NCT02658838] | Phase 4 | 300 participants (Anticipated) | Interventional | 2015-04-30 | Active, not recruiting |
Prasugrel Or Ticagrelor De-escalation in Non-ST-elevation Acute Coronary Syndrome [NCT05779059] | Phase 3 | 50 participants (Anticipated) | Interventional | 2023-04-01 | Not yet recruiting |
Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction [NCT02627950] | Phase 4 | 138 participants (Actual) | Interventional | 2015-12-31 | Completed |
Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome: the Randomized, Multicenter, Double-blind ELECTRA RCT Study [NCT04718025] | Phase 3 | 4,500 participants (Anticipated) | Interventional | 2022-02-07 | Recruiting |
Influence of METHoxyflurane on ANtiplatelet Effect of Ticagrelor in Patients With Unstable Angina Pectoris - METHANE Study [NCT04442919] | Phase 4 | 75 participants (Anticipated) | Interventional | 2020-06-01 | Recruiting |
Dual Antiplatelet Therapy With Ticagrelor and Acetylsalicylic Acid (ASA) vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patient With Acute Coronary Syndrome [NCT03560310] | Phase 4 | 2,200 participants (Anticipated) | Interventional | 2018-06-29 | Recruiting |
Effect of Ticagrelor on Endothelial Function [NCT01805596] | Phase 3 | 45 participants (Anticipated) | Interventional | 2013-04-30 | Completed |
The Impact of Administration Strategy of Ticagrelor on Its Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris - a Randomized, Single-center, Open-label Pilot Study [NCT02612116] | Phase 4 | 49 participants (Actual) | Interventional | 2015-09-30 | Completed |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) [NCT05047172] | Phase 3 | 1,683 participants (Anticipated) | Interventional | 2022-08-02 | Recruiting |
MULTIcentric Study About RESistance to CLOpidogrel in Dual Antiplatelet Therapy for Carotid Stenting [NCT05566301] | | 1,140 participants (Anticipated) | Observational | 2021-09-02 | Recruiting |
ANTIPLATELET TREATMENT IN ACUTE CORONARY SYNDROMES. SAFETY AND EFFICACY OF ANTIPLATELET SWITCHING Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome [NCT04630288] | | 1,900 participants (Actual) | Observational | 2019-07-02 | Active, not recruiting |
Evaluation the Effect of Ticagrelor and Clopidogrel in Stable Coronary Syndrome A Randomized Clinical Trial [NCT05858918] | | 476 participants (Actual) | Interventional | 2022-10-01 | Completed |
Overcoming High On-Treatment Platelet Reactivity (HPR) During Prasugrel Therapy [NCT01869309] | Phase 4 | 400 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
RE-DUAL PCI Real Life Registry Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI [NCT04688723] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2020-12-23 | Recruiting |
Platelet Function Evaluation in Patients With Acute Coronary Syndromes on Potent P2Y12 Inhibitor Monotherapy Versus Dual Antiplatelet Therapy With Aspirin and a Potent P2Y12 Inhibitor [NCT05767723] | Phase 4 | 48 participants (Anticipated) | Interventional | 2023-02-06 | Recruiting |
Effects of Ticagrelor Versus Prasugrel on Coronary Microcirculation in Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the PROtecting MICROcirculation During Coronary Angioplasty (PROMICRO)-3 Randomised Study [NCT05643586] | Phase 4 | 50 participants (Actual) | Interventional | 2017-12-01 | Completed |
Ticagrelor Monotherapy After Coronary Stenting in Patients With Acute Myocardial Infarction - A Prospective Single-centre, Single-arm Phase II Study [NCT05149560] | Phase 2 | 200 participants (Anticipated) | Interventional | 2021-12-04 | Recruiting |
Cangrelor Administration Following Ticagrelor Loading vs Ticagrelor Loading Alone in ST Segment Elevation Myocardial Infarction Patients: A Randomized, Pharmacodynamic Study [NCT02943369] | Phase 4 | 30 participants (Actual) | Interventional | 2017-07-28 | Completed |
Differences in the Pharmacokinetic and Pharmacodynamic Profile of Ticagrelor and Its Active Metabolite AR-C124900XX Between Patients With Unstable Angina Pectoris Treated With Crushed Ticagrelor and a Combination of Morphine and Metoclopramide or Morphine [NCT02939235] | Phase 4 | 32 participants (Actual) | Interventional | 2016-07-31 | Completed |
A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese [NCT01294462] | Phase 3 | 801 participants (Actual) | Interventional | 2011-02-28 | Completed |
Comparison of Circadian Variability of Platelet Inhibition in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor [NCT03454841] | | 73 participants (Actual) | Observational | 2018-02-26 | Completed |
The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction [NCT05045274] | | 300 participants (Anticipated) | Interventional | 2021-12-31 | Not yet recruiting |
The Impact of Genotype on Pharmacokinetics and Antiplatelet Effects of Ticagrelor in Healthy Chinese [NCT03092076] | Phase 1 | 51 participants (Actual) | Interventional | 2015-05-20 | Completed |
[NCT03016611] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-02-28 | Not yet recruiting |
Study of the Effect of Ticagrelor and Clopidogrel on the Immune Response of Healthy Volunteers [NCT01846559] | Phase 4 | 30 participants (Actual) | Interventional | 2013-04-30 | Completed |
Prospective, Randomized, Open Label Trial of 6 Months vs. 12 Months Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction [NCT01459627] | Phase 4 | 1,100 participants (Anticipated) | Interventional | 2011-12-31 | Completed |
Standard Versus Low Dose Maintenance Ticagrelor After Primary Percutaneous Intervention for STEMI in Diabetic Patients: a Randomized Controlled Trial [NCT05831462] | Phase 1/Phase 2 | 400 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-P [NCT04006288] | Phase 4 | 90 participants (Actual) | Interventional | 2019-09-06 | Completed |
Effect of Antiplatelet Therapies in Patients With Depression and Coronary Disease [NCT05821062] | | 400 participants (Anticipated) | Observational | 2022-04-14 | Recruiting |
CLOpidogrel Versus TIcagreLor for Antiplatelet Maintenance in DIAbetic Patients Treated With Percutaneous Coronary Intervention: Results of the CLOTILDIA Study [NCT02742987] | Phase 4 | 42 participants (Actual) | Interventional | 2014-03-31 | Completed |
Differences in the Pharmacokinetic and Pharmacodynamic Profile of Ticagrelor and Its Active Metabolite AR-C124900XX Between Patients With Unstable Angina Pectoris Treated With Crushed Ticagrelor and a Combination of Morphine and Naloxone or Morphine Alone [NCT02939248] | Phase 4 | 30 participants (Actual) | Interventional | 2016-10-31 | Completed |
Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery [NCT03789916] | Phase 3 | 800 participants (Anticipated) | Interventional | 2019-01-02 | Recruiting |
Ticagrelor Compared to Clopidogrel in Acute Coronary Syndromes - the TC4 Comparative Effectiveness Study [NCT04057300] | Phase 4 | 1,038 participants (Actual) | Interventional | 2018-10-01 | Completed |
A Randomised, Double Blind, Parallel Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Number of Vaso-Occlusive Crises in Paediatric Patients Aged 6 Months to <18 Years With Sickle Cell Disease (HESTIA [NCT04293172] | Phase 3 | 0 participants (Actual) | Interventional | 2020-06-30 | Withdrawn(stopped due to Study halted prematurely, prior to enrolment of first patient.) |
A Dose Blocked-randomized, Double-blind, Active and Placebo Controlled, Single and Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect [NCT01526577] | Phase 1 | 113 participants (Actual) | Interventional | 2012-03-31 | Completed |
An Open Label, Single Centre, Randomised, Phase IV, Pharmacokinetic, Pharmacodynamic, and Safety Study to Evaluate Single and Multiple Doses of 45, 60, and 90 mg of Ticagrelor in Chinese Patients With Stable Coronary Heart Disease [NCT02064985] | Phase 4 | 61 participants (Actual) | Interventional | 2014-02-28 | Completed |
The Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage [NCT05986968] | | 200 participants (Anticipated) | Interventional | 2023-07-06 | Recruiting |
Comparison of Therapy With TICAGRELOR, Prasugrel and High Clopidogrel Dose in PCI Patients With High on Treatment Platelet Reactivity and Genotype Variation [NCT01543932] | Phase 3 | 81 participants (Actual) | Interventional | 2012-07-31 | Completed |
Efficacy, Safety and Tolerability of PrasugrEl 5mg or TIcagrelor 60mg in COmplex and Higher-Risk Indicated PCI/PatieNts: The Prospective, Randomized, Open-labeled, Blinded Endpoint (PROBE), Multi-center E5TION Trial [NCT04734353] | Phase 4 | 492 participants (Anticipated) | Interventional | 2020-01-15 | Recruiting |
Rapid Activity of Platelet Inhibitor Drugs Study (RAPID 2) [NCT01805570] | Phase 4 | 50 participants (Actual) | Interventional | 2012-11-30 | Completed |
A Prospective, Multi-center, Optical Coherence Tomography Guided Reperfusion Strategy in Patients With STEMI (EROSION II) [NCT03062826] | | 347 participants (Actual) | Observational | 2017-01-11 | Active, not recruiting |
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI): a Multi-center Randomized Parallel Pharmacodynamic Study. [NCT01575795] | Phase 4 | 83 participants (Actual) | Interventional | 2012-04-30 | Completed |
[NCT02487732] | Phase 4 | 60 participants (Actual) | Interventional | 2015-07-31 | Completed |
Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel [NCT05247385] | Phase 4 | 87 participants (Actual) | Interventional | 2017-03-20 | Completed |
THE CAPITAL PCI AF Study: The Safety and Efficacy of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention [NCT03331484] | Phase 3 | 40 participants (Actual) | Interventional | 2018-11-01 | Active, not recruiting |
A Pharmacodynamic Study Comparing Prasugrel Versus Ticagrelor in Patients With Coronary Artery Disease Undergoing PCI With CYP2C19 Loss-of-function Genotypes: A Feasibility Study With Point-of-care Pharmacodynamic and Genetic Testing [NCT02065479] | Phase 4 | 65 participants (Actual) | Interventional | 2014-03-31 | Completed |
Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics Profile Among Coronary Artery Disease (CAD) Patients Undergoing Percutaneous Coronary Intervention (PCI) [NCT05516784] | Phase 4 | 80 participants (Actual) | Interventional | 2019-09-01 | Completed |
A Study of the Transition From Cangrelor to Ticagrelor, and Ticagrelor to Cangrelor in Patients With Coronary Artery Disease [NCT01766466] | Phase 2 | 12 participants (Actual) | Interventional | 2013-01-31 | Completed |
Normalizing Platelet Reactivity After Treatment With Ticagrelor [NCT02201394] | Phase 4 | 20 participants (Actual) | Interventional | 2014-07-31 | Completed |
Sampling P2Y12 Receptor Inhibition With Prasugrel and Ticagrelor in Patients Submitted to Thrombolysis After Loading Dose of Clopidogrel [NCT02215993] | Phase 4 | 50 participants (Actual) | Interventional | 2013-07-31 | Completed |
Differential Effect of Ticagrelor Versus Prasugrel on the Adenosine-induced Coronary Vasodilatory Responses in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. [NCT01642966] | Phase 4 | 56 participants (Actual) | Interventional | 2012-09-30 | Completed |
A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the Effect of Ticagrelor on the Pharmacokinetics, Safety, a [NCT01504906] | Phase 1 | 20 participants (Actual) | Interventional | 2012-01-31 | Completed |
Rapid Activity of Platelet Inhibitor Drugs Study [NCT01510171] | Phase 4 | 50 participants (Actual) | Interventional | 2012-01-31 | Completed |
Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis [NCT01511471] | Phase 3 | 20 participants (Actual) | Interventional | 2012-01-31 | Completed |
Effect of Modifying Anti-platelet Treatment to Ticagrelor in Patients With Diabetes and Low Response to Clopidogrel [NCT01643031] | Phase 4 | 500 participants (Anticipated) | Interventional | 2012-08-31 | Not yet recruiting |
A Randomised Mechanistic Study Comparing the Effects of Different Anti-platelet Combinations (Ticagrelor vs. Placebo/ Clopidogrel) With Aspirin in Patients Presenting With Anterior STEMI Treated With Primary PCI [NCT03145194] | Phase 2 | 140 participants (Anticipated) | Interventional | 2017-01-30 | Recruiting |
Reassessment of Anti-Platelet Therapy Using InDividualized Strategies -Ticagrelor in Patients With Acute Coronary Syndromes Treated by Coronary Artery Bypass Graft Surgery - A Pharmacodynamic and Clinical Study to Decrease Bleeding Risks and Ischemic Comp [NCT02668562] | | 143 participants (Actual) | Interventional | 2016-02-29 | Completed |
Ticagrelor vs. Tirofiban, Comparison of Anti-platelet Effects in Patients With Non-ST Elevation Acute Coronary Syndrome(TE-CLOT Trial : Ticagrelor's Effect for CLOT Prevention) ; A Single Center, Open-label Randomized Controlled Study [NCT01660373] | Phase 3 | 100 participants (Anticipated) | Interventional | 2012-08-31 | Recruiting |
Comparative Efficacy of Ticagrelor Versus Aspirin on Blood Viscosity in Peripheral Artery Disease (PAD) Patients With Type 2 Diabetes (T2D) [NCT02325466] | Phase 3 | 70 participants (Actual) | Interventional | 2015-04-30 | Completed |
Effects of Clopidogrel vs Prasugel vs Ticagrelor on Endothelial Function, Inflammatory and Oxidative Stress Parameters and Platelet Function in Patients Undergoing Coronary Artery Stenting. A Randomised, Prospective Study. [NCT01700322] | Phase 4 | 126 participants (Actual) | Interventional | 2012-08-31 | Completed |
Smart Angioplasty Research Team: Safety of 6-month Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes (SMART-DATE) [NCT01701453] | | 2,712 participants (Actual) | Interventional | 2012-08-31 | Active, not recruiting |
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease [NCT01706510] | Phase 4 | 28 participants (Actual) | Interventional | 2012-12-31 | Completed |
Effects of Ticagrelor and Intracoronary Morphine on Myocardial Salvage in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [NCT01738100] | Phase 2 | 100 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting |
On-treatment PLAtelet Reactivity-guided Therapy Modification FOR ST-segment Elevation Myocardial Infarction (PLATFORM) [NCT01739556] | Phase 3 | 242 participants (Actual) | Interventional | 2015-06-30 | Terminated(stopped due to An interim analysis showed that there is no difference in the primary endpoint, given the small number of events in the groups examined.) |
A Open Label, Randomized, Crossover and Potential Parallel, Single Dose Study of Ticagrelor 180 mg and Acetylsalicylic Acid (ASA) in Healthy Volunteers Followed by Autologous in Vivo Platelet Transfusion to Determine the Effects of Platelet Supplementatio [NCT01744288] | Phase 1 | 258 participants (Actual) | Interventional | 2012-12-31 | Completed |
A Randomized, Parallel Group, Double-Blind Study of Ticagrelor Compared With Aspirin for Prevention of Vascular Events in Patients Undergoing Coronary Artery Bypass Graft Operation TiCAB- Ticagrelor in CABG [NCT01755520] | Phase 3 | 1,893 participants (Actual) | Interventional | 2013-04-24 | Terminated(stopped due to DSMB Interim Analyses) |
Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients With Coronary Heart Disease: A Randomized, Open Label, Crossover Study [NCT01757262] | Phase 3 | 0 participants (Actual) | Interventional | 2013-01-31 | Withdrawn |
A REAl-life Study on Short-term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or Transient Ischemic Attack [NCT05476081] | | 1,067 participants (Anticipated) | Observational [Patient Registry] | 2021-02-03 | Recruiting |
A Prospective, Randomized, Controlled, Analyst-blinded, Parallel Group Study to Investigate the Effect of Antithrombotic Triple Therapy With Ticagrelor and Acetylsalicylic Acid in Combination With Dabigatran or Rivaroxaban or Phenprocoumon on Markers of C [NCT01812200] | Phase 4 | 60 participants (Actual) | Interventional | 2012-10-31 | Completed |
The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention [NCT01812330] | Phase 3 | 180 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
Bedside Testing of the CYP2C19 Gene to Asses Effectiveness of Clopidogrel in Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention : Individualized Antiplatelet Drugs Treatment to Improve Prognosis [NCT01823185] | Phase 4 | 1,500 participants (Anticipated) | Interventional | 2013-03-31 | Recruiting |
Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study [NCT01826175] | Phase 4 | 0 participants (Actual) | Interventional | 2013-05-31 | Withdrawn(stopped due to Study terminated mutually by sponsor & PI due to no enrollment) |
The ACS Ethnicity Platelet Function Study [NCT01829659] | | 4 participants (Actual) | Observational | 2013-05-31 | Completed |
Relationship of Dose of Ticagrelor and Anti-inflammatory Effect in Patients With End Stage Renal Disease on Hemodialysis: PIANO-6 Randomized Crossover Study [NCT02406911] | Phase 3 | 25 participants (Anticipated) | Interventional | 2015-02-28 | Recruiting |
Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention [NCT01919723] | Phase 2 | 70 participants (Actual) | Interventional | 2014-02-28 | Completed |
Tailored Antiplatelet Initiation to Lesson Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) [NCT01742117] | Phase 4 | 5,276 participants (Actual) | Interventional | 2013-05-31 | Completed |
Impact of Ticagrelor Re-load on Pharmacodynamic Profiles in Patients on Maintenance Ticagrelor Therapy [NCT01731041] | | 60 participants (Actual) | Interventional | 2013-01-31 | Completed |
A head-to Head Comparison of the Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease [NCT01852175] | | 110 participants (Actual) | Interventional | 2012-01-31 | Completed |
A Prospective, Randomized, Open-Label, Multicenter Study Assessing Efficacy and Safety of Ticagrelor De-escalation Strategy in East Asian Acute Myocardial Infarction With Coronary Intervention: EASTYLE Trial [NCT04755387] | Phase 4 | 2,000 participants (Anticipated) | Interventional | 2021-02-15 | Recruiting |
A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System [NCT01589978] | Phase 4 | 2,681 participants (Actual) | Interventional | 2012-05-31 | Completed |
Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction [NCT02931045] | Phase 4 | 60 participants (Actual) | Interventional | 2017-12-30 | Completed |
Randomized, Crossover Study of the Antithrombotic Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin When Administered With Bivalirudin [NCT01642238] | Phase 4 | 15 participants (Actual) | Interventional | 2012-07-31 | Completed |
Pharmacodynamic Evaluation of Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease [NCT02287909] | Phase 4 | 87 participants (Actual) | Interventional | 2014-12-31 | Completed |
A Phase IV, Randomised, Multi-Centre, Open Label Study, Comparing Ticagrelor Versus Clopidogrel in Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI) With Bivalirudin [NCT02052635] | Phase 4 | 34 participants (Actual) | Interventional | 2014-09-30 | Terminated(stopped due to Patient recruitment challenges, low enrolment, and a forecasted inability to complete the study in an acceptable timeframe) |
Comparative Study of the Antithrombotic Effects of Ticagrelor and Clopidogrel in Type 2 Diabetic Patients [NCT01823510] | Phase 4 | 20 participants (Actual) | Interventional | 2013-07-31 | Completed |
Tailoring Bleeding Reduction Approaches in Patients Undergoing Percutaneous Coronary Interventions: Comparative Pharmacodynamic Effects of Potent P2Y12 Inhibitor Monotherapy Versus Dual Antiplatelet Therapy De-escalation [NCT05681702] | Phase 4 | 90 participants (Anticipated) | Interventional | 2023-02-15 | Recruiting |
Replication of the ISAR-REACT 5 Antiplatelet Trial in Healthcare Claims Data [NCT05086081] | | 28,389 participants (Actual) | Observational | 2020-10-10 | Completed |
Replication of the PLATO Antiplatelet Trial in Healthcare Claims Data [NCT04237935] | | 27,960 participants (Actual) | Observational | 2019-09-22 | Completed |
Ticagrelor in Comparison to Prasugrel for Early Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI) [NCT01463163] | Phase 4 | 50 participants (Actual) | Interventional | 2011-10-31 | Completed |
Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg Twice Daily in Elderly Patients With Acute Coronary Syndrome (ACS) [NCT04739384] | Phase 3 | 50 participants (Actual) | Interventional | 2021-04-01 | Completed |
A Randomized Comparison of Platelet Inhibition Using a Low Maintenance Dose Ticagrelor Regimen Versus Standard Dose Clopidogrel in Diabetes Mellitus Patients Without Prior Major Cardiovascular Events Undergoing Elective Percutaneous Coronary Intervention: [NCT03437044] | Phase 4 | 40 participants (Actual) | Interventional | 2018-03-14 | Completed |
Efficacy and Safety of Different Ticagrelor Regimens Versus Clopidogrel in Patients With Coronary Artery Disease: a Retrospective Multicenter Study (SUPERIOR) [NCT03381742] | Phase 2/Phase 3 | 3,043 participants (Actual) | Interventional | 2017-12-13 | Completed |
A Multi-centre, Phase I, Open-label, Single-dose Study to Investigate Pharmacokinetics (PK) of Ticagrelor in Infants and Toddlers, Aged 0 to Less Than 24 Months, With Sickle Cell Disease (HESTIA4) [NCT03492931] | Phase 1 | 21 participants (Actual) | Interventional | 2018-03-28 | Completed |
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI2452 (PB2452) With and Without Ticagrelor Pretreatment in Healthy Volunteers [NCT03492385] | Phase 1 | 64 participants (Actual) | Interventional | 2018-04-03 | Completed |
Prospective, Randomized Study of the Platelet Inhibitory Efficacy of Ticagrelor Versus Prasugrel in Clopidogrel Low Responders After Percutaneous Coronary Intervention [NCT01456364] | Phase 4 | 70 participants (Anticipated) | Interventional | 2011-09-30 | Recruiting |
The Impact of Ticagrelor on Coronary Atherosclerotic Lipid Pool and Inflammation Assessed by Near-Infrared Spectroscopy [NCT02282332] | Phase 4 | 30 participants (Actual) | Interventional | 2014-06-30 | Completed |
A Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease: 2nd Switching Antiplatelet Agents [NCT01587651] | Phase 4 | 110 participants (Actual) | Interventional | 2012-03-31 | Completed |
Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients [NCT03435133] | | 61 participants (Actual) | Interventional | 2015-11-23 | Completed |
24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial [NCT04989257] | | 3,488 participants (Anticipated) | Interventional | 2021-08-31 | Not yet recruiting |
A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ti [NCT01991795] | Phase 3 | 19,271 participants (Actual) | Interventional | 2014-02-10 | Completed |
In Vitro Pharmacodynamic Effects of Cangrelor on Platelet P2Y12 Receptor Mediated Signaling in Ticagrelor Treated Patients [NCT02081443] | | 60 participants (Actual) | Interventional | 2014-04-30 | Completed |
Single-center, Double-blind (ACT-246475), Open-label (Clopidogrel, Prasugrel, and Ticagrelor), Placebo-controlled, Randomized, Two-way Crossover Study to Investigate the Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of Clopidogrel or, P [NCT03430661] | Phase 1 | 77 participants (Actual) | Interventional | 2018-01-24 | Completed |
A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Incidence of Major Cardiovascular Events of Ticagrelor in Chinese Patients With Acute Coronary Syndrome(ACS) [NCT01870921] | Phase 4 | 2,004 participants (Actual) | Interventional | 2013-06-26 | Completed |
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency After Coronary Bypass? [NCT02053909] | Phase 4 | 250 participants (Actual) | Interventional | 2014-09-30 | Completed |
Effect of Upstream Treatment With High Intensity Statin on the Outcomes of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention [NCT04754789] | Phase 3 | 160 participants (Anticipated) | Interventional | 2021-02-20 | Not yet recruiting |
Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry [NCT01515345] | Phase 3 | 1,008 participants (Actual) | Interventional | 2011-07-31 | Completed |
Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT [NCT03197298] | | 2,062 participants (Actual) | Observational [Patient Registry] | 2012-12-21 | Completed |
Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence: A Parallel Single-blinded Randomized Trial [NCT05474053] | Phase 3 | 29 participants (Actual) | Interventional | 2021-11-13 | Completed |
Comparison of Coronary Artery Bypass Graft Surgery Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel [NCT04431349] | | 1,097 participants (Actual) | Observational | 2016-01-01 | Completed |
Evaluation of Platelet Aggregation and Adenosine Levels in Patients With Coronary Artery Disease and Chronic Kidney Dysfunction Taking Dual Antiplatelet Therapy With Aspirin and Clopidogrel or Ticagrelor [NCT03039205] | Phase 2 | 90 participants (Actual) | Interventional | 2017-11-07 | Completed |
An Open-label, Randomised, Four-period, Four-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioavailability of Ticagrelor Orodispersible Tablets, Compared to Ticagrelor Immediate-release Tablets in Healthy Subjects [NCT02400333] | Phase 1 | 100 participants (Actual) | Interventional | 2015-06-30 | Completed |
Reducing Inflammation in Ischemic Stroke With Colchicine, and Ticagrelor in High-risk Patients-extended Treatment in Ischemic Stroke [NCT05476991] | Phase 3 | 2,800 participants (Anticipated) | Interventional | 2023-05-17 | Recruiting |
Escalated Single Platelet Inhibition for One Month Plus Direct Oral Anticoagulation in Patients With Atrial Fibrillation and acUte coRonary Syndrome Undergoing percutaneoUS Coronary Intervention [NCT04981041] | Phase 4 | 2,334 participants (Anticipated) | Interventional | 2021-12-16 | Recruiting |
[NCT02494895] | Phase 4 | 3,056 participants (Anticipated) | Interventional | 2015-08-01 | Recruiting |
Chewed Versus Integral Pill of Ticagrelor in All Patients Undergoing Percutaneous Coronary intervention--a Platelet Reactivity and Patient Outcomes Study. [NCT03708588] | Phase 4 | 112 participants (Actual) | Interventional | 2018-09-19 | Completed |
A Phase II Multicentre, Randomised, Double-Blind, Controlled, Parallel-Group Study to Evaluate the Walking Time Effect of Long-Term Ticagrelor in Comparison to Long-Term Aspirin Administration in Ambulatory Patients With Peripheral Artery Disease Undergoi [NCT02227368] | Phase 2 | 40 participants (Actual) | Interventional | 2014-10-20 | Terminated |
Non-interventional Prospective Data Collection on Persistence and Adherence on Ticagrelor in ACS Adult Patients in Serbia [NCT03444012] | | 269 participants (Actual) | Observational | 2018-03-05 | Completed |
The Use of BRILInta to Optimize ANTiplatelet Therapy (BRILIANT) Registry: The BRILIANT KOREA Registry [NCT02521038] | | 2,000 participants (Anticipated) | Observational [Patient Registry] | 2015-07-31 | Recruiting |
Adjunctive Vorapaxar Therapy in Patients With Prior Myocardial Infarction Treated With New Generation P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor (VORA-PRATIC): A Prospective, Randomized, Pharmacodynamic Study [NCT02545933] | Phase 4 | 130 participants (Actual) | Interventional | 2016-02-29 | Completed |
A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrom [NCT02293395] | Phase 2 | 3,037 participants (Actual) | Interventional | 2015-04-20 | Completed |
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia [NCT02230527] | Phase 2/Phase 3 | 46 participants (Actual) | Interventional | 2014-10-31 | Terminated(stopped due to Lack of enrollment) |
A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Cumulative Incidence of Major Cardiovascular Events of Ticagrelor in Taiwanese Patients With Non ST-segment Elevation Myocardial Infarction [NCT02406248] | Phase 4 | 108 participants (Actual) | Interventional | 2015-04-23 | Completed |
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study [NCT02091921] | Phase 1/Phase 2 | 53 participants (Actual) | Interventional | 2014-02-16 | Completed |
Ticagrelor Administered as Standard Tablet or orodispersiblE foRmulation [NCT03822377] | Phase 3 | 130 participants (Actual) | Interventional | 2019-06-27 | Completed |
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects [NCT01734772] | Phase 1 | 48 participants (Actual) | Interventional | 2012-11-30 | Completed |
Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia [NCT01998399] | Phase 2 | 25 participants (Actual) | Interventional | 2014-08-31 | Terminated(stopped due to poor enrollment, unable to meet recruitment goals) |
Safety of Ticagrelor Plus Warfarin Versus Clopidogrel+Aspirin+Warfarin in Patients With Persistent or Permanent Atrial Fibrillation and Undergoing PCI-S: A Randomized, Open, Controlled, Parallel Group, Multi-center Trial [NCT02206815] | Phase 4 | 296 participants (Actual) | Interventional | 2014-09-19 | Completed |
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions [NCT04744571] | | 200 participants (Anticipated) | Interventional | 2021-02-28 | Enrolling by invitation |
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? ) [NCT01992523] | Phase 3 | 82 participants (Actual) | Interventional | 2013-11-30 | Completed |
Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention [NCT01962428] | Phase 4 | 250 participants (Actual) | Interventional | 2014-06-30 | Completed |
Effect of the Peripheral Opioid Receptor Antagonist Methylnaltrexone on the Pharmacokinetic and Pharmacodynamic Profiles of Ticagrelor in Patients Receiving Morphine: a Prospective, Randomized Placebo-controlled Trial [NCT02403830] | Phase 4 | 30 participants (Actual) | Interventional | 2015-08-31 | Completed |
Pharmacokinetics and Pharmacodynamics of Platelet P2Y12 Inhibitors in Patients Undergoing Percutaneous Coronary Intervention (PCI) for Acute Myocardial Infarction: A Pilot Study [NCT02376283] | Phase 4 | 87 participants (Actual) | Interventional | 2015-03-09 | Completed |
A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Effect of Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI [NCT04338919] | | 2,020 participants (Anticipated) | Interventional | 2020-04-14 | Recruiting |
Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis [NCT02874092] | Phase 4 | 9 participants (Actual) | Interventional | 2016-11-15 | Completed |
Efficacy and Safety of Ticagrelor Combined With ASA Versus ASA Alone in Preventing Stroke and Death in Patients With Acute Ischemic Stroke or Transient Ischemic Attack: a Randomized, Double-blind, Placebo-controlled, International Multicenter Phase III Cl [NCT04962451] | Phase 4 | 13,000 participants (Actual) | Interventional | 2017-09-01 | Completed |
Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT) [NCT04946929] | Phase 3 | 50 participants (Anticipated) | Interventional | 2021-07-31 | Not yet recruiting |
A Randomized, Double-Blind, Placebo-Controlled Trial Investigating The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery (The POPular CABG Study) [NCT02352402] | Phase 3 | 487 participants (Anticipated) | Interventional | 2015-03-31 | Active, not recruiting |
A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting [NCT02330640] | Phase 4 | 137 participants (Actual) | Interventional | 2016-01-31 | Completed |
Pivotal Study of the AggreGuide A-100 Adenosine Diphosphate (ADP) Assay to Evaluate the Detection of Platelet Dysfunction Due to P2Y12 Antiplatelet Drugs [NCT03111420] | | 280 participants (Actual) | Interventional | 2017-01-09 | Completed |
Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial [NCT03078465] | Phase 3 | 0 participants (Actual) | Interventional | 2017-06-20 | Withdrawn(stopped due to Competitive studies were conducted at the same time, and enrollment was suspended.) |
Reassessment of Long-Term Dual Anti-Platelet Therapy Using InDividualized Strategies - Using a Novel Combined Demographic and Pharmacogenomic Strategy: The RAPID EXTEND Pilot Study [NCT03224923] | Phase 4 | 5 participants (Actual) | Interventional | 2017-08-18 | Terminated(stopped due to Competing study to be started in November 2018) |
Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention [NCT04999293] | | 1,505 participants (Actual) | Observational | 2021-07-20 | Completed |
Cangrelor vs. Ticagrelor for Early Platelet Inhibition in ST-elevation Myocardial Infarction [NCT03182855] | Phase 4 | 80 participants (Anticipated) | Interventional | 2018-09-01 | Not yet recruiting |
Safety and Efficacy of Low-Dose Ticagrelor in Chinese Patients With Non-ST-Elevation Acute Coronary Syndrome: A Randomized Clinical Trial [NCT02415803] | Phase 3 | 75 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
Dose Adaptation to Offset the Pharmacokinetic Interaction Between Ticagrelor and Ritonavir in Healthy Volunteers by Population-based PK Modeling (Simcyp®) [NCT02435563] | Phase 2 | 22 participants (Actual) | Interventional | 2014-08-31 | Completed |
A Single Dose, Randomized, Open-Label, Parallel Group Study Comparing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ticagrelor in Hemodialysis Patients to Subjects With Normal Renal Function [NCT02022748] | Phase 1 | 27 participants (Actual) | Interventional | 2013-12-29 | Completed |
Investigation of Anti-platelet Drug Single Dose Exposure on Platelet mRNA Splicing in Healthy Subjects [NCT04088123] | | 0 participants (Actual) | Observational | 2020-04-01 | Withdrawn(stopped due to Inability to commence enrollment at institution, terminated on 9/23/20) |
The Relationship Between Genotype and Platelet Reactivity in Patients Treated With Ticagrelor Versus Clopidogrel: PIANO Genotype Study [NCT02394145] | Phase 3 | 20 participants (Anticipated) | Interventional | 2009-09-30 | Recruiting |
Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure. [NCT03103685] | Phase 4 | 428 participants (Anticipated) | Interventional | 2017-05-01 | Not yet recruiting |
Reversal of the Anti-platelet Effects of Ticagrelor in Healthy Persons and Patients With Coronary Artery Disease [NCT02383771] | Phase 4 | 64 participants (Actual) | Interventional | 2015-03-31 | Completed |
Ndividualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI [NCT05911659] | | 60 participants (Anticipated) | Observational [Patient Registry] | 2023-05-01 | Recruiting |
Evaluation of the Effects and Plasma Concentration of the Potent Platelet Inhibitor Ticagrelor, After Crushed and Non-crushed Intake, After Semi-urgent Coronary Bypass and in Patients After Cardiac Arrest. [NCT02341729] | Phase 4 | 40 participants (Actual) | Interventional | 2015-03-31 | Completed |
Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction [NCT02075125] | Phase 3 | 39 participants (Actual) | Interventional | 2014-01-31 | Terminated(stopped due to Enrolling participants has halted prematurely and will not resume) |
EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy [NCT02244710] | | 109 participants (Actual) | Interventional | 2015-03-31 | Completed |
Multicenter, Open-label, Randomised, Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor Followed by a Double-blind, Randomised, Parallel-group, Placebo-controlled 4 Weeks Extension Phase in Paediatric Patients With Sic [NCT02214121] | Phase 2 | 46 participants (Actual) | Interventional | 2014-09-11 | Completed |
A Pharmacodynamic Comparison of Prasugrel vs. Ticagrelor in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease [NCT01852214] | | 50 participants (Actual) | Interventional | 2013-02-28 | Completed |
An Open-label, Randomized, Three-period, Three-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Healthy Japanese Subjects. [NCT02436577] | Phase 1 | 51 participants (Actual) | Interventional | 2015-06-30 | Completed |
A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease [NCT01732822] | Phase 3 | 13,885 participants (Actual) | Interventional | 2012-12-04 | Completed |
SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month [NCT03606642] | Phase 2 | 50 participants (Actual) | Interventional | 2018-11-19 | Active, not recruiting |
"The Value of Screening for High on Treatment Platelet Reactivity in Patients Undergoing Lower Extremity Arterial Endovascular Interventions" [NCT04007055] | Phase 3 | 296 participants (Anticipated) | Interventional | 2019-08-09 | Recruiting |
GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation [NCT01813435] | Phase 3 | 15,991 participants (Actual) | Interventional | 2013-07-01 | Completed |
Efficacy and Safety of Individualized P2Y12 Receptor Antagonists Treatment Based on Agregometry Versus Fixed Dose Regimen in Patients After Acute Myocardial Infarction [NCT04369534] | Phase 4 | 120 participants (Actual) | Interventional | 2015-12-01 | Completed |
Pharmacodynamic Effects of Different Ticagrelor Maintenance Dosing Regimens With and Without Aspirin in Patients With Diabetes Mellitus: The OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-7 Study [NCT04484259] | Phase 4 | 63 participants (Anticipated) | Interventional | 2021-03-31 | Recruiting |
Pharmacodynamic Profiles of Ticagrelor in Patients With ST Elevation Myocardial Infarction: A Randomized Comparison of Different Loading Dosage Regimens [NCT01898442] | Phase 2 | 52 participants (Actual) | Interventional | 2013-09-30 | Completed |
Platelet Aggregation During Pharmacological Shift From Clopidogrel to Ticagrelor in Patients With Acute Coronary Syndrome [NCT01795820] | | 50 participants (Actual) | Interventional | 2012-11-30 | Completed |
A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease [NCT03008083] | Phase 4 | 2,446 participants (Anticipated) | Interventional | 2019-01-10 | Recruiting |
Ticagrelor Therapy for RefrACTORy Migraine Study Pilot (TRACTOR) [NCT02518464] | Phase 4 | 40 participants (Actual) | Interventional | 2015-10-31 | Completed |
Reversal of the Antiplatelet Effects of Ticagrelor in Combination With Aspirin, Using Normal Platelets [NCT03005704] | | 10 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy M [NCT01595854] | Phase 1 | 36 participants (Actual) | Interventional | 2012-05-31 | Completed |
"Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel in Patients Undergoing One-stop Hybrid Coronary Revascularization" [NCT02513004] | Phase 4 | 60 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
A Randomized, Open-label, Active-Controlled and Blinded-Endpoint Trial Comparing the Antiplatelet Effects of Ticagrelor Plus Aspirin Versus Clopidogrel Plus Aspirin in Chinese Patients With High-risk Transient Ischemic Attack or Minor Stroke. [NCT02506140] | Phase 2/Phase 3 | 675 participants (Actual) | Interventional | 2015-08-31 | Completed |
Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Trial [NCT02514642] | Phase 4 | 30 participants (Anticipated) | Interventional | 2015-07-31 | Recruiting |
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes; Pharmacodynamics and Pharmacokinetics Study [NCT02319941] | Phase 2 | 65 participants (Actual) | Interventional | 2015-05-20 | Completed |
A Prospective, Multicentre, Randomized, Open Label, Blinded Endpoint, Phase 3 Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr With Acetylsalicylic Acid Versus CLopidogrel With Acetylsalicylic Acid in the Development of Cerebrovascular E [NCT02989558] | Phase 3 | 90 participants (Actual) | Interventional | 2016-12-31 | Completed |
A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3366 in Healthy Men and Women of Non-Childbearing Potential Following: Part A: Single Ascending Dose Administrati [NCT04588727] | Phase 1 | 103 participants (Actual) | Interventional | 2020-10-15 | Completed |
An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome [NCT04023630] | Phase 4 | 4,000 participants (Anticipated) | Interventional | 2019-10-01 | Not yet recruiting |
Evaluation of Ticagrelor Pharmacokinetics in Patients With Non-ST Elevation Myocardial Infarction After a 180 mg Ticagrelor Loading Dose [NCT02292277] | | 63 participants (Actual) | Observational | 2014-10-31 | Completed |
Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [NCT02270242] | Phase 4 | 9,006 participants (Actual) | Interventional | 2015-07-31 | Completed |
A Randomised, Double-blind, Double-dummy, Parallel-group, Multicenter, Phase IIb Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Number of Days With Pain in Young Adults With Sickle Cell Disease [NCT02482298] | Phase 2 | 87 participants (Actual) | Interventional | 2015-07-09 | Completed |
A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus C [NCT02164864] | Phase 3 | 2,725 participants (Actual) | Interventional | 2014-07-22 | Completed |
Low-dose of Ticagrelor and Standard-dose Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study [NCT03679091] | Phase 4 | 36 participants (Actual) | Interventional | 2018-08-29 | Completed |
An Open-label, Randomized, 4-period, 4-treatment, Cross-over, Single-center, Single-dose Study to Assess the Relative Bioavailability of Ticagrelor in Different Formulations in Healthy Adult Subjects [NCT03126695] | Phase 1 | 44 participants (Actual) | Interventional | 2017-05-12 | Completed |
Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention [NCT03381755] | Phase 4 | 200 participants (Anticipated) | Interventional | 2018-01-01 | Recruiting |
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Hispanic Patients With Stable Coronary Artery Disease [NCT01523366] | Phase 4 | 53 participants (Actual) | Interventional | 2012-04-30 | Completed |
A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary [NCT01864005] | Phase 4 | 60 participants (Actual) | Interventional | 2013-05-31 | Completed |
Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery [NCT02201771] | Phase 4 | 500 participants (Actual) | Interventional | 2014-07-31 | Completed |
An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [NCT01830543] | Phase 3 | 2,124 participants (Actual) | Interventional | 2013-05-10 | Completed |
Pharmacodynamic Outcomes in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention Treated With an Individualized Treatment STRATEGY [NCT05773989] | Phase 4 | 88 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events With Ticagrelor Compared to Aspirin (ASA) in Patients With Acute Ischaemic Stroke or TIA. [NCT01994720] | Phase 3 | 13,307 participants (Actual) | Interventional | 2014-01-07 | Completed |
Pharmacodynamic Evaluation of Switching From Prasugrel to Ticagrelor: The SWAP (SWitching Anti Platelet)-3 Study [NCT02016170] | | 82 participants (Actual) | Interventional | 2014-03-31 | Completed |
TIPRIS: Ticagrelor vs. Prasugrel Effects on Infarct Size: A Head to Head Comparison With Prasugrel [NCT02507323] | Phase 2 | 0 participants (Actual) | Interventional | 2016-02-29 | Withdrawn(stopped due to collaborator withdrew the study) |
Effect of Haemodialysis on the Efficacy of Antiplatelet Agents [NCT03330223] | | 60 participants (Anticipated) | Observational | 2017-11-10 | Recruiting |
The Success of Opening Concurrent Chronic Total Occlusion leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease (SOS-moral): Study Protocol of a Prospective Multicenter Study [NCT03372785] | | 240 participants (Anticipated) | Observational [Patient Registry] | 2018-04-10 | Enrolling by invitation |
A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19 [NCT04505774] | Phase 4 | 880 participants (Actual) | Interventional | 2020-09-04 | Active, not recruiting |
Role of Innate and Adaptive Immunity After Acute Myocardial Infarction BATTLE-AMI Study (B And T Types of Lymphocytes Evaluation in Acute Myocardial Infarction) [NCT02428374] | Phase 4 | 300 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
Impact of Ticagrelor and Aspirin Versus Clopidogrel and Aspirin in Patients With Claudication and Peripheral Arterial Disease (PAD): Thrombus Burden Assessed by Optical Coherence Tomography [NCT02407314] | Phase 4 | 26 participants (Actual) | Interventional | 2015-06-30 | Terminated(stopped due to AZ discontinued study) |
Sub Lingual Versus Traditional Oral Administration of Ticagrelor in Acute Coronary Syndrome [NCT02402400] | Phase 4 | 50 participants (Actual) | Interventional | 2015-07-31 | Completed |
An Open Label, Randomized Study to Determine the Rate of Cardiovascular Events at 1 yr for Patients With Elevated Troponins Post Major Non-cardiac Surgery and the Impact of Ticagrelor vs Aspirin on the Occurrence of Cardiovascular Events [NCT02291419] | Phase 4 | 6 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to Enrollment expectations were not met) |
Comparison of Antiplatelet Therapy With Clopidogrel and Ticagrelor in Patients After Cardiac Arrest Treated With Therapeutic Hypothermia [NCT02224274] | Phase 4 | 57 participants (Actual) | Interventional | 2014-08-31 | Completed |
A Single Center, Randomized, Open Label, Crossover Study With Ticagrelor and Prasugrel to Evaluate Ticagrelor Mechanism of Action in Inhibiting Juvenile Platelet ADP Response [NCT03027934] | Phase 4 | 0 participants (Actual) | Interventional | 2017-08-28 | Withdrawn(stopped due to Study population difficult to recruit) |
A Randomized, Double-blind Study Evaluating the Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor and Its Active Metabolite (AR-C124910XX) in Patients With ST-segment Elevation Myocardial Infarction and Non-ST-segment Elevation [NCT02217878] | Phase 4 | 74 participants (Actual) | Interventional | 2014-08-31 | Completed |
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in African American Patients With Stable Coronary Artery Disease [NCT01523392] | Phase 4 | 50 participants (Actual) | Interventional | 2012-03-31 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00391872 (16) [back to overview] | Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke |
NCT00391872 (16) [back to overview] | Participants With Major or Minor Bleeding |
NCT00391872 (16) [back to overview] | Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding |
NCT00391872 (16) [back to overview] | Participants With Stroke |
NCT00391872 (16) [back to overview] | Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization |
NCT00391872 (16) [back to overview] | Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization |
NCT00391872 (16) [back to overview] | Participants With MI Event |
NCT00391872 (16) [back to overview] | Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events. |
NCT00391872 (16) [back to overview] | Participants With Non-procedural Major Bleeding |
NCT00391872 (16) [back to overview] | Participants With Death From Vascular Causes |
NCT00391872 (16) [back to overview] | Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization |
NCT00391872 (16) [back to overview] | Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke |
NCT00391872 (16) [back to overview] | Participants With Death From Any Cause |
NCT00391872 (16) [back to overview] | Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding |
NCT00391872 (16) [back to overview] | Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding |
NCT00391872 (16) [back to overview] | Participants With Any Major Bleeding Event |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose |
NCT00528411 (45) [back to overview] | Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: RR |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: RV |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: SpO2 |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: TLC |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: VE |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: VT |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose |
NCT00528411 (45) [back to overview] | Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose |
NCT00528411 (45) [back to overview] | Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Residual Volume (RV) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters at Post 6-week Treatment: FVC |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: EF |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: FRC |
NCT00528411 (45) [back to overview] | Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP |
NCT00642811 (6) [back to overview] | Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15 |
NCT00642811 (6) [back to overview] | Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28 |
NCT00642811 (6) [back to overview] | Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop. |
NCT00642811 (6) [back to overview] | Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15 |
NCT00642811 (6) [back to overview] | Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.) |
NCT00642811 (6) [back to overview] | Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28 |
NCT01118325 (11) [back to overview] | IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients |
NCT01118325 (11) [back to overview] | AR-C124910XX (AUC0-tau) at Week 4 |
NCT01118325 (11) [back to overview] | AR-C124910XX (Cmax) at Week 4 |
NCT01118325 (11) [back to overview] | AR-C124910XX (Tmax) at Week 4 |
NCT01118325 (11) [back to overview] | AZD6140 (AUC0-tau) at Week 4 |
NCT01118325 (11) [back to overview] | AZD6140 (Cmax) at Week 4 |
NCT01118325 (11) [back to overview] | AZD6140 (Tmax) at Week 4 |
NCT01118325 (11) [back to overview] | Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients |
NCT01118325 (11) [back to overview] | IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients |
NCT01118325 (11) [back to overview] | IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients |
NCT01118325 (11) [back to overview] | IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients |
NCT01225562 (4) [back to overview] | Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization |
NCT01225562 (4) [back to overview] | Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization |
NCT01225562 (4) [back to overview] | Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients |
NCT01225562 (4) [back to overview] | Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization |
NCT01294462 (4) [back to overview] | Major Adverse Cardiac Events (MACE) |
NCT01294462 (4) [back to overview] | Composite of All-cause Mortality, MI or Stroke |
NCT01294462 (4) [back to overview] | Major Bleeding |
NCT01294462 (4) [back to overview] | Major and Minor Bleeding |
NCT01347580 (12) [back to overview] | Major Bleeds Within 48 Hours |
NCT01347580 (12) [back to overview] | Major Bleeds After 48 Hours |
NCT01347580 (12) [back to overview] | Definite Stent Thrombosis |
NCT01347580 (12) [back to overview] | 2nd Composite Clinical Endpoint |
NCT01347580 (12) [back to overview] | 1st Composite Clinical Endpoint |
NCT01347580 (12) [back to overview] | Minor and Major Bleeds After 48 Hours |
NCT01347580 (12) [back to overview] | Minor and Major Bleedings Within 48 Hours |
NCT01347580 (12) [back to overview] | TIMI Flow Grade 3 Post -PCI |
NCT01347580 (12) [back to overview] | Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI |
NCT01347580 (12) [back to overview] | Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint) |
NCT01347580 (12) [back to overview] | ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint) |
NCT01347580 (12) [back to overview] | ST Segment Elevation Resolution Post-PCI >= 70% |
NCT01515345 (3) [back to overview] | Any Bleeding Event |
NCT01515345 (3) [back to overview] | Probable Stent Thrombosis |
NCT01515345 (3) [back to overview] | Definite Stent Thrombosis |
NCT01523366 (5) [back to overview] | Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses |
NCT01523366 (5) [back to overview] | Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 |
NCT01523366 (5) [back to overview] | Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose |
NCT01523366 (5) [back to overview] | AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses |
NCT01523366 (5) [back to overview] | Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose |
NCT01523392 (5) [back to overview] | Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose |
NCT01523392 (5) [back to overview] | Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 |
NCT01523392 (5) [back to overview] | Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose |
NCT01523392 (5) [back to overview] | AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses |
NCT01523392 (5) [back to overview] | Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses |
NCT01526577 (1) [back to overview] | Pharmacodynamic Measurement |
NCT01587651 (6) [back to overview] | P2Y12 Reaction Units |
NCT01587651 (6) [back to overview] | P2Y12 Reaction Units |
NCT01587651 (6) [back to overview] | Percentage of Subjects With High On-treatment Platelet Reactivity |
NCT01587651 (6) [back to overview] | Platelet Reactivity Index |
NCT01587651 (6) [back to overview] | PRU Percent Inhibition (Calculated) |
NCT01587651 (6) [back to overview] | PRU Percent Inhibition (Device-reported) |
NCT01589978 (21) [back to overview] | All Death or Myocardial Infarction Rate |
NCT01589978 (21) [back to overview] | All Death Rate |
NCT01589978 (21) [back to overview] | ARC ST Rate in PLATINUM-like Population. |
NCT01589978 (21) [back to overview] | Cardiac Death or Myocardial Infarction (MI) Rate |
NCT01589978 (21) [back to overview] | Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients |
NCT01589978 (21) [back to overview] | Cardiac Death Rate |
NCT01589978 (21) [back to overview] | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients |
NCT01589978 (21) [back to overview] | Major Adverse Cardiac Event Rate (MACE) |
NCT01589978 (21) [back to overview] | Myocardial Infarction (MI) Rate |
NCT01589978 (21) [back to overview] | Non-cardiac Death Rate |
NCT01589978 (21) [back to overview] | Rate of Cardiac Death Events Related to the PROMUS Element Stent |
NCT01589978 (21) [back to overview] | Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent |
NCT01589978 (21) [back to overview] | Rate of Longitudinal Stent Deformation |
NCT01589978 (21) [back to overview] | Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent |
NCT01589978 (21) [back to overview] | Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent |
NCT01589978 (21) [back to overview] | Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent |
NCT01589978 (21) [back to overview] | Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent |
NCT01589978 (21) [back to overview] | Target Vessel Failure (TVF) Rate |
NCT01589978 (21) [back to overview] | Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients |
NCT01589978 (21) [back to overview] | Target Vessel Revascularization (TVR) Rate |
NCT01589978 (21) [back to overview] | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients |
NCT01595854 (3) [back to overview] | Number of Participants With Drug Related Adverse Events |
NCT01595854 (3) [back to overview] | Total Dabigatran: Maximum Measured Concentration (Cmax) |
NCT01595854 (3) [back to overview] | Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) |
NCT01603082 (2) [back to overview] | Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™ |
NCT01603082 (2) [back to overview] | Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™ |
NCT01642238 (8) [back to overview] | Platelet-thrombus Formation in an ex Vivo Model of Thrombosis |
NCT01642238 (8) [back to overview] | Platelet Reactivity |
NCT01642238 (8) [back to overview] | Blood Thrombogenicity |
NCT01642238 (8) [back to overview] | Platelet Reactivity |
NCT01642238 (8) [back to overview] | Platelet-thrombus Formation in an ex Vivo Model of Thrombosis |
NCT01642238 (8) [back to overview] | Platelet Reactivity |
NCT01642238 (8) [back to overview] | Blood Thrombogenicity |
NCT01642238 (8) [back to overview] | Blood Thrombogenicity |
NCT01731041 (2) [back to overview] | Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP) |
NCT01731041 (2) [back to overview] | P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12 |
NCT01732822 (24) [back to overview] | MI |
NCT01732822 (24) [back to overview] | Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other]) |
NCT01732822 (24) [back to overview] | Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke |
NCT01732822 (24) [back to overview] | Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic) |
NCT01732822 (24) [back to overview] | Composite of CV Death, MI, Ischemic Stroke, and ALI |
NCT01732822 (24) [back to overview] | CV Death |
NCT01732822 (24) [back to overview] | CV-related Hospitalization |
NCT01732822 (24) [back to overview] | All-cause Mortality |
NCT01732822 (24) [back to overview] | Major Amputation Caused by PAD |
NCT01732822 (24) [back to overview] | Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding) |
NCT01732822 (24) [back to overview] | Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding) |
NCT01732822 (24) [back to overview] | Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding) |
NCT01732822 (24) [back to overview] | Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding) |
NCT01732822 (24) [back to overview] | Non-CV Death |
NCT01732822 (24) [back to overview] | PLATO Major Bleeding Events |
NCT01732822 (24) [back to overview] | TIMI Major Bleeding Events |
NCT01732822 (24) [back to overview] | Changes in Rutherford Classification |
NCT01732822 (24) [back to overview] | TIMI Major or Minor Bleeding Events |
NCT01732822 (24) [back to overview] | Change in ABI/TBI From Baseline |
NCT01732822 (24) [back to overview] | Lower Extremity Revascularization |
NCT01732822 (24) [back to overview] | Changes in Fontaine Stage |
NCT01732822 (24) [back to overview] | ALI |
NCT01732822 (24) [back to overview] | Any Amputation Caused by PAD |
NCT01732822 (24) [back to overview] | Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event |
NCT01734772 (2) [back to overview] | Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss) |
NCT01734772 (2) [back to overview] | Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) |
NCT01742117 (4) [back to overview] | Thrombolysis in Myocardial Infarction Major or Minor Bleeding |
NCT01742117 (4) [back to overview] | Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. |
NCT01742117 (4) [back to overview] | Occurrence of the a Major Adverse Cardiovascular Event |
NCT01742117 (4) [back to overview] | Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan. |
NCT01766466 (3) [back to overview] | Extent of Aggregation Response During Ticagrelor Treatment |
NCT01766466 (3) [back to overview] | Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor |
NCT01766466 (3) [back to overview] | Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1) |
NCT01813435 (9) [back to overview] | Number of Participants With a Stroke |
NCT01813435 (9) [back to overview] | Number of Participants With New Q-wave Myocardial Infarction |
NCT01813435 (9) [back to overview] | Number of Participants With Myocardial Infarction |
NCT01813435 (9) [back to overview] | Number of Participants With All-cause Mortality |
NCT01813435 (9) [back to overview] | Number of Participants With a Myocardial Revascularisation |
NCT01813435 (9) [back to overview] | Number of Participants With a Definite Stent Thrombosis |
NCT01813435 (9) [back to overview] | Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction |
NCT01813435 (9) [back to overview] | Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI) |
NCT01813435 (9) [back to overview] | Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding |
NCT01823510 (4) [back to overview] | Platelet Reactivity Index (PRI) |
NCT01823510 (4) [back to overview] | Platelet Reactivity |
NCT01823510 (4) [back to overview] | P2Y12 Reaction Unit (PRU) |
NCT01823510 (4) [back to overview] | Thrombus Formation |
NCT01830543 (9) [back to overview] | Percentage of Participants With Stroke |
NCT01830543 (9) [back to overview] | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding |
NCT01830543 (9) [back to overview] | Percentage of Participants With Bleeding Requiring Medical Attention (BRMA) |
NCT01830543 (9) [back to overview] | Percentage of Participants With Cardiovascular Death |
NCT01830543 (9) [back to overview] | Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke) |
NCT01830543 (9) [back to overview] | Percentage of Participants With Clinically Significant Bleeding |
NCT01830543 (9) [back to overview] | Percentage of Participants With Myocardial Infarction |
NCT01830543 (9) [back to overview] | Percentage of Participants With Stent Thrombosis |
NCT01830543 (9) [back to overview] | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding |
NCT01852175 (3) [back to overview] | Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) |
NCT01852175 (3) [back to overview] | Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP) |
NCT01852175 (3) [back to overview] | Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP) |
NCT01852214 (4) [back to overview] | P2Y12 Reaction Units |
NCT01852214 (4) [back to overview] | Platelet Reactivity Index |
NCT01852214 (4) [back to overview] | Platelet Reactivity Index |
NCT01852214 (4) [back to overview] | P2Y12 Reaction Units |
NCT01864005 (5) [back to overview] | the Percentage Inhibition of the P2Y12 Receptor |
NCT01864005 (5) [back to overview] | the Percentage Inhibition of the P2Y12 Receptor |
NCT01864005 (5) [back to overview] | the Percentage Inhibition of the P2Y12 Receptor |
NCT01864005 (5) [back to overview] | the Percentage Inhibition of the P2Y12 Receptor |
NCT01864005 (5) [back to overview] | the Percentage Inhibition of the P2Y12 Receptor |
NCT01870921 (3) [back to overview] | Bleeding Events |
NCT01870921 (3) [back to overview] | Serious Adverse Events Other Than Bleeding |
NCT01870921 (3) [back to overview] | Major CV Events |
NCT01898442 (6) [back to overview] | Platelet Reactivity by VerifyNow P2Y12 |
NCT01898442 (6) [back to overview] | Pharmacokinetic Profiles of Ticagrelor (Tmax) |
NCT01898442 (6) [back to overview] | Pharmacokinetic Profiles of Ticagrelor (Cmax) |
NCT01898442 (6) [back to overview] | Pharmacokinetic Profiles of Ticagrelor (AUC0-t) |
NCT01898442 (6) [back to overview] | Platelet Reactivity by VerifyNow P2Y12 at Other Time Points |
NCT01898442 (6) [back to overview] | Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points |
NCT01919723 (4) [back to overview] | Bleeding Complications |
NCT01919723 (4) [back to overview] | Change in Percent Inhibition of Platelet Aggregation (%IPA) |
NCT01919723 (4) [back to overview] | Periprocedural Myocardial Infarction (PMI) |
NCT01919723 (4) [back to overview] | High On-treatment Platelet Reactivity (HPR) |
NCT01962428 (1) [back to overview] | Platelet Reactivity Index(PRI) Measured by VASP-P |
NCT01991795 (9) [back to overview] | TIMI Major Bleeding Event (Primary Safety Objective) |
NCT01991795 (9) [back to overview] | TIMI Major or Minor Bleeding Event |
NCT01991795 (9) [back to overview] | All-cause Death |
NCT01991795 (9) [back to overview] | Composite of Cardiovascular (CV) Death, MI or Stroke |
NCT01991795 (9) [back to overview] | CV Death |
NCT01991795 (9) [back to overview] | Ischaemic Stroke |
NCT01991795 (9) [back to overview] | MI |
NCT01991795 (9) [back to overview] | Permanent Discontinuation of Study Medication Due to Any Bleeding Event |
NCT01991795 (9) [back to overview] | PLATO Major Bleeding Event |
NCT01992523 (4) [back to overview] | Bleeding Events |
NCT01992523 (4) [back to overview] | Dyspnoea and/or Symptomatic Bradycardia |
NCT01992523 (4) [back to overview] | Residual Platelet Reactivity |
NCT01992523 (4) [back to overview] | High Residual Platelet Reactivity |
NCT01994720 (18) [back to overview] | Number of Participants With Composite of Ischaemic Stroke, MI and CV Death |
NCT01994720 (18) [back to overview] | Net Clinical Outcome |
NCT01994720 (18) [back to overview] | Number of Participants With All-Cause Death |
NCT01994720 (18) [back to overview] | Number of Participants by Severity of Stroke and Overall Disability |
NCT01994720 (18) [back to overview] | EQ-5D at Visit 2 (Day 7+-2d) |
NCT01994720 (18) [back to overview] | EQ-5D at Visit 1 (Enrolment) |
NCT01994720 (18) [back to overview] | EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit |
NCT01994720 (18) [back to overview] | EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit |
NCT01994720 (18) [back to overview] | Change in NIHSS |
NCT01994720 (18) [back to overview] | Number of Participants With Stroke |
NCT01994720 (18) [back to overview] | Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event |
NCT01994720 (18) [back to overview] | Number of Participants With PLATO Major Bleeding Event |
NCT01994720 (18) [back to overview] | Number of Participants With MI |
NCT01994720 (18) [back to overview] | Number of Participants With Ischaemic Stroke |
NCT01994720 (18) [back to overview] | Number of Participants With Fatal Stroke |
NCT01994720 (18) [back to overview] | Number of Participants With Disabling Stroke |
NCT01994720 (18) [back to overview] | Number of Participants With CV Death |
NCT01994720 (18) [back to overview] | Number of Participants With Composite of Stroke/MI/Death |
NCT01998399 (13) [back to overview] | Ventilator Free Days |
NCT01998399 (13) [back to overview] | Time to Initiation of Unassisted Breathing |
NCT01998399 (13) [back to overview] | Stroke, Myocardial Infarct, Mortality |
NCT01998399 (13) [back to overview] | Stroke |
NCT01998399 (13) [back to overview] | Hospital Length of Stay |
NCT01998399 (13) [back to overview] | Shock Free Days |
NCT01998399 (13) [back to overview] | Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support) |
NCT01998399 (13) [back to overview] | Need for Dialysis |
NCT01998399 (13) [back to overview] | Myocardial Infarction |
NCT01998399 (13) [back to overview] | In-hospital Mortality |
NCT01998399 (13) [back to overview] | ICU Length of Stay |
NCT01998399 (13) [back to overview] | All-cause Mortality |
NCT01998399 (13) [back to overview] | Hospital Free Days |
NCT02016170 (2) [back to overview] | Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay |
NCT02016170 (2) [back to overview] | Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP). |
NCT02022748 (6) [back to overview] | Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX |
NCT02022748 (6) [back to overview] | Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor |
NCT02022748 (6) [back to overview] | Pharmacokinetic Parameter Cmax of AR-C124910XX |
NCT02022748 (6) [back to overview] | Pharmacokinetic Parameter Cmax of Ticagrelor |
NCT02022748 (6) [back to overview] | Pharmacokinetic Parameter t1/2 of AR-C124910XX |
NCT02022748 (6) [back to overview] | Pharmacokinetic Parameter t1/2 of Ticagrelor |
NCT02052635 (2) [back to overview] | P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose |
NCT02052635 (2) [back to overview] | P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose |
NCT02053909 (2) [back to overview] | Saphenous Vein Graft Stenosis |
NCT02053909 (2) [back to overview] | Saphenous Vein Graft Occlusion |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1) |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Phosphate |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Ticagrelor on Day 1(1) |
NCT02064985 (52) [back to overview] | Safety---Hematology Laboratory Variables Over Time---Hemoglobin |
NCT02064985 (52) [back to overview] | Safety---Hematology Laboratory Variables Over Time---Leukocytes |
NCT02064985 (52) [back to overview] | Safety---Hematology Laboratory Variables Over Time---Platelets |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Ticagrelor on Day 7(3) |
NCT02064985 (52) [back to overview] | Safety---Vital Signs Over Time---Height |
NCT02064985 (52) [back to overview] | Safety---Vital Signs Over Time---Weight |
NCT02064985 (52) [back to overview] | TIPA(Max)---Day 1 |
NCT02064985 (52) [back to overview] | TIPA(Max)---Day 7 |
NCT02064985 (52) [back to overview] | IPA on Day 1 |
NCT02064985 (52) [back to overview] | IPA on Day 7 |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Ticagrelor on Day 7(1) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Ticagrelor on Day 7(2) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Ticagrelor on Day 7(4) |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Albumin |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Bicarbonate |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Chloride |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Creatinine |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Glucose |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Potassium |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Protein |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Sodium |
NCT02064985 (52) [back to overview] | AUEC(Final Extent) on Day 1 |
NCT02064985 (52) [back to overview] | Safety---Hematology Laboratory Variables Over Time---Erythrocytes |
NCT02064985 (52) [back to overview] | Safety---Hematology Laboratory Variables Over Time---hematocrit |
NCT02064985 (52) [back to overview] | Percent Change From Baseline in PRU on Day 1 |
NCT02064985 (52) [back to overview] | Percent Change From Baseline in PRU on Day 7 |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Ticagrelor on Day 1(2) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Ticagrelor on Day 1(3) |
NCT02064985 (52) [back to overview] | Safety---All Allowed Concomitant Medications During Study Treatment |
NCT02064985 (52) [back to overview] | Safety---Causally Related Adverse Events by System Organ Class and Preferred Term |
NCT02064985 (52) [back to overview] | Safety---Physical Examination, Summary of Abnormalities |
NCT02064985 (52) [back to overview] | AUEC(Final Extent) on Day 7 |
NCT02064985 (52) [back to overview] | Safety---Clinical Chemistry Variables Over Time---Total Bilirubin |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h) |
NCT02064985 (52) [back to overview] | Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax |
NCT02064985 (52) [back to overview] | Safety---Vital Signs Over Time---Blood Pressure |
NCT02064985 (52) [back to overview] | Safety---Vital Signs Over Time---Pulse Rate |
NCT02065479 (1) [back to overview] | Platelet Reactivity |
NCT02075125 (7) [back to overview] | Adverse Drug Reaction |
NCT02075125 (7) [back to overview] | Bleeding Event |
NCT02075125 (7) [back to overview] | Major Adverse Cardiac and Cerebrovascular Events |
NCT02075125 (7) [back to overview] | Pre-procedure P2Y12 Reaction Units (PRU) |
NCT02075125 (7) [back to overview] | Pre-procedure Platelet Reactivity Index (PRI) |
NCT02075125 (7) [back to overview] | Number of Participants With High Platelet Reactivity |
NCT02075125 (7) [back to overview] | Number of Participants With Low Platelet Reactivity |
NCT02081443 (3) [back to overview] | Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP) |
NCT02081443 (3) [back to overview] | PRI Measured by VASP |
NCT02081443 (3) [back to overview] | PRI Measured by VASP |
NCT02091921 (4) [back to overview] | To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI. |
NCT02091921 (4) [back to overview] | Establish the Number of Participants in the High On-treatment Platelet Reactivity (HPR) on Clopidogrel Group Who Demonstrated Appropriate Platelet Inhibition (API) After Switching to Ticagrelor for Two Weeks. |
NCT02091921 (4) [back to overview] | Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy. |
NCT02091921 (4) [back to overview] | Establish the Number of Participants With Appropriate Platelet Inhibition on Clopidogrel Who Demonstrated Appropriate Platelet Inhibition After Switching to Ticagrelor for Two Weeks. |
NCT02164864 (13) [back to overview] | Time to First Adjudicated Stroke |
NCT02164864 (13) [back to overview] | Time to First Adjudicated Unplanned Revascularisation by PCI/CABG |
NCT02164864 (13) [back to overview] | Time to First Adjudicated ST |
NCT02164864 (13) [back to overview] | Time to First Adjudicated SE |
NCT02164864 (13) [back to overview] | Time to First Adjudicated MI |
NCT02164864 (13) [back to overview] | Time to First Adjudicated ISTH MBE or CRNMBE |
NCT02164864 (13) [back to overview] | Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG |
NCT02164864 (13) [back to overview] | Time to Composite Endpoint of Death or First Thrombotic Event |
NCT02164864 (13) [back to overview] | Time to Composite Endpoint of Death + MI + Stroke |
NCT02164864 (13) [back to overview] | Time to Adjudicated Undetermined Cause of Death |
NCT02164864 (13) [back to overview] | Time to Adjudicated Non-CV |
NCT02164864 (13) [back to overview] | Time to Adjudicated CV |
NCT02164864 (13) [back to overview] | Time to Adjudicated All Cause Death |
NCT02201394 (2) [back to overview] | P2Y12 Reaction Unit (PRU) |
NCT02201394 (2) [back to overview] | Platelet Aggregation Using Multiplate Analyzer |
NCT02201771 (6) [back to overview] | The Number of Major Adverse Cardiovascular Event (MACE) |
NCT02201771 (6) [back to overview] | Number of the Major Bleeding Events |
NCT02201771 (6) [back to overview] | The Rate of Post-operative Atrial Fibrillation After CABG. |
NCT02201771 (6) [back to overview] | The Patency of Saphenous Vein Grafts |
NCT02201771 (6) [back to overview] | The Patency of Saphenous Vein Grafts |
NCT02201771 (6) [back to overview] | The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification |
NCT02214121 (30) [back to overview] | Assessment of AR-C124910XX Concentration - Part A |
NCT02214121 (30) [back to overview] | P2Y12 Reaction Units (PRU) - Part A |
NCT02214121 (30) [back to overview] | P2Y12 Reaction Units (PRU) - Part A |
NCT02214121 (30) [back to overview] | P2Y12 Reaction Units (PRU) - Part A |
NCT02214121 (30) [back to overview] | P2Y12 Reaction Units (PRU) - Part B |
NCT02214121 (30) [back to overview] | Mean Intensity of Pain (Age >=4) - Part B |
NCT02214121 (30) [back to overview] | Maximum Plasma Concentration (Cmax) - Part B |
NCT02214121 (30) [back to overview] | Area Under the Plasma Concentration Time Curve (AUC) - Part A |
NCT02214121 (30) [back to overview] | Area Under the Plasma Concentration Time Curve (AUC) - Part B |
NCT02214121 (30) [back to overview] | Haemorrhagic Events - Part A |
NCT02214121 (30) [back to overview] | Haemorrhagic Events - Part B |
NCT02214121 (30) [back to overview] | Maximum Plasma Concentration (Cmax) - Part A |
NCT02214121 (30) [back to overview] | Number of Vaso-occlusive Crises - Part B |
NCT02214121 (30) [back to overview] | Number of Vaso-occlusive Crises Requiring Hospitalization or Emergency Department Visits - Part B |
NCT02214121 (30) [back to overview] | Oral Clearance (CL/F) - Part A |
NCT02214121 (30) [back to overview] | Oral Clearance (CL/F) - Part B |
NCT02214121 (30) [back to overview] | Percentage of Days Hospitalized for Vaso-occlusice Crisis or Other Complications of Sickle Cell Disease - Part B |
NCT02214121 (30) [back to overview] | Percentage of Days of Absence From School or Work (Age >=6) - Part B |
NCT02214121 (30) [back to overview] | Percentage of Days of Analgesic Use (Age >= 4) - Part B |
NCT02214121 (30) [back to overview] | Percentage of Days of Opioid Analgesic Use (Age >=4) - Part B |
NCT02214121 (30) [back to overview] | Percentage of Days With Pain (Age >=4) - Part B |
NCT02214121 (30) [back to overview] | Assessment of AR-C124910XX Concentration - Part A |
NCT02214121 (30) [back to overview] | Assessment of AR-C124910XX Concentration - Part A |
NCT02214121 (30) [back to overview] | Assessment of AR-C124910XX Concentration - Part A |
NCT02214121 (30) [back to overview] | Assessment of AR-C124910XX Concentration - Part B |
NCT02214121 (30) [back to overview] | Assessment of Ticagrelor Concentration - Part A |
NCT02214121 (30) [back to overview] | Assessment of Ticagrelor Concentration - Part A |
NCT02214121 (30) [back to overview] | Assessment of Ticagrelor Concentration - Part A |
NCT02214121 (30) [back to overview] | Assessment of Ticagrelor Concentration - Part A |
NCT02214121 (30) [back to overview] | Assessment of Ticagrelor Concentration - Part B |
NCT02217878 (38) [back to overview] | Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h) |
NCT02217878 (38) [back to overview] | Maximum Concentration of AR-C124910XX |
NCT02217878 (38) [back to overview] | Maximum Concentration of Ticagrelor |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h) |
NCT02217878 (38) [back to overview] | Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6) |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h) |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | P2Y12 Reaction Units Assessed by VerifyNow |
NCT02217878 (38) [back to overview] | Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA |
NCT02217878 (38) [back to overview] | Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP |
NCT02217878 (38) [back to overview] | Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Platelet Reactivity Index Assessed by VASP Assay |
NCT02217878 (38) [back to overview] | Time to Maximum Concentration for AR-C124910XX |
NCT02217878 (38) [back to overview] | Time to Maximum Concentration for Ticagrelor |
NCT02217878 (38) [back to overview] | Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA |
NCT02217878 (38) [back to overview] | Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP |
NCT02217878 (38) [back to overview] | Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow |
NCT02224274 (3) [back to overview] | Multiplate ADP Test |
NCT02224274 (3) [back to overview] | VerifyNow P2Y12Test - % Inhibition |
NCT02224274 (3) [back to overview] | VerifyNow P2Y12Test - Platelet Reactivity |
NCT02227368 (2) [back to overview] | Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET) |
NCT02227368 (2) [back to overview] | Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET) |
NCT02230527 (1) [back to overview] | Absolute Change in TcPO2 From Baseline to Month 6 |
NCT02270242 (2) [back to overview] | Number of Participants With BARC Type 2, 3, or 5 |
NCT02270242 (2) [back to overview] | Number of Participants With Ischemic Episode |
NCT02287909 (1) [back to overview] | Platelet Reactivity Unit |
NCT02291419 (6) [back to overview] | Major Adverse Cardiovascular Events |
NCT02291419 (6) [back to overview] | Non-fatal Myocardial Infarction or Coronary Revascularization |
NCT02291419 (6) [back to overview] | Non-fatal Stroke |
NCT02291419 (6) [back to overview] | The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions |
NCT02291419 (6) [back to overview] | All-cause Death |
NCT02291419 (6) [back to overview] | Cardiovascular Death |
NCT02293395 (1) [back to overview] | Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events |
NCT02325466 (4) [back to overview] | Mean Change in Microvascular Blood Flow Composite Score |
NCT02325466 (4) [back to overview] | Mean Change in High Shear Blood Viscosity |
NCT02325466 (4) [back to overview] | Mean Change in Peripheral Arterial Blood Flow |
NCT02325466 (4) [back to overview] | Mean Change in Low Shear Blood Viscosity |
NCT02335099 (2) [back to overview] | Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access |
NCT02335099 (2) [back to overview] | Feasibility and Safety of Ticagrelor in Hemodialysis Patients |
NCT02376283 (3) [back to overview] | Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU) |
NCT02376283 (3) [back to overview] | Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml |
NCT02376283 (3) [back to overview] | Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index) |
NCT02400333 (13) [back to overview] | Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]). |
NCT02400333 (13) [back to overview] | Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX. |
NCT02400333 (13) [back to overview] | Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX. |
NCT02400333 (13) [back to overview] | Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX. |
NCT02400333 (13) [back to overview] | Participants With Significant Findings in 12-Lead Electrocardiography (ECG). |
NCT02400333 (13) [back to overview] | Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis. |
NCT02400333 (13) [back to overview] | Mean Change From Baseline for Vital Signs in Supine Pulse Rate. |
NCT02400333 (13) [back to overview] | Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02400333 (13) [back to overview] | Percentage of Participants With Adverse Events (AEs). |
NCT02400333 (13) [back to overview] | Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP). |
NCT02400333 (13) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02400333 (13) [back to overview] | Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02400333 (13) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02403830 (3) [back to overview] | Platelet Reactivity Measured by VerifyNow P2Y12 |
NCT02403830 (3) [back to overview] | AUC of Ticagrelor Plasma Levels |
NCT02403830 (3) [back to overview] | Platelet Reactivity Measured by VASP |
NCT02436577 (16) [back to overview] | MRCmax (Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights) of Active Metabolite AR-C124910XX |
NCT02436577 (16) [back to overview] | Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02436577 (16) [back to overview] | Terminal Elimination Rate Constant (λz) of Ticagrelor and Its Active Metabolite, AR-C124910XX. |
NCT02436577 (16) [back to overview] | Number of Participants With Adverse Events (AEs) |
NCT02436577 (16) [back to overview] | Mean Residence Time (MRT) of Ticagrelor and Its Active Metabolite AR-C124910XX |
NCT02436577 (16) [back to overview] | Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis. |
NCT02436577 (16) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02436577 (16) [back to overview] | Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02436577 (16) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration AUC (0-t) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02436577 (16) [back to overview] | Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP) |
NCT02436577 (16) [back to overview] | Mean Change From Baseline for Vital Signs in Supine Pulse Rate. |
NCT02436577 (16) [back to overview] | Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) of Ticagrelor and Its Active Metabolite AR-C124910XX. |
NCT02436577 (16) [back to overview] | Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC [0-t]) of Active Metabolite AR-C124910XX |
NCT02436577 (16) [back to overview] | Elimination Rate Constant (Kel) of Ticagrelor and Its Active Metabolite AR-C124910XX |
NCT02436577 (16) [back to overview] | Ratio of Metabolite AUC to Parent AUC, Adjusted for Differences in Molecular Weights (MRAUC) of Active Metabolite AR-C124910XX |
NCT02436577 (16) [back to overview] | Participants With Significant Findings in 12-Lead Electrocardiography (ECG). |
NCT02482298 (5) [back to overview] | Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events) |
NCT02482298 (5) [back to overview] | Change in Proportion of Days With Analgesic Use Measured by an eDiary |
NCT02482298 (5) [back to overview] | Average of the Daily Worst Pain Values Reported Via eDiary |
NCT02482298 (5) [back to overview] | Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary |
NCT02482298 (5) [back to overview] | Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients) |
NCT02486367 (8) [back to overview] | Change in IL-6 as Measured by Blood Test. |
NCT02486367 (8) [back to overview] | Change in D-Dimer Levels as Measured by Blood Test |
NCT02486367 (8) [back to overview] | Change in Mono-2b3a as Measured by Blood Test |
NCT02486367 (8) [back to overview] | Change in Mono-CD62P as Measured by Blood Test |
NCT02486367 (8) [back to overview] | Change in IL-8 as Measured by Blood Test |
NCT02486367 (8) [back to overview] | Platelet Reactivity |
NCT02486367 (8) [back to overview] | Inflammatory Monocyte Proportion |
NCT02486367 (8) [back to overview] | Change in sCD14 as Measured by Blood Test. |
NCT02518464 (1) [back to overview] | Total Number of Responders |
NCT02539160 (2) [back to overview] | Platelet Reactivity Measured by Vasodilator Stimulated Phosphoprotein (VASP) Platelet Reactivity Index (PRI %) |
NCT02539160 (2) [back to overview] | Platelet Reactivity Measured by VerifyNow P2Y12 |
NCT02545933 (1) [back to overview] | Maximal Platelet Aggregation |
NCT02742987 (1) [back to overview] | Flow-mediated Dilation of the Brachial Artery |
NCT02866175 (7) [back to overview] | Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen |
NCT02866175 (7) [back to overview] | Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen |
NCT02866175 (7) [back to overview] | Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen |
NCT02866175 (7) [back to overview] | Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen |
NCT02866175 (7) [back to overview] | Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen |
NCT02866175 (7) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen |
NCT02866175 (7) [back to overview] | Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen |
NCT02874092 (3) [back to overview] | Visual Analog Scale Disease Activity |
NCT02874092 (3) [back to overview] | Disease Activity Score for 28-joint Counts (DAS28) |
NCT02874092 (3) [back to overview] | Change in Brachial Artery Diameter |
NCT02925923 (12) [back to overview] | Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR) |
NCT02925923 (12) [back to overview] | Change in Hemoglobin Levels (g/dL) |
NCT02925923 (12) [back to overview] | A Change in Hematocrit Levels |
NCT02925923 (12) [back to overview] | Number of Patients With Minor Bleeding Complications |
NCT02925923 (12) [back to overview] | Number of Patients With Minor Bleeding Complications |
NCT02925923 (12) [back to overview] | Number of Patients With Major Bleeding Complications |
NCT02925923 (12) [back to overview] | Number of Patients With Major Bleeding Complications |
NCT02925923 (12) [back to overview] | Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI) |
NCT02925923 (12) [back to overview] | Heparin Dose, Unit/Kg |
NCT02925923 (12) [back to overview] | Activated Clotting Time (ACT), Seconds |
NCT02925923 (12) [back to overview] | Platelet Aggregation Levels |
NCT02925923 (12) [back to overview] | Number of Patients With Negative Clinical Outcomes |
NCT02931045 (1) [back to overview] | Concentration of Platelet Extracellular Vesicles/ml |
NCT03354429 (7) [back to overview] | Composite of Subsequent Stroke or Death |
NCT03354429 (7) [back to overview] | ICH or Fatal Bleeding Event |
NCT03354429 (7) [back to overview] | Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe |
NCT03354429 (7) [back to overview] | Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe |
NCT03354429 (7) [back to overview] | Ischaemic Stroke |
NCT03354429 (7) [back to overview] | Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3 |
NCT03354429 (7) [back to overview] | Premature Permanent Discontinuation of IP Due to Bleeding |
NCT03381742 (2) [back to overview] | ADP-induced Platelet-fibrin Clot Strength (MA) |
NCT03381742 (2) [back to overview] | ADP-induced Inhibition of Platelet Aggregation |
NCT03437044 (2) [back to overview] | P2Y12 Reaction Units (PRU) |
NCT03437044 (2) [back to overview] | Platelet Reactivity Index (PRI) |
NCT03489863 (1) [back to overview] | P2Y12 Reaction Unit (PRU) |
NCT03615924 (20) [back to overview] | Percentage of Days of Absence From School or Work Due to Sickle Cell Disease |
NCT03615924 (20) [back to overview] | Type of Analgesics Used by Participants During Vaso-Occlusive Crisis Events |
NCT03615924 (20) [back to overview] | Number of Vaso-Occlusive Crisis Events Requiring Hospitalization or Emergency Department Visits |
NCT03615924 (20) [back to overview] | Number of Sickle Cell-Related Red Blood Cell (RBC) Transfusions |
NCT03615924 (20) [back to overview] | Number of Painful Crisis Events |
NCT03615924 (20) [back to overview] | Number of Days Hospitalized for Vaso-Occlusive Crisis Events |
NCT03615924 (20) [back to overview] | Number of Days Hospitalized for Acute Sickle Cell Disease Complications |
NCT03615924 (20) [back to overview] | Number of Acute Sickle Cell Disease Complications |
NCT03615924 (20) [back to overview] | Number of Vaso-Occlusive Crisis Events |
NCT03615924 (20) [back to overview] | Average Intensity of Worst Pain Daily During Vaso-Occlusive Crisis Events in Participants ≥5 Years of Age |
NCT03615924 (20) [back to overview] | Average Intensity of Worst Pain Daily During Vaso-Occlusive Crisis Events in Participants <5 Years of Age |
NCT03615924 (20) [back to overview] | Duration of Painful Crises |
NCT03615924 (20) [back to overview] | Number of Acute Chest Syndrome Events |
NCT03615924 (20) [back to overview] | Swallowability of the Study Treatment Assessed by Study Medication Palatability Assessment in Participants ≤4 Years of Age |
NCT03615924 (20) [back to overview] | Palatability of the Study Treatment Assessed by Study Medication Palatability Assessment (SMPA) in Participants ≤4 Years of Age |
NCT03615924 (20) [back to overview] | Palatability of the Study Treatment Assessed by Facial Hedonic Scale (FHS) in Participants ≥5 Years of Age |
NCT03615924 (20) [back to overview] | Health-Related Quality of Life Total Score Using the Pediatric Quality of Life Inventory (PedsQL) Sickle Cell Disease Module |
NCT03615924 (20) [back to overview] | Health-Related Quality of Life Total Score Using the Pediatric Quality of Life Inventory (PedsQL) Sickle Cell Disease Module |
NCT03615924 (20) [back to overview] | Fatigue Total Score Using Pediatric Quality of Life Inventory Multidimensional Fatigue Scale |
NCT03615924 (20) [back to overview] | Fatigue Total Score Using Pediatric Quality of Life Inventory Multidimensional Fatigue Scale |
NCT03649711 (2) [back to overview] | ADP Induced Platelet Aggregation |
NCT03649711 (2) [back to overview] | Platelet Surface P-selectin Expression |
NCT03708588 (3) [back to overview] | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) |
NCT03708588 (3) [back to overview] | Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) |
NCT03708588 (3) [back to overview] | Concentration of Pharmacodynamics |
NCT03822377 (6) [back to overview] | Percent of Patients With Insufficient Antiaggregation |
NCT03822377 (6) [back to overview] | Number of Participants With Clinically Relevant Bleeding Events |
NCT03822377 (6) [back to overview] | Number of Participants With Morphine-ticagrelor Interaction |
NCT03822377 (6) [back to overview] | Number of Participants With Residual Platelet Reactivity at Various Timepoints |
NCT03822377 (6) [back to overview] | Evaluation of Platelet Inhibition |
NCT03822377 (6) [back to overview] | Incidence of Adverse Events Occurring During Hospital Stay |
NCT04006288 (1) [back to overview] | Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA) |
NCT05093790 (5) [back to overview] | Number of Participants Experiencing Clinical Lab Abnormalities |
NCT05093790 (5) [back to overview] | Percent Change From Baseline in Thrombus Area |
NCT05093790 (5) [back to overview] | Number of Participants Experiencing Adverse Events (AEs) |
NCT05093790 (5) [back to overview] | Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values |
NCT05093790 (5) [back to overview] | Number of Participants Experiencing Abnormal Vital Signs |
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 901 |
CLOPIDOGREL | 1065 |
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Participants With Major or Minor Bleeding
Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 1339 |
CLOPIDOGREL | 1215 |
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Participants With Stroke
Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 125 |
CLOPIDOGREL | 106 |
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Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists. (NCT00391872)
Timeframe: 1-week period following randomization
Intervention | Participants (Number) |
---|
TICAGRELOR | 21 |
CLOPIDOGREL | 16 |
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Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists. (NCT00391872)
Timeframe: 1-week period following randomization
Intervention | Participants (Number) |
---|
TICAGRELOR | 84 |
CLOPIDOGREL | 51 |
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Participants With MI Event
Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 504 |
CLOPIDOGREL | 593 |
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Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 1290 |
CLOPIDOGREL | 1456 |
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Participants With Non-procedural Major Bleeding
Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 235 |
CLOPIDOGREL | 180 |
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Participants With Death From Vascular Causes
Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 353 |
CLOPIDOGREL | 442 |
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Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 569 |
CLOPIDOGREL | 668 |
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Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 864 |
CLOPIDOGREL | 1014 |
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Participants With Death From Any Cause
Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: Randomization up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 399 |
CLOPIDOGREL | 506 |
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Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds. (NCT00391872)
Timeframe: First dosing up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 329 |
CLOPIDOGREL | 341 |
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Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds. (NCT00391872)
Timeframe: First dosing up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 619 |
CLOPIDOGREL | 654 |
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Participants With Any Major Bleeding Event
Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee. (NCT00391872)
Timeframe: First dosing up to 12 months
Intervention | Participants (Number) |
---|
TICAGRELOR | 961 |
CLOPIDOGREL | 929 |
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Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)
FEF25-75 is measured by Spirometry, the unit is Liter/Second. (NCT00528411)
Timeframe: Baseline
Intervention | Liter/second (Mean) |
---|
Ticagrelor | 2.88 |
Clopidogrel | 2.70 |
Placebo | 2.50 |
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Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
FRC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: Baseline
Intervention | Liter (Mean) |
---|
Ticagrelor | 2.79 |
Clopidogrel | 2.89 |
Placebo | 2.91 |
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Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
FVC is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: Baseline
Intervention | Liter (Mean) |
---|
Ticagrelor | 3.72 |
Clopidogrel | 3.73 |
Placebo | 4.03 |
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Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: Baseline
Intervention | Liter (Mean) |
---|
Ticagrelor | 2.79 |
Clopidogrel | 2.71 |
Placebo | 2.94 |
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Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle. (NCT00528411)
Timeframe: Baseline
Intervention | Percent (Mean) |
---|
Ticagrelor | 57.96 |
Clopidogrel | 61.91 |
Placebo | 59.92 |
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Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin. (NCT00528411)
Timeframe: Baseline
Intervention | Percent (Mean) |
---|
Ticagrelor | 96.59 |
Clopidogrel | 96.78 |
Placebo | 97.58 |
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Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 8 hours after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 88.31 |
Clopidogrel | 61.31 |
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Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug
IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour. (NCT00528411)
Timeframe: 4 to 72 Hours after last dose of study drug
Intervention | Percentage/Hour (Least Squares Mean) |
---|
Ticagrelor | -1.037 |
Clopidogrel | -0.482 |
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Cardiopulmonary Parameters Post 6-week Treatment: RR
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Breaths/minute (Mean) |
---|
Ticagrelor | 15.21 |
Clopidogrel | 15.10 |
Placebo | 14.91 |
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Cardiopulmonary Parameters Post 6-week Treatment: RV
RV is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liter (Mean) |
---|
Ticagrelor | 1.88 |
Clopidogrel | 1.97 |
Placebo | 1.90 |
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Cardiopulmonary Parameters Post 6-week Treatment: SpO2
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Percentage (Mean) |
---|
Ticagrelor | 97.73 |
Clopidogrel | 97.35 |
Placebo | 98.56 |
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Cardiopulmonary Parameters Post 6-week Treatment: TLC
TLC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liter (Mean) |
---|
Ticagrelor | 5.70 |
Clopidogrel | 5.85 |
Placebo | 5.96 |
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Cardiopulmonary Parameters Post 6-week Treatment: VE
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liter/minute (Mean) |
---|
Ticagrelor | 13.69 |
Clopidogrel | 13.14 |
Placebo | 11.45 |
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Cardiopulmonary Parameters Post 6-week Treatment: VT
VT is measured by Body Box Plethysmography, the unit is Liter/Minute. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liters/minute (Mean) |
---|
Ticagrelor | 0.92 |
Clopidogrel | 0.93 |
Placebo | 0.83 |
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Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 8 hours after first dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 96.99 |
Clopidogrel | 46.90 |
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Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 0.5 hours after first dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 45.39 |
Clopidogrel | 4.71 |
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Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 1 hour after first dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 86.71 |
Clopidogrel | 15.83 |
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Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 120 hours - Day 5 after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 0.0 |
Clopidogrel | 21.15 |
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Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 168 hours - Day 7 after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 0.0 |
Clopidogrel | 6.32 |
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Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 2 hours after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 91.49 |
Clopidogrel | 62.96 |
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Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 24 hours after first dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 87.29 |
Clopidogrel | 49.64 |
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Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 24 hours after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 55.18 |
Clopidogrel | 53.91 |
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Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 240 hours - Day 10 after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 1.64 |
Clopidogrel | 0.98 |
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Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 0 hour before last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 74.53 |
Clopidogrel | 51.75 |
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Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 4 hours after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 96.10 |
Clopidogrel | 61.80 |
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Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 48 hours after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 30.94 |
Clopidogrel | 45.79 |
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Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 72 hours after last dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 11.76 |
Clopidogrel | 21.09 |
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Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: 4 hours after first dose
Intervention | Percentage (Median) |
---|
Ticagrelor | 98.39 |
Clopidogrel | 40.87 |
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Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00528411)
Timeframe: At 2 hours after first dose of study drug
Intervention | Percentage (Median) |
---|
Ticagrelor | 93.15 |
Clopidogrel | 31.05 |
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Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)
DLCOSB is measured by Body Box Plethysmography, the unit is Percent. (NCT00528411)
Timeframe: Baseline
Intervention | Percent (Mean) |
---|
Ticagrelor | 17.00 |
Clopidogrel | 17.29 |
Placebo | 15.83 |
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Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute. (NCT00528411)
Timeframe: Baseline
Intervention | Breaths/minute (Mean) |
---|
Ticagrelor | 14.79 |
Clopidogrel | 14.15 |
Placebo | 15.5 |
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Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
RV is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: Baseline
Intervention | Liter (Mean) |
---|
Ticagrelor | 1.94 |
Clopidogrel | 2.01 |
Placebo | 1.91 |
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Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio. (NCT00528411)
Timeframe: Baseline
Intervention | Ratio (Mean) |
---|
Ticagrelor | 75.01 |
Clopidogrel | 73.04 |
Placebo | 73.13 |
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Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NT-proBNP is measured by clinical lab, the unit is pg/mL. (NCT00528411)
Timeframe: Baseline
Intervention | pg/ml (Mean) |
---|
Ticagrelor | 163.34 |
Clopidogrel | 185.98 |
Placebo | 145.41 |
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Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute (NCT00528411)
Timeframe: Baseline
Intervention | Liter/minute (Mean) |
---|
Ticagrelor | 12.92 |
Clopidogrel | 12.17 |
Placebo | 12.06 |
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Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
VT is measured by Body Box Plethysmography, the unit is Liter/Minute. (NCT00528411)
Timeframe: Baseline
Intervention | Liters/minute (Mean) |
---|
Ticagrelor | 0.96 |
Clopidogrel | 0.89 |
Placebo | 0.89 |
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Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
TLC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: Baseline
Intervention | Liter (Mean) |
---|
Ticagrelor | 5.78 |
Clopidogrel | 5.83 |
Placebo | 6.10 |
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Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
FEV1 is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liter (Mean) |
---|
Ticagrelor | 2.77 |
Clopidogrel | 2.74 |
Placebo | 2.95 |
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Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Ratio (Mean) |
---|
Ticagrelor | 74.71 |
Clopidogrel | 72.84 |
Placebo | 74.27 |
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Cardiopulmonary Parameters at Post 6-week Treatment: FVC
FVC is measured by Spirometry, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liter (Mean) |
---|
Ticagrelor | 3.70 |
Clopidogrel | 3.78 |
Placebo | 3.98 |
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Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
DLCOSB is measured by Body Box Plethysmography, the unit is Percent. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Percent (Mean) |
---|
Ticagrelor | 16.38 |
Clopidogrel | 16.53 |
Placebo | 16.09 |
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Cardiopulmonary Parameters Post 6-week Treatment: EF
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Percent (Mean) |
---|
Ticagrelor | 60.70 |
Clopidogrel | 62.38 |
Placebo | 60.73 |
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Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
FEF25-75 is measured by Spirometry, the unit is Liter/Second. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liter/second (Mean) |
---|
Ticagrelor | 2.77 |
Clopidogrel | 2.67 |
Placebo | 2.91 |
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Cardiopulmonary Parameters Post 6-week Treatment: FRC
FRC is measured by Body Box Plethysmography, the unit is Liter. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | Liter (Mean) |
---|
Ticagrelor | 2.73 |
Clopidogrel | 2.79 |
Placebo | 2.75 |
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Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
NT-proBNP is measured by clinical lab, the unit is pg/mL. (NCT00528411)
Timeframe: 6-week post treatment
Intervention | pg/ml (Mean) |
---|
Ticagrelor | 139.88 |
Clopidogrel | 214.43 |
Placebo | 140.68 |
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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15
IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: Day 15, 4 hrs post switching
Intervention | Percent (Least Squares Mean) |
---|
Responder: Ticagrelor | 66.7 |
Responder: Clopidogrel | 65.3 |
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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28
IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: 4 hrs post first dose on day 28
Intervention | Percent (Least Squares Mean) |
---|
Responder: Ticagrelor | 91.0 |
Responder: Clopidogrel | 61.2 |
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Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.
The secondary definition of response to treatment is IPA >50% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00642811)
Timeframe: Day 14, and day 28, 4 hours post dose
Intervention | Percent of participants (Number) |
---|
Non-responder: Ticagrelor | 81.3 |
Non-responder: Clopidogrel | 25.0 |
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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15
IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: Day 15, 4 hrs post switching
Intervention | Percent (Least Squares Mean) |
---|
Responder: Ticagrelor | 95.0 |
Responder: Clopidogrel | 48.5 |
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Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)
The primary definition of response to treatment is IPA >10% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. (NCT00642811)
Timeframe: Day 14 and Day 28, 4 Hrs Post Dose.
Intervention | Percent of Participants (Number) |
---|
Non-responder: Ticagrelor | 100 |
Non-responder: Clopidogrel | 93.8 |
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Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28
IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered. (NCT00642811)
Timeframe: 4 hrs post first dose on day 28
Intervention | Percent (Least Squares Mean) |
---|
Responder: Ticagrelor | 77.4 |
Responder: Clopidogrel | 60.8 |
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IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients
"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4
Intervention | percentage inhibition (Mean) |
---|
Arm 1 - AZD6140 45 mg bd | 56.9 |
AZD6140 90 mg bd | 66.8 |
Clopidogrel 75 mg od | 41.8 |
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AR-C124910XX (AUC0-tau) at Week 4
Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval (NCT01118325)
Timeframe: Week 4
Intervention | ng.h/mL (Geometric Mean) |
---|
AZD6140 45 mg bd in Japanese Patients | 1180 |
AZD6140 45 mg bd in Non-Japanese Patients | 954 |
AZD6140 90 mg bd in Japanese Patients | 2720 |
AZD6140 90 mg bd in Non-Japanese Patients | 3380 |
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AR-C124910XX (Cmax) at Week 4
Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX (NCT01118325)
Timeframe: Week 4
Intervention | ng/mL (Geometric Mean) |
---|
AZD6140 45 mg bd in Japanese Patients | 135 |
AZD6140 45mg bd in Non-Jpanese Patients | 101 |
AZD6140 90 mg bd in Japanese Patients | 326 |
AZD6140 90 mg bd in Non-Jpanese Patients | 381 |
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AR-C124910XX (Tmax) at Week 4
Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration (NCT01118325)
Timeframe: Week 4
Intervention | hour (Median) |
---|
AZD6140 45 mg bd in Japanese Patients | 4.0 |
AZD6140 45 mg bd in Non-Japanese Patients | 4.0 |
AZD6140 90 mg bd in Japanese Patients | 2.1 |
AZD6140 90 mg bd in Non-Japanese Patients | 2.0 |
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AZD6140 (AUC0-tau) at Week 4
Area under the plasma concentration curve of AZD6140 from time zero to dosing interval (NCT01118325)
Timeframe: Week 4
Intervention | ng.h/mL (Geometric Mean) |
---|
AZD6140 45 mg bd in Japanese Patients | 3050 |
AZD6140 45 mg bd in Non-Japanese Patients | 2930 |
AZD6140 90 mg bd in Japanese Patients | 6080 |
AZD6140 90 mg bd in Non-Japanese Patients | 10900 |
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AZD6140 (Cmax) at Week 4
Maximum plasma AZD6140 concentration (NCT01118325)
Timeframe: Week 4
Intervention | ng/mL (Geometric Mean) |
---|
AZD6140 45 mg bd in Japanese Patients | 422 |
AZD6140 45 mg bd in Non-Japanese Patients | 341 |
AZD6140 90 mg bd in Japanese Patients | 931 |
AZD6140 90 mg bd in Non-Japanese Patients | 1380 |
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AZD6140 (Tmax) at Week 4
Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration (NCT01118325)
Timeframe: Week 4
Intervention | hour (Median) |
---|
AZD6140 45 mg bd in Japanese Patients | 2.0 |
AZD6140 45 mg bd in Non-Japanese Patients | 4.0 |
AZD6140 90 mg bd in Japanese Patients | 2.0 |
AZD6140 90 mg bd in Non-Japanese Patients | 4.0 |
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Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients
"Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4
Intervention | percentage inhibition (Mean) |
---|
AZD6140 45 mg bd | 64.5 |
AZD6140 90 mg bd | 73.0 |
Clopidogrel 75 mg od | 38.9 |
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IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients
"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4
Intervention | percentage inhibition (Mean) |
---|
AZD6140 45 mg bd | 46.2 |
AZD6140 90 mg bd | 59.1 |
Clopidogrel 75 mg od | 38.0 |
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IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients
"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4
Intervention | percentage inhibition (Mean) |
---|
AZD6140 45 mg bd | 67.3 |
AZD6140 90 mg bd | 73.2 |
Clopidogrel 75 mg od | 43.7 |
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IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients
"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit." (NCT01118325)
Timeframe: Week 4
Intervention | percentage inhibition (Mean) |
---|
AZD6140 45 mg bd | 62.7 |
AZD6140 90 mg bd | 68.6 |
Clopidogrel 75 mg od | 42.5 |
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Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization
Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization (NCT01225562)
Timeframe: Randomization up to 47 months
Intervention | Percentage of Patients (Number) |
---|
Ticagrelor 90 mg | 2.9 |
Ticagrelor 60 mg | 2.9 |
Placebo | 3.4 |
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Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization
Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization (NCT01225562)
Timeframe: Randomization up to 47 months
Intervention | Percentage of Patients (Number) |
---|
Ticagrelor 90 mg | 5.1 |
Ticagrelor 60 mg | 4.7 |
Placebo | 5.2 |
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Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients
A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug (NCT01225562)
Timeframe: First dosing up to 48 months
Intervention | Percentage of Patients (Number) |
---|
Ticagrelor 90 mg | 2.6 |
Ticagrelor 60 mg | 2.3 |
Placebo | 1.1 |
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Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization
Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization (NCT01225562)
Timeframe: Randomization up to 47 months
Intervention | Percentage of Patients (Number) |
---|
Ticagrelor 90 mg | 7.8 |
Ticagrelor 60 mg | 7.8 |
Placebo | 9.0 |
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Major Adverse Cardiac Events (MACE)
Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to 12 months
Intervention | Percent probability (Number) |
---|
Ticagrelor (AZD6140) | 10.2 |
Clopidogrel | 8.1 |
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Composite of All-cause Mortality, MI or Stroke
Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to 12 months
Intervention | Percent probability (Number) |
---|
Ticagrelor (AZD6140) | 10.5 |
Clopidogrel | 8.1 |
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Major Bleeding
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to12 months
Intervention | Percent probability (Number) |
---|
Ticagrelor (AZD6140) | 11.2 |
Clopidogrel | 8.4 |
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Major and Minor Bleeding
Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method. (NCT01294462)
Timeframe: Ongoing up to12 months
Intervention | Percent probability (Number) |
---|
Ticagrelor (AZD6140) | 26.8 |
Clopidogrel | 16.2 |
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Major Bleeds Within 48 Hours
non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds (NCT01347580)
Timeframe: within 48 hours of first dose
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 16 |
In-hospital Ticagrelor | 15 |
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Major Bleeds After 48 Hours
non CABG related bleeds (PLATO definition) include life threatening and other major bleedings (NCT01347580)
Timeframe: after 48hours post-first dose
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 11 |
In-hospital Ticagrelor | 11 |
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Definite Stent Thrombosis
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint (NCT01347580)
Timeframe: during 30 days of treatment
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 2 |
In-hospital Ticagrelor | 11 |
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2nd Composite Clinical Endpoint
Death/MI/urgent revascularization. Adjudicated events except death (NCT01347580)
Timeframe: within 30 days of study
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 39 |
In-hospital Ticagrelor | 34 |
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1st Composite Clinical Endpoint
death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death (NCT01347580)
Timeframe: during the 30 days of treatment
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 41 |
In-hospital Ticagrelor | 42 |
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Minor and Major Bleeds After 48 Hours
non CABG related bleeds (PLATO definition) (NCT01347580)
Timeframe: after 48 hours post first dose
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 18 |
In-hospital Ticagrelor | 16 |
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Minor and Major Bleedings Within 48 Hours
non CABG related bleeds (PLATO definition) (NCT01347580)
Timeframe: within 48 hours of first dose
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 24 |
In-hospital Ticagrelor | 24 |
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TIMI Flow Grade 3 Post -PCI
TIMI) flow grade 3 is complete perfusion post-PCI. (NCT01347580)
Timeframe: at coroangiography post-PCI
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 625 |
In-hospital Ticagrelor | 630 |
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Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI
Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention. (NCT01347580)
Timeframe: during PCI
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 78 |
In-hospital Ticagrelor | 100 |
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Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)
(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion. (NCT01347580)
Timeframe: At initial angiography, pre PCI
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 143 |
In-hospital Ticagrelor | 145 |
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ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)
ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution. (NCT01347580)
Timeframe: Between baseline and PCI
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 102 |
In-hospital Ticagrelor | 102 |
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ST Segment Elevation Resolution Post-PCI >= 70%
ST segment elevation resolution post PCI >=70% is defined as complete resolution (NCT01347580)
Timeframe: Between baseline and ECG 60 mn post-PCI
Intervention | patients (Number) |
---|
Pre-hospital Ticagrelor | 410 |
In-hospital Ticagrelor | 390 |
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Any Bleeding Event
"Bleeding classified by the TIMI hemorrhage classification scheme:~Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL~Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL" (NCT01515345)
Timeframe: 30days
Intervention | participants (Number) |
---|
Standard Therapy | 17 |
Individualized Therapy | 9 |
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Probable Stent Thrombosis
"Probable stent thrombosis is considered to have occurred in case of~any unexplained death within the first 30 days.~any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure" (NCT01515345)
Timeframe: 30days
Intervention | participants (Number) |
---|
Standard Therapy | 2 |
Individualized Therapy | 0 |
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Definite Stent Thrombosis
"The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis" (NCT01515345)
Timeframe: 30 days
Intervention | participants (Number) |
---|
Standard Therapy | 1 |
Individualized Therapy | 0 |
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Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD. (NCT01523366)
Timeframe: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose
Intervention | ng/mL (Geometric Mean) |
---|
| Baseline (0 hours - pre-dose) | 0,.5 hours after the loading dose | 2 hours after the loading dose - Period 2 N=18 | 8 hours after the loading dose | 0 hours after multiple doses | 2 hours after multiple doses | 8 hours after multiple doses | End of dosing interval on Day 8 - Period 1 N=17 |
---|
Ticagrelor (Treatment Period 1) | 1.2 | 206.7 | 665.4 | 376.9 | 248.8 | 609.3 | 340.4 | 283.3 |
,Ticagrelor (Treatment Period 2) | 1.1 | 118.6 | 758.5 | 479.6 | 220.1 | 466.5 | 305.2 | 200.7 |
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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8
The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value (NCT01523366)
Timeframe: At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8
Intervention | PRU (Least Squares Mean) |
---|
| 2 hours on day 7 | 8 hours on Day 7 -ticagrelor N=36 clopidogrel N=33 | End of Dosing Interval on Day 8 - N's per 8 hours |
---|
Clopidogrel Arm | 179.0 | 178.9 | 182.1 |
,Ticagrelor Arm | 28.5 | 38.7 | 51.5 |
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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose
Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value (NCT01523366)
Timeframe: At 0.5 and 8 hours after the loading dose
Intervention | PRU (Least Squares Mean) |
---|
| 0.5 hours | 8 hours |
---|
Clopidogrel Arm | 269.8 | 202.8 |
,Ticagrelor Arm | 134.6 | 34.0 |
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AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
The SD is a statistic using the log-transformed data and is not the geometric SD. (NCT01523366)
Timeframe: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose
Intervention | ng/mL (Geometric Mean) |
---|
| Baseline (0 hours - pre-dose) | 0,.5 hours after the loading dose | 2 hours after the loading dose - Period 2 N=18 | 8 hours after the loading dose | 0 hours after multiple doses | 2 hours after multiple doses | 8 hours after multiple doses | End of dosing interval on Day 8 - Period 1 N=17 |
---|
Ticagrelor (Treatment Period 1) | 1.1 | 13.6 | 153.2 | 113.8 | 113.3 | 183.4 | 132.8 | 124.8 |
,Ticagrelor (Treatment Period 2) | 1.0 | 9.3 | 170.8 | 97.7 | 62.7 | 97.4 | 83.5 | 57.7 |
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Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value (NCT01523366)
Timeframe: At 2 hours after the loading dose
Intervention | PRU (Least Squares Mean) |
---|
Ticagrelor Arm | 34.2 |
Clopidogrel Arm | 201.4 |
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Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
(NCT01523392)
Timeframe: At 2 hours after the loading dose
Intervention | PRU (Least Squares Mean) |
---|
Ticagrelor | 27.6 |
Clopidogrel | 211.2 |
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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8
(NCT01523392)
Timeframe: At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8
Intervention | PRU (Least Squares Mean) |
---|
| 2 hours on Day 7 (N=27 for clopidogrel) | 8 hours on Day 7 | End of dosing interval on Day 8 |
---|
Clopidogrel | 157.8 | 146.5 | 172.7 |
,Ticagrelor | 22.9 | 28.5 | 39.3 |
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Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose
(NCT01523392)
Timeframe: At 0.5 hour and 8 hours after the loading dose
Intervention | PRU (Least Squares Mean) |
---|
| 0.5 hours | 8 hours (N=28 ticagrelor, N=27 clopidogrel) |
---|
Clopidogrel | 270.1 | 192.6 |
,Ticagrelor | 166.3 | 27.2 |
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AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
The standard deviation (SD) is the geometric SD (NCT01523392)
Timeframe: Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose
Intervention | ng/mL (Geometric Mean) |
---|
| Baseline (0 pre-dose hours) | 0.5 hours after the loading dose | 2 hours after the loading dose | 8 hours after the loading dose - Period 1 N=19 | 0 hours after multiple doses - Period 1 N=18 | 2 hours after multiple doses - Period 1 N=18 | 8 hours after multiple doses - Period 1 N=18 | End of dosing interval on Day 8 - Period 1 N=18 |
---|
Ticagrelor (Treatment Period 1) | 1.0 | 9.8 | 222.6 | 119.0 | 93.2 | 136.7 | 89.8 | 140.8 |
,Ticagrelor (Treatment Period 2) | 1.0 | 2.3 | 150.9 | 54.8 | 74.5 | 172.3 | 112.6 | 110.3 |
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Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
The standard deviation (SD) is the geometric SD (NCT01523392)
Timeframe: Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose
Intervention | ng/mL (Geometric Mean) |
---|
| Baseline (0 pre-dose hours) | 0.5 hours after the loading dose | 2 hours after the loading dose | 8 hours after the loading dose - Period 1 N=19 | 0 hours after multiple doses - Period 1 N=18 | 2 hours after multiple doses - Period 1 N=18 | 8 hours after multiple doses - Period 1 N=18 | End of dosing interval on Day 8 - Period 1 N=18 |
---|
Ticagrelor (Treatment Period 1) | 1.0 | 206.6 | 1167.3 | 395.9 | 168.4 | 324.6 | 179.2 | 284.9 |
,Ticagrelor (Treatment Period 2) | 1.2 | 33.7 | 756.9 | 141.9 | 187.4 | 608.8 | 311.3 | 295.7 |
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Pharmacodynamic Measurement
"Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test.~* Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section." (NCT01526577)
Timeframe: 1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study
Intervention | percentage of platelet inhibition (Number) |
---|
LC23-1306 | 70 |
Placebo | 30 |
Ticagrelor | 91.9 |
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P2Y12 Reaction Units
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition. (NCT01587651)
Timeframe: 7 days after first randomized dose
Intervention | PRU (P2Y12 Reaction Units) (Least Squares Mean) |
---|
Prasugrel Combined Groups | 95.0 |
Ticagrelor | 49.0 |
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P2Y12 Reaction Units
P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment (NCT01587651)
Timeframe: 2, 4, 24, 48 hours after first randomized dose
Intervention | PRU (Least Squares Mean) |
---|
| 2 hours | 4 hours | 24 hours | 48 hours |
---|
Prasugrel Combined Groups | 33.7 | 41.1 | 126.8 | 159.3 |
,Prasugrel Loading Dose | 22.1 | 24.1 | 81.6 | 118.3 |
,Prasugrel Maintenance Dose | 44.8 | 57.0 | 167.8 | 199.0 |
,Ticagrelor | 28.9 | 29.3 | 47.6 | 38.6 |
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Percentage of Subjects With High On-treatment Platelet Reactivity
"Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment.~A poor response of the platelets to drug, called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events" (NCT01587651)
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dose
Intervention | percentage of subjects (Number) |
---|
| >= 208 PRU 2 hours post dose | >= 208 PRU 4 hours post dose | >= 208 PRU 24 hours post dose | >= 208 PRU 48 hours post dose | >= 208 PRU 7 days post dose | >= 230 PRU by VerifyNow P2Y12 2 hours post dose | >= 230 PRU by VerifyNow P2Y12 4 hours post dose | >= 230 PRU by VerifyNow P2Y12 24 hours post dose | >= 230 PRU by VerifyNow P2Y12 48 hours post dose | >= 230 PRU by VerifyNow P2Y12 7 days post dose | >50% PRI by VASP assay 2 hours post dose | >50% PRI by VASP assay 4 hours post dose | >50% PRI by VASP assay 24 hours post dose | >50% PRI by VASP assay 48 hours post dose | >50% PRI by VASP assay 7 days post dose |
---|
Prasugrel Combined Groups | 0 | 0 | 17.5 | 30.2 | 1.5 | 0 | 0 | 14.3 | 22.2 | 1.5 | 3.5 | 1.8 | 21.3 | 45 | 15.5 |
,Prasugrel Loading Dose | 0 | 0 | 3.3 | 16.1 | 3.2 | 0 | 0 | 3.3 | 6.5 | 3.2 | 3.6 | 0 | 3.4 | 13.8 | 23.1 |
,Prasugrel Maintenance Dose | 0 | 0 | 37.5 | 43.8 | 0 | 0 | 0 | 24.2 | 37.5 | 0 | 3.4 | 3.4 | 37.5 | 74.2 | 9.4 |
,Ticagrelor | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 3 | 3.3 | 3.3 | 12.9 | 6.3 | 3.4 |
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Platelet Reactivity Index
"Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.~The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation." (NCT01587651)
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dose
Intervention | percentage PRI (Least Squares Mean) |
---|
| 2 hours post-dose | 4 hours post-dose | 24 hours post-dose | 48 hours post-dose | 7 days post-dose |
---|
Prasugrel Combined Groups | 18.2 | 16.3 | 34.3 | 48.1 | 33.5 |
,Prasugrel Loading Dose | 15.8 | 11.4 | 24.2 | 38.0 | 38.8 |
,Prasugrel Maintenance Dose | 20.4 | 20.9 | 43.7 | 57.7 | 29.1 |
,Ticagrelor | 13.2 | 14.3 | 19.1 | 18.7 | 19.8 |
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PRU Percent Inhibition (Calculated)
"Analysis of Mean Calculated Percent Inhibition by time point~Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU - PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t." (NCT01587651)
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dose
Intervention | Percent Inhibition (Least Squares Mean) |
---|
| 2 hours post-dose | 4 hours post dose | 24 hours post dose | 48 hours post dose | 7 days psot dose |
---|
Prasugrel Combined Groups | 88.22 | 85.06 | 53.63 | 41.59 | 64.97 |
,Prasugrel Loading Dose | 92.55 | 91.36 | 71.40 | 57.98 | 64.97 |
,Prasugrel Maintenance Dose | 84.15 | 79.35 | 38.01 | 26.20 | 64.97 |
,Ticagrelor | 89.73 | 89.26 | 81.86 | 85.06 | 80.69 |
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PRU Percent Inhibition (Device-reported)
"PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment~VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide." (NCT01587651)
Timeframe: 2, 4, 24, 48 hours, 7 days after first randomized dose
Intervention | percent inhibition (Least Squares Mean) |
---|
| 2 hours post-dose | 4 hours post-dose | 24 hours post-dose | 48 hours post-dose | 7 days post-dose |
---|
Prasugrel Combined Groups | 87.8 | 84.9 | 54.1 | 42.3 | 65.5 |
,Prasugrel Loading Dose | 91.4 | 90.2 | 69.6 | 58.3 | 65.6 |
,Prasugrel Maintenance Dose | 84.3 | 79.8 | 40.0 | 26.8 | 65.4 |
,Ticagrelor | 89.2 | 89.6 | 81.9 | 85.8 | 81.0 |
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All Death or Myocardial Infarction Rate
See description of individual events. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 3.2 |
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All Death Rate
All death includes cardiac death and non-cardiac death. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 2.3 |
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ARC ST Rate in PLATINUM-like Population.
Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%). (NCT01589978)
Timeframe: Annually through 5 years
Intervention | percentage of participants (Number) |
---|
PROMUS Element Overall Population | 0.0023 |
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Cardiac Death or Myocardial Infarction (MI) Rate
See individual descriptions of events. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 2.3 |
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Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%) (NCT01589978)
Timeframe: 12 months
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 1.78 |
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Cardiac Death Rate
Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 1.4 |
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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days) (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 0.7 |
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Major Adverse Cardiac Event Rate (MACE)
Composite of cardiac death, myocardial infarction, and target vessel revascularization (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 6.9 |
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Myocardial Infarction (MI) Rate
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 1.1 |
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Non-cardiac Death Rate
"Non-cardiac death is defined as death not due to cardiac causes.~Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded." (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 0.9 |
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Target Vessel Failure (TVF) Rate
"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF." (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 6.7 |
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Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%) (NCT01589978)
Timeframe: 12 Months
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 3.26 |
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Target Vessel Revascularization (TVR) Rate
Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel. (NCT01589978)
Timeframe: ≤24 hours, 30 days, 180 days, annually through 5 years
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 5.6 |
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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%) (NCT01589978)
Timeframe: 12 months
Intervention | percentage of patients (Number) |
---|
PROMUS Element | 0.3 |
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Total Dabigatran: Maximum Measured Concentration (Cmax)
Maximum measured concentration of total dabigatran in plasma, per period. (NCT01595854)
Timeframe: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Intervention | ng/mL (Geometric Mean) |
---|
Dabi 75 mg | 31.47 |
Dabi + Ticagrelor LD | 61.30 |
Dabi + Ticagrelor MD | 49.11 |
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Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran. (NCT01595854)
Timeframe: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Intervention | ng*h/mL (Geometric Mean) |
---|
Dabi 75 mg | 281.05 |
Dabi + Ticagrelor LD | 485.48 |
Dabi + Ticagrelor MD | 410.46 |
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Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™
Participants with low (<150) baseline PRU values were excluded. (NCT01603082)
Timeframe: 0.5 hours, end of PCI, and 8 hours after the loading dose
Intervention | PRU (Mean) |
---|
| 0.5 hours | 8 hours | End of PCI (n=41 for ticagrelor) |
---|
Clopidogrel | 297.7 | 202.3 | 307.8 |
,Ticagrelor | 277.3 | 43.8 | 264.2 |
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Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™
Participants with low (<150) baseline PRU values were excluded. (NCT01603082)
Timeframe: 2 hours after the loading dose
Intervention | PRU (Mean) |
---|
Ticagrelor | 98.4 |
Clopidogrel | 257.5 |
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Platelet Reactivity
Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition (NCT01642238)
Timeframe: Pre-treatment baseline
Intervention | percent inhibition (Number) |
---|
Ticagrelor + ASA + Bivalirudin | 2.9 |
Clopidogrel + ASA + Bivalirudin | 3.7 |
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Blood Thrombogenicity
Coagulation times, assessed using the ROTEM thromboelastometry (NCT01642238)
Timeframe: 24-hours post-treatment
Intervention | seconds (Mean) |
---|
Ticagrelor + ASA + Bivalirudin | 56.1 |
Clopidogrel + ASA + Bivalirudin | 54.3 |
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Platelet Reactivity
Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition (NCT01642238)
Timeframe: 24-hours post-treatment
Intervention | percent inhibition (Mean) |
---|
Ticagrelor + ASA + Bivalirudin | 67.4 |
Clopidogrel + ASA + Bivalirudin | 53.4 |
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Platelet Reactivity
Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition (NCT01642238)
Timeframe: 1 hr post-treatment
Intervention | percent inhibition (Mean) |
---|
Ticagrelor + ASA + Bivalirudin | 69.4 |
Clopidogrel + ASA + Bivalirudin | 20.1 |
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Blood Thrombogenicity
Coagulation times, assessed using the ROTEM thromboelastometry (NCT01642238)
Timeframe: Pre-treatment baseline
Intervention | seconds (Mean) |
---|
Ticagrelor + ASA + Bivalirudin | 53.1 |
Clopidogrel + ASA + Bivalirudin | 51.1 |
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Blood Thrombogenicity
Coagulation times, assessed using the ROTEM thromboelastometry (NCT01642238)
Timeframe: 1 hr post-treatment
Intervention | seconds (Mean) |
---|
Ticagrelor + ASA + Bivalirudin | 163.1 |
Clopidogrel + ASA + Bivalirudin | 174.0 |
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Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)
The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment (NCT01731041)
Timeframe: 4 hours
Intervention | PRI% (Least Squares Mean) |
---|
Ticagrelor 180mg | 17.87 |
Ticagrelor 90mg | 23.4 |
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P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12
Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system. (NCT01731041)
Timeframe: 4 hours
Intervention | PRU (Least Squares Mean) |
---|
Ticagrelor 180mg | 16.8 |
Ticagrelor 90mg | 31.4 |
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MI
Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 349 |
Clopidogrel 75 mg od | 334 |
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Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])
Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 1211 |
Clopidogrel 75 mg od | 1250 |
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Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke
Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg bd | 751 |
Clopidogrel 75 mg od | 740 |
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Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)
Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 766 |
Clopidogrel 75 mg od | 759 |
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Composite of CV Death, MI, Ischemic Stroke, and ALI
Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 839 |
Clopidogrel 75 mg od | 833 |
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CV Death
Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 363 |
Clopidogrel 75 mg od | 343 |
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All-cause Mortality
Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 628 |
Clopidogrel 75 mg od | 635 |
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Major Amputation Caused by PAD
Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 100 |
Clopidogrel 75 mg od | 116 |
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Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)
Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 1119 |
Clopidogrel 75 mg od | 1140 |
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Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)
Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 1183 |
Clopidogrel 75 mg od | 1199 |
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Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)
Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 983 |
Clopidogrel 75 mg od | 992 |
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Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)
Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 789 |
Clopidogrel 75 mg od | 786 |
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Non-CV Death
Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 250 |
Clopidogrel 75 mg od | 272 |
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PLATO Major Bleeding Events
Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 206 |
Clopidogrel 75 mg od | 188 |
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TIMI Major Bleeding Events
Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 113 |
Clopidogrel 75 mg od | 109 |
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Changes in Rutherford Classification
"Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.~Category 0 - Asymptomatic Category 1 - Mild claudication Category 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Category 3 - Severe claudication Category 4 - Rest pain Category 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 - Severe ischemic ulcers or frank gangrene" (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
| Category 0 - End of treatment | Category 1/2 - End of treatment | Category 3 - End of treatment | Category 4 - End of treatment | Category 5 - End of treatment | Category 6 - End of treatment | Missing - End of treatment |
---|
Clopidogrel - Cat 0 | 743 | 230 | 56 | 9 | 2 | 2 | 250 |
,Clopidogrel - Cat 1/2 | 723 | 1956 | 311 | 15 | 6 | 1 | 724 |
,Clopidogrel - Cat 3 | 198 | 557 | 450 | 23 | 6 | 4 | 370 |
,Clopidogrel - Cat 4 | 33 | 33 | 38 | 23 | 4 | 1 | 60 |
,Clopidogrel - Cat 5 | 13 | 18 | 12 | 11 | 12 | 0 | 34 |
,Clopidogrel - Cat 6 | 6 | 3 | 3 | 1 | 1 | 0 | 11 |
,Ticagrelor - Cat 0 | 775 | 227 | 45 | 7 | 5 | 2 | 248 |
,Ticagrelor - Cat 3 | 171 | 560 | 469 | 12 | 3 | 2 | 403 |
,Ticagrelor - Cat 4 | 15 | 41 | 39 | 31 | 1 | 0 | 59 |
,Ticagrelor - Cat 5 | 23 | 23 | 13 | 4 | 11 | 0 | 33 |
,Ticagrelor - Cat 6 | 3 | 5 | 6 | 3 | 0 | 2 | 14 |
,Ticagrelor - Stage II | 683 | 1948 | 269 | 24 | 4 | 3 | 743 |
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TIMI Major or Minor Bleeding Events
Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 193 |
Clopidogrel 75 mg od | 175 |
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Change in ABI/TBI From Baseline
"Change in ankle brachial index (ABI) / toe brachial index (TBI).~Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):~Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4~Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:~Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg" (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Change in ABI/TBI (Mean) |
---|
| ABI - 6 months N = 6184(Tica), 6319(Clopi) | ABI - End of treatment N = 4951(Tica), 5073(Clopi) | TBI - 6 months N = 55(Tica), 48(Clopi) | TBI - End of treatment N = 36(Tica), 21(Clopi) |
---|
Clopidogrel 75 mg od | 0.011 | 0.016 | 0.036 | -0.065 |
,Ticagrelor 90 mg bd | 0.016 | 0.022 | 0.050 | 0.059 |
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Lower Extremity Revascularization
Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 846 |
Clopidogrel 75 mg od | 892 |
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Changes in Fontaine Stage
"Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.~Stage I - Asymptomatic Stage IIa - Intermittent claudication after more than 200 meters of pain free walking Stage IIb - Intermittent claudication after less than 200 meters of walking Stage III - Rest pain Stage IV - Ischemic ulcers or gangrene" (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
| Stage I - End of treatment | Stage IIa - End of treatment | Stage IIb - End of treatment | Stage III - End of treatment | Stage IV - End of treatment | Missing - End of treatment |
---|
Clopidogrel - Stage I | 743 | 230 | 56 | 9 | 4 | 250 |
,Clopidogrel - Stage IIa | 723 | 1956 | 311 | 15 | 7 | 724 |
,Clopidogrel - Stage IIb | 198 | 557 | 450 | 23 | 10 | 370 |
,Clopidogrel - Stage III | 33 | 33 | 38 | 23 | 5 | 60 |
,Clopidogrel - Stage IV | 19 | 21 | 15 | 12 | 13 | 45 |
,Ticagrelor - Stage I | 775 | 227 | 45 | 7 | 7 | 248 |
,Ticagrelor - Stage IIa | 683 | 1948 | 269 | 24 | 7 | 743 |
,Ticagrelor - Stage IIb | 171 | 560 | 469 | 12 | 5 | 403 |
,Ticagrelor - Stage III | 15 | 41 | 39 | 31 | 1 | 59 |
,Ticagrelor - Stage IV | 26 | 28 | 19 | 7 | 13 | 47 |
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ALI
Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 117 |
Clopidogrel 75 mg od | 115 |
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Any Amputation Caused by PAD
Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date) (NCT01732822)
Timeframe: From randomization to PACD, an average of 2.5 years
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 179 |
Clopidogrel 75 mg od | 208 |
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Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event
Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug) (NCT01732822)
Timeframe: From the date of first dose and up to and including 7 days following the date of last dose of study drug
Intervention | Participant (Number) |
---|
Ticagrelor 90 mg bd | 168 |
Clopidogrel 75 mg od | 112 |
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Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss). (NCT01734772)
Timeframe: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
Intervention | ng/mL (Geometric Mean) |
---|
Dabigratan Etexilate 110mg Bid Alone - Part 1 | 83.6 |
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1 | 136 |
Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1 | 106 |
Dabigratan Etexilate 110mg Bid Alone - Part 2 | 97.6 |
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2 | 121 |
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Thrombolysis in Myocardial Infarction Major or Minor Bleeding
Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding (NCT01742117)
Timeframe: Approximately 3 years after percutaneous coronary intervention (PCI)
Intervention | Participants (Count of Participants) |
---|
Genotype-Guided Therapy | 54 |
Conventional Therapy | 53 |
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Thrombolysis in Myocardial Infarction Major or Minor Bleeding in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.
Number of subjects that experienced thrombolysis in myocardial infarction major or minor bleeding in subjects identified as CYP2C19 LOF carriers by TaqMan (NCT01742117)
Timeframe: 1 year after percutaneous coronary intervention (PCI)
Intervention | Participants (Count of Participants) |
---|
Genotype-Guided Therapy | 16 |
Conventional Therapy | 14 |
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Occurrence of the a Major Adverse Cardiovascular Event
Number of subjects to experience a major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis. (NCT01742117)
Timeframe: Approximately 3 years after percutaneous coronary intervention (PCI)
Intervention | Participants (Count of Participants) |
---|
Genotype-Guided Therapy | 262 |
Conventional Therapy | 269 |
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Occurrence of the a Major Adverse Cardiovascular Event in Subjects Identified as CPY2C19 LOF Carriers by TaqMan.
Number of subjects who experienced major adverse cardiovascular event as defined as cardiovascular death, myocardial infarction, stroke, severe recurrent ischemia, and stent thrombosis in subjects identified as CPY2C19 LOF carriers by TaqMan. (NCT01742117)
Timeframe: 1 year after percutaneous coronary intervention (PCI)
Intervention | Participants (Count of Participants) |
---|
Genotype-Guided Therapy | 35 |
Conventional Therapy | 54 |
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Extent of Aggregation Response During Ticagrelor Treatment
"Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.~A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.~Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)." (NCT01766466)
Timeframe: Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion
Intervention | percentage of platelet reactivity (PR) (Mean) |
---|
| Reference 5.25 hours - PR | 2.25 hours - PR | 2.5 hours - PR | 2.75 hours - PR | 3 hours - PR | 4 hours - PR |
---|
All Patients | 4 | 12 | 19 | 10 | 7.1 | 4.6 |
,Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion | 5.8 | 13 | 16 | 12 | 10 | 6.7 |
,Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion | 2.2 | 11 | 21 | 7.8 | 4.5 | 2.5 |
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Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor
"A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.~Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)." (NCT01766466)
Timeframe: Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion
Intervention | percentage of platelet reactivity (PR) (Mean) |
---|
| 1.0 hours - PR | 2.0 hours - PR |
---|
All Patients | 1.5 | 1.3 |
,Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion | 1.5 | 1.5 |
,Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion | 1.5 | 1.2 |
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Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)
A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). (NCT01766466)
Timeframe: Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)
Intervention | percentage of platelet reactivity (PR) (Mean) |
---|
| Reference 0.5/1.25 hours - PR | 1.75 hours - PR | 2.0 hours - PR |
---|
All Patients | 1.7 | 2.2 | 2.3 |
,Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion | 2 | 2.3 | 3.5 |
,Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion | 1.3 | 2 | 1.2 |
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Number of Participants With a Stroke
(NCT01813435)
Timeframe: 2 year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 80 |
Reference Treatment Strategy | 82 |
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Number of Participants With New Q-wave Myocardial Infarction
(NCT01813435)
Timeframe: 2-year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 83 |
Reference Treatment Strategy | 103 |
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Number of Participants With Myocardial Infarction
(NCT01813435)
Timeframe: 2 year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 248 |
Reference Treatment Strategy | 250 |
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Number of Participants With All-cause Mortality
(NCT01813435)
Timeframe: 2-year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 224 |
Reference Treatment Strategy | 253 |
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Number of Participants With a Myocardial Revascularisation
(NCT01813435)
Timeframe: 2 year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 739 |
Reference Treatment Strategy | 793 |
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Number of Participants With a Definite Stent Thrombosis
(NCT01813435)
Timeframe: 2 year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 64 |
Reference Treatment Strategy | 64 |
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Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction
shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded (NCT01813435)
Timeframe: 2-year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 362 |
Reference Treatment Strategy | 416 |
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Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)
Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation. (NCT01813435)
Timeframe: 2 year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 304 |
Reference Treatment Strategy | 349 |
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Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding
"BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.~Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with:~Type 3a:~Overt bleeding + Hb drop of 3 to < 5 g/dL (provided Hb drop is related to bleed)~Any transfusion with overt bleeding~Type 3b:~Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed)~Cardiac tamponade~Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)~Bleeding requiring intravenous vasoactive agents~Type 3c:~Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision. Type 5: Fatal bleeding~Type 5a:~• Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious~Type 5b:~Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation" (NCT01813435)
Timeframe: 2 year
Intervention | Participants (Count of Participants) |
---|
Experimental Treatment Strategy | 163 |
Reference Treatment Strategy | 169 |
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Platelet Reactivity Index (PRI)
Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay. (NCT01823510)
Timeframe: up to 7 days
Intervention | percentage of baseline PRI (Mean) |
---|
| 2 hour post-loading dose | 6 hour post-loading dose | 5-7 days of maintenance dosing |
---|
Clopidogrel + Aspirin | 85.8 | 82.5 | 68.4 |
,Ticagrelor + Aspirin | 21.8 | 17.8 | 17.2 |
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Platelet Reactivity
Platelet reactivity by Multiplate Analyzer (NCT01823510)
Timeframe: up to 7 days
Intervention | percentage of baseline Unit (Mean) |
---|
| 2 hour post-loading dose | 6 hour post-loading dose | 5-7 days of maintenance dosing |
---|
Clopidogrel + Aspirin | 54.5 | 43.6 | 45.5 |
,Ticagrelor + Aspirin | 20.5 | 20.6 | 24.2 |
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P2Y12 Reaction Unit (PRU)
Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow (NCT01823510)
Timeframe: up to 7 days
Intervention | percentage of baseline PRU (Mean) |
---|
| 2 hour post-loading dose | 6 hour post-loading dose | 5-7 days of maintenance dosing |
---|
Clopidogrel + Aspirin | 77.8 | 66.8 | 62.7 |
,Ticagrelor + Aspirin | 14.8 | 8.2 | 14.5 |
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Percentage of Participants With Stroke
The percentage of participants with the first occurrence of Stroke were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 694, 704, 695) | End of DAPT-1 Month (n= 0, 108, 112) | End of DAPT-6 Month (n= 0, 248, 243) | End of DAPT-12 Month (n= 0, 348, 340) |
---|
Rivaroxaban 15 mg | 1.2 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 1.4 | 1.9 | 2.4 | 0.6 |
,Vitamin K Antagonist (VKA) | 1 | 2.7 | 0 | 1.2 |
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Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 696, 706, 697) | End of DAPT-1 Month (n= 0, 108, 113) | End of DAPT-6 Month (n= 0, 248, 243) | End of DAPT-12 Month (n= 0, 350, 341) |
---|
Rivaroxaban 15 mg | 1.0 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 1.0 | 0.9 | 0.4 | 1.4 |
,Vitamin K Antagonist (VKA) | 1.9 | 1.8 | 2.5 | 1.5 |
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Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 696, 706, 697) | End of DAPT-1 Month (n= 0, 108, 113) | End of DAPT-6 Month (n= 0, 248, 243) | End of DAPT-12 Month (n= 0, 350, 341) |
---|
Rivaroxaban 15 mg | 13.4 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 14.4 | 16.7 | 12.9 | 14.9 |
,Vitamin K Antagonist (VKA) | 19.9 | 18.6 | 23 | 18.2 |
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Percentage of Participants With Cardiovascular Death
The percentage of participants with the first occurrence of cardiovascular death were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 694, 704, 695) | End of DAPT-1 Month (n= 0, 108, 112) | End of DAPT-6 Month (n= 0, 248, 243) | End of DAPT-12 Month (n= 0, 348, 340) |
---|
Rivaroxaban 15 mg | 2.2 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 2 | 1.9 | 2.4 | 1.7 |
,Vitamin K Antagonist (VKA) | 1.6 | 1.8 | 1.6 | 1.5 |
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Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 694, 704, 695) | End of DAPT-1 Month (n= 0, 108, 112) | End of DAPT-6 Month (n= 0, 248, 243) | End of DAPT-12 Month (n= 0, 348, 340) |
---|
Rivaroxaban 15 mg | 5.9 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 5.1 | 5.6 | 6.5 | 4 |
,Vitamin K Antagonist (VKA) | 5.2 | 4.5 | 3.7 | 6.5 |
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Percentage of Participants With Clinically Significant Bleeding
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. (NCT01830543)
Timeframe: Up to Month 12
Intervention | percentage of participants (Number) |
---|
Rivaroxaban 15 mg | 15.7 |
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 16.6 |
Vitamin K Antagonist (VKA) | 24.0 |
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Percentage of Participants With Myocardial Infarction
The percentage of participants with the first occurrence of Myocardial Infarction were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 694, 704, 695) | End of DAPT-1 Month (n= 0, 108, 112) | End of DAPT-6 Month (n= 0, 248, 243) | End of DAPT-12 Month (n= 0, 348, 340) |
---|
Rivaroxaban 15 mg | 2.7 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 2.4 | 2.8 | 2.8 | 2 |
,Vitamin K Antagonist (VKA) | 3 | 0.9 | 2.5 | 4.1 |
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Percentage of Participants With Stent Thrombosis
The percentage of participants with the first occurrence of stent thrombosis were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 694, 704, 695) | End of DAPT-1 Month (n= 0, 108, 112) | End of DAPT-6 Month (n= 0, 248, 243) | End of DAPT-12 Month (n= 0, 348, 340) |
---|
Rivaroxaban 15 mg | 0.7 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 0.9 | 1.9 | 1.6 | 0 |
,Vitamin K Antagonist (VKA) | 0.6 | 0.9 | 0.4 | 0.6 |
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Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent). (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12
Intervention | percentage of participants (Number) |
---|
| Up to Month 12 (n= 696, 706, 697) | End of DAPT-1 Month (n= 0, 108,113) | End of DAPT-6 Month (n= 0, 248,243) | End of DAPT-12 Month (n= 0, 350,341) |
---|
Rivaroxaban 15 mg | 2.0 | NA | NA | NA |
,Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 1.7 | 0.9 | 2.8 | 1.1 |
,Vitamin K Antagonist (VKA) | 2.9 | 4.4 | 3.7 | 1.8 |
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Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)
The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor. (NCT01852175)
Timeframe: 1 week
Intervention | PRI% (Least Squares Mean) |
---|
Prasugrel | 32.1 |
Ticagrelor | 32.6 |
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Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)
A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose. (NCT01852175)
Timeframe: 2 hours
Intervention | PRI% (Least Squares Mean) |
---|
Prasugrel | 13.4 |
Ticagrelor | 15.6 |
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Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)
A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose. (NCT01852175)
Timeframe: 24 hours
Intervention | PRI% (Least Squares Mean) |
---|
Prasugrel | 14.2 |
Ticagrelor | 26.4 |
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P2Y12 Reaction Units
The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence. (NCT01852214)
Timeframe: 1 week
Intervention | PRU (Least Squares Mean) |
---|
Prasugrel | 83 |
Ticagrelor | 52 |
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Platelet Reactivity Index
The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition. (NCT01852214)
Timeframe: 2 hours
Intervention | PRI (Least Squares Mean) |
---|
Prasugrel | 35 |
Ticagrelor | 37 |
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Platelet Reactivity Index
The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition. (NCT01852214)
Timeframe: 1 week
Intervention | PRI (Least Squares Mean) |
---|
Prasugrel | 36 |
Ticagrelor | 36 |
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P2Y12 Reaction Units
Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel) (NCT01852214)
Timeframe: 2 hours
Intervention | PRU (Least Squares Mean) |
---|
Prasugrel | 97 |
Ticagrelor | 75 |
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the Percentage Inhibition of the P2Y12 Receptor
(NCT01864005)
Timeframe: at 24 hours after first dose of study drug
Intervention | Percentage Inhibition (Mean) |
---|
Ticagrelor | 79.25 |
Clopidogrel | 28.76 |
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the Percentage Inhibition of the P2Y12 Receptor
(NCT01864005)
Timeframe: at 6 weeks after first dose of study drug
Intervention | Percentage Inhibition (Mean) |
---|
Ticagrelor | 83.78 |
Clopidogrel | 24.22 |
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the Percentage Inhibition of the P2Y12 Receptor
Note: the primary endpoint was changed per the statistical analysis plan prior database lock. (NCT01864005)
Timeframe: at 2 hours after first dose of study drug
Intervention | Percentage Inhibition (Mean) |
---|
Ticagrelor | 48.20 |
Clopidogrel | 9.78 |
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the Percentage Inhibition of the P2Y12 Receptor
(NCT01864005)
Timeframe: at 0.5 hour after first dose of study drug
Intervention | Percentage Inhibition (Mean) |
---|
Ticagrelor | 8.23 |
Clopidogrel | -3.91 |
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the Percentage Inhibition of the P2Y12 Receptor
(NCT01864005)
Timeframe: at 8 hours after first dose of study drug
Intervention | Percentage Inhibition (Mean) |
---|
Ticagrelor | 67.91 |
Clopidogrel | 25.38 |
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Bleeding Events
PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal (NCT01870921)
Timeframe: 12 months
Intervention | Participants (Number) |
---|
| Fatal/life threatening | Major | Major + minor | Major + minor + minimal |
---|
Ticargrelor | 17 | 27 | 93 | 426 |
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Serious Adverse Events Other Than Bleeding
SAEs except the blending events which have aleady been reported as SAEs. (NCT01870921)
Timeframe: 12 months
Intervention | Participants (Number) |
---|
Ticargrelor | 116 |
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Major CV Events
Combination of CV death, MI, and stroke (NCT01870921)
Timeframe: 12 months
Intervention | Participants (Number) |
---|
Ticargrelor | 85 |
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Platelet Reactivity by VerifyNow P2Y12
The primary end-point of the study was the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 1 hour after administration (NCT01898442)
Timeframe: 1 hour
Intervention | PRU (Least Squares Mean) |
---|
Ticagrelor 180mg | 188 |
Ticagrelor 270mg | 125 |
Ticagrelor 360mg | 228 |
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Pharmacokinetic Profiles of Ticagrelor (Tmax)
Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated. (NCT01898442)
Timeframe: 24 hours
Intervention | hours (Geometric Mean) |
---|
Ticagrelor 180mg | 3.9 |
Ticagrelor 270mg | 5.0 |
Ticagrelor 360mg | 7.4 |
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Pharmacokinetic Profiles of Ticagrelor (Cmax)
Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated. (NCT01898442)
Timeframe: 24 hours
Intervention | ng/mL (Geometric Mean) |
---|
Ticagrelor 180mg | 789 |
Ticagrelor 270mg | 1208 |
Ticagrelor 360mg | 1208 |
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Pharmacokinetic Profiles of Ticagrelor (AUC0-t)
Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated. (NCT01898442)
Timeframe: 24 hours
Intervention | ng*hr/mL (Geometric Mean) |
---|
Ticagrelor 180mg | 7893 |
Ticagrelor 270mg | 12379 |
Ticagrelor 360mg | 12381 |
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Platelet Reactivity by VerifyNow P2Y12 at Other Time Points
Secondary outcomes included the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 30 min and 2, 4, 8, 24 hours after ticagrelor loading dose administration (NCT01898442)
Timeframe: 30 min and 2, 4, 8, 24 hours
Intervention | PRU (Least Squares Mean) |
---|
| 30 min | 2 hours | 4 hours | 8 hours | 24 hours |
---|
Ticagrelor 180mg | 231 | 90 | 75 | 60 | 39 |
,Ticagrelor 270mg | 225 | 83 | 46 | 44 | 41 |
,Ticagrelor 360mg | 249 | 148 | 69 | 78 | 72 |
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Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points
Secondary outcomes included the comparison of the platelet reactivity index (PRI) determined by vasodilator-stimulated phosphoprotein (VASP) at 30 min and 1, 2, 4, 8, 24 hours after ticagrelor loading dose administration (NCT01898442)
Timeframe: 30 min and 1, 2, 4, 8, 24 hours
Intervention | PRI (Least Squares Mean) |
---|
| 30 min | 1 hour | 2 hours | 4 hours | 8 hours | 24 hours |
---|
Ticagrelor 180mg | 76 | 56 | 41 | 35 | 25 | 27 |
,Ticagrelor 270mg | 81 | 51 | 39 | 30 | 30 | 30 |
,Ticagrelor 360mg | 78 | 78 | 48 | 21 | 23 | 28 |
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Bleeding Complications
Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs. (NCT01919723)
Timeframe: up to 24 hours
Intervention | Number of subjects (Number) |
---|
Ticagrelor and Eptifibatide Bolus | 0 |
Ticagrelor & Eptifibatide Bolus+Infusion | 1 |
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Change in Percent Inhibition of Platelet Aggregation (%IPA)
Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide. (NCT01919723)
Timeframe: Baseline and 2 hours
Intervention | percentage of IPA (Mean) |
---|
Ticagrelor and Eptifibatide Bolus | 99.59 |
Ticagrelor & Eptifibatide Bolus+Infusion | 99.88 |
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Periprocedural Myocardial Infarction (PMI)
Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values >5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values >20% after PCI if the baseline value was elevated. (NCT01919723)
Timeframe: Up to 24 hours
Intervention | Number of subjects (Number) |
---|
Ticagrelor and Eptifibatide Bolus | 9 |
Ticagrelor & Eptifibatide Bolus+Infusion | 7 |
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High On-treatment Platelet Reactivity (HPR)
Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP. (NCT01919723)
Timeframe: Comparing baseline and follow-up (2 hours)
Intervention | percentage of participants (Number) |
---|
| Baseline | 2 h |
---|
Ticagrelor & Eptifibatide Bolus+Infusion | 79 | 0 |
,Ticagrelor and Eptifibatide Bolus | 89 | 0 |
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Platelet Reactivity Index(PRI) Measured by VASP-P
Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI). (NCT01962428)
Timeframe: 2 hours after the loading dose of ticagrelor
Intervention | percentage of 100 (Median) |
---|
Conventional Loading Dose of Ticagrelor | 16.7 |
High Loading Dose of Ticagrelor | 12.2 |
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TIMI Major Bleeding Event (Primary Safety Objective)
Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication (NCT01991795)
Timeframe: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 206 |
Ticagrelor Placebo | 100 |
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TIMI Major or Minor Bleeding Event
Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication (NCT01991795)
Timeframe: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 285 |
Ticagrelor Placebo | 129 |
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All-cause Death
Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent. (NCT01991795)
Timeframe: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 579 |
Ticagrelor Placebo | 592 |
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Composite of Cardiovascular (CV) Death, MI or Stroke
Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date. (NCT01991795)
Timeframe: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 736 |
Ticagrelor Placebo | 818 |
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CV Death
Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date. (NCT01991795)
Timeframe: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 364 |
Ticagrelor Placebo | 357 |
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Ischaemic Stroke
Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date. (NCT01991795)
Timeframe: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 152 |
Ticagrelor Placebo | 191 |
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MI
Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date (NCT01991795)
Timeframe: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 274 |
Ticagrelor Placebo | 328 |
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Permanent Discontinuation of Study Medication Due to Any Bleeding Event
Participants with permanent discontinuation of study medication due to any bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and the date of last dose of study medication (NCT01991795)
Timeframe: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 466 |
Ticagrelor Placebo | 125 |
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PLATO Major Bleeding Event
Participants with PLATO major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication (NCT01991795)
Timeframe: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
Intervention | Number of participants with event (Number) |
---|
Ticagrelor 60 mg | 310 |
Ticagrelor Placebo | 145 |
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Bleeding Events
Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events (NCT01992523)
Timeframe: 48 hours
Intervention | percentage of partecipants (Number) |
---|
Ticagrelor Mashed Pills | 2.4 |
Ticagrelor Integral Pills | 7 |
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Dyspnoea and/or Symptomatic Bradycardia
Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia (NCT01992523)
Timeframe: 6 months
Intervention | percentage of partecipants (Number) |
---|
Ticagrelor Mashed Pills | 12 |
Ticagrelor Integral Pills | 12 |
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Residual Platelet Reactivity
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD. (NCT01992523)
Timeframe: 1 hour
Intervention | PRU (P2Y12 reaction units) (Median) |
---|
Ticagrelor Mashed Pills | 168 |
Ticagrelor Integral Pills | 252 |
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High Residual Platelet Reactivity
The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD. (NCT01992523)
Timeframe: 1 hour
Intervention | percentage of partecipants (Number) |
---|
Ticagrelor Mashed Pills | 35 |
Ticagrelor Integral Pills | 63 |
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Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 423 |
ASA 100 mg | 475 |
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Net Clinical Outcome
Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 457 |
ASA 100 mg | 508 |
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Number of Participants With All-Cause Death
Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 68 |
ASA 100 mg | 58 |
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Number of Participants by Severity of Stroke and Overall Disability
"Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.~Modified Rankin Score:~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~Disability defined as mRS > 1.~Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables." (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 1107 |
ASA 100 mg | 1194 |
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EQ-5D at Visit 2 (Day 7+-2d)
"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: Visit 2 (Day 7+-2d)
Intervention | Index score (Mean) |
---|
Ticagrelor 90 mg | 0.80 |
ASA 100 mg | 0.79 |
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EQ-5D at Visit 1 (Enrolment)
"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: Visit 1 (Enrolment)
Intervention | Index score (Mean) |
---|
Ticagrelor 90 mg | 0.70 |
ASA 100 mg | 0.70 |
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EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: Premature treatment discontinuation visit(<15 days after last dose)
Intervention | Index score (Mean) |
---|
Ticagrelor 90 mg | 0.72 |
ASA 100 mg | 0.68 |
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EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1." (NCT01994720)
Timeframe: End of treatment visit (Day 90+-7d)
Intervention | Index score (Mean) |
---|
Ticagrelor 90 mg | 0.85 |
ASA 100 mg | 0.84 |
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Change in NIHSS
"Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):~0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke." (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
| <=-5 | -4 | -3 | -2 | -1 | 0 | 1 | 2 | 3 | 4 | 5 | >5 | Missing |
---|
ASA 100 mg | 127 | 438 | 810 | 1073 | 1131 | 683 | 79 | 31 | 16 | 11 | 6 | 14 | 450 |
,Ticagrelor 90 mg | 132 | 403 | 779 | 1088 | 1099 | 681 | 67 | 28 | 18 | 13 | 6 | 10 | 474 |
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Number of Participants With Stroke
Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 390 |
ASA 100 mg | 450 |
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Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). (NCT01994720)
Timeframe: Time from first dose and up to and including 7 days following the date of last dose of the study
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 82 |
ASA 100 mg | 37 |
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Number of Participants With PLATO Major Bleeding Event
"Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).~PLATO Major bleeding is defined as a bleed that is any one of:~Fatal~Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)~Intrapericardial bleed with cardiac tamponade~Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery~Significantly disabling (eg. intraocular with permanent vision loss)~Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)~Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding." (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 31 |
ASA 100 mg | 38 |
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Number of Participants With MI
Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 25 |
ASA 100 mg | 21 |
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Number of Participants With Ischaemic Stroke
Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 385 |
ASA 100 mg | 441 |
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Number of Participants With Fatal Stroke
Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 18 |
ASA 100 mg | 17 |
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Number of Participants With Disabling Stroke
Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 277 |
ASA 100 mg | 307 |
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Number of Participants With CV Death
Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 41 |
ASA 100 mg | 35 |
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Number of Participants With Composite of Stroke/MI/Death
Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). (NCT01994720)
Timeframe: From randomization up to 97 days
Intervention | Participants (Number) |
---|
Ticagrelor 90 mg | 442 |
ASA 100 mg | 497 |
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Ventilator Free Days
(NCT01998399)
Timeframe: 29 days
Intervention | days (Mean) |
---|
Ticagrelor | 24.16 |
Placebo | 22.3 |
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Time to Initiation of Unassisted Breathing
Only in patients on mechanical ventilation and assuming patient achieves 48 consecutive hours of unassisted breathing (NCT01998399)
Timeframe: 29 days
Intervention | hours (Mean) |
---|
Ticagrelor | 136.9 |
Placebo | 173.19 |
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Stroke, Myocardial Infarct, Mortality
number of participants that suffered stroke, myocardial infarct, mortality (NCT01998399)
Timeframe: 90 days
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 5 |
Placebo | 2 |
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Stroke
Did the patient develop a stroke during the 90 day study? (NCT01998399)
Timeframe: 90 days
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 1 |
Placebo | 0 |
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Hospital Length of Stay
In days (NCT01998399)
Timeframe: 29 days
Intervention | days (Mean) |
---|
Ticagrelor | 14.83 |
Placebo | 12.46 |
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Shock Free Days
Not requiring pressor support for hypotension (NCT01998399)
Timeframe: 15 days
Intervention | days (Mean) |
---|
Ticagrelor | 12.58 |
Placebo | 11.54 |
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Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support)
(NCT01998399)
Timeframe: 90 days
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Placebo | 0 |
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Need for Dialysis
(NCT01998399)
Timeframe: 28 days
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 1 |
Placebo | 0 |
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Myocardial Infarction
Did the patient have a myocardial infarction during the 90 day study? (NCT01998399)
Timeframe: 90 days
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 1 |
Placebo | 0 |
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In-hospital Mortality
Did the patient die during the hospitalization? (NCT01998399)
Timeframe: Throughout hospitalization (About 2 weeks)
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 2 |
Placebo | 2 |
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ICU Length of Stay
Includes ICU readmission if during same hospital stay (NCT01998399)
Timeframe: 29 days
Intervention | days (Mean) |
---|
Ticagrelor | 8.33 |
Placebo | 8.77 |
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All-cause Mortality
death during 90 day study period (NCT01998399)
Timeframe: 90 days
Intervention | participants (Number) |
---|
Ticagrelor | 4 |
Placebo | 2 |
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Hospital Free Days
Number of days the patient is not in the hospital (NCT01998399)
Timeframe: 29 days
Intervention | days (Mean) |
---|
Ticagrelor | 14.16 |
Placebo | 16.53 |
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Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay
The primary hypothesis of our study was that after 1 week of randomized treatment PRU levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel. (NCT02016170)
Timeframe: 7 days
Intervention | PRU (Least Squares Mean) |
---|
Ticagrelor | 45 |
Prasugrel | 63 |
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Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP).
The secondary hypothesis of our study was that after 1 week of randomized treatment PRI levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel. VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. (NCT02016170)
Timeframe: 7 days
Intervention | PRI (Least Squares Mean) |
---|
Ticagrelor | 25 |
Prasugrel | 36 |
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Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX
(NCT02022748)
Timeframe: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A | 1127.8 |
Treatment B | 1144.2 |
Treatment H | 1000.4 |
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Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor
(NCT02022748)
Timeframe: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Intervention | ng*h/mL (Geometric Mean) |
---|
Treatment A | 3015.1 |
Treatment B | 3256.1 |
Treatment H | 2188.8 |
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Pharmacokinetic Parameter Cmax of AR-C124910XX
(NCT02022748)
Timeframe: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Treatment A | 130.82 |
Treatment B | 152.25 |
Treatment H | 111.73 |
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Pharmacokinetic Parameter Cmax of Ticagrelor
(NCT02022748)
Timeframe: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Treatment A | 560.32 |
Treatment B | 598.35 |
Treatment H | 370.76 |
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Pharmacokinetic Parameter t1/2 of AR-C124910XX
(NCT02022748)
Timeframe: 3 days
Intervention | hour (Mean) |
---|
Treatment A | 7.574 |
Treatment B | 7.596 |
Treatment H | 8.644 |
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Pharmacokinetic Parameter t1/2 of Ticagrelor
(NCT02022748)
Timeframe: 3 days
Intervention | hour (Mean) |
---|
Treatment A | 8.303 |
Treatment B | 8.691 |
Treatment H | 8.412 |
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P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus (NCT02052635)
Timeframe: 0.5 hours post loading dose
Intervention | PRUs (Mean) |
---|
Ticagrelor | 289.2 |
Clopidogrel | 292.8 |
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P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus (NCT02052635)
Timeframe: 1 hour post loading dose
Intervention | PRUs (Mean) |
---|
Ticagrelor | 174.4 |
Clopidogrel | 249.8 |
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Saphenous Vein Graft Stenosis
The secondary objective of this clinical trial will be to evaluate whether, as compared to usual aspirin treatment, ticagrelor early after CABG prevents saphenous vein graft stenosis, defined as >50% narrowing of the graft, 1 year after surgery, as assessed by computed tomography (CT) coronary angiography. (NCT02053909)
Timeframe: 1 year after surgery
Intervention | percentage of veins stenosed (Number) |
---|
Aspirin | 4.1 |
Ticagrelor | 4.2 |
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Saphenous Vein Graft Occlusion
The primary objective of this clinical trial will be to evaluate whether, as compared to usual aspirin treatment, ticagrelor early after CABG prevents saphenous vein graft occlusion 1 year after surgery, as assessed by computed tomography (CT) coronary angiography. (NCT02053909)
Timeframe: 1 year after surgery
Intervention | percentage of veins occluded (Number) |
---|
Aspirin | 17.4 |
Ticagrelor | 13.2 |
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Safety---Clinical Chemistry Variables Over Time---Phosphate
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Phosphate" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | mmol/L (Mean) |
---|
Ticagrelor 45mg | 1.188 |
Ticagrelor 60mg | 1.154 |
Ticagrelor 90mg | 1.145 |
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Pharmacokinetics Parameters of Ticagrelor on Day 1(1)
The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax (NCT02064985)
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Intervention | ng/mL (Geometric Mean) |
---|
Ticagrelor 45mg | 464.0 |
Ticagrelor 60mg | 413.9 |
Ticagrelor 90mg | 822.1 |
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Safety---Hematology Laboratory Variables Over Time---Hemoglobin
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Hemoglobin" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | g/L (Mean) |
---|
Ticagrelor 45mg | 137.3 |
Ticagrelor 60mg | 135.4 |
Ticagrelor 90mg | 138.6 |
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Safety---Hematology Laboratory Variables Over Time---Leukocytes
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Leukocytes" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | 10^9/L (Mean) |
---|
Ticagrelor 45mg | 6.64 |
Ticagrelor 60mg | 6.30 |
Ticagrelor 90mg | 6.74 |
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Safety---Hematology Laboratory Variables Over Time---Platelets
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Platelets" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | 10^9/L (Mean) |
---|
Ticagrelor 45mg | 205.3 |
Ticagrelor 60mg | 186.7 |
Ticagrelor 90mg | 227.3 |
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Pharmacokinetics Parameters of Ticagrelor on Day 7(3)
Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h) (NCT02064985)
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Intervention | h*ng/mL (Geometric Mean) |
---|
Ticagrelor 45mg | 3882 |
Ticagrelor 60mg | 4351 |
Ticagrelor 90mg | 8206 |
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Safety---Vital Signs Over Time---Height
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Height)" (NCT02064985)
Timeframe: Baseline
Intervention | cm (Mean) |
---|
Ticagrelor 45mg | 166.9 |
Ticagrelor 60mg | 168.8 |
Ticagrelor 90mg | 166.5 |
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Safety---Vital Signs Over Time---Weight
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Weight)" (NCT02064985)
Timeframe: Baseline
Intervention | kg (Mean) |
---|
Ticagrelor 45mg | 78.7 |
Ticagrelor 60mg | 73.8 |
Ticagrelor 90mg | 73.4 |
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TIPA(Max)---Day 1
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA. (NCT02064985)
Timeframe: Day 1
Intervention | hour (Median) |
---|
Ticagrelor 45mg | 3.0 |
Ticagrelor 60mg | 4.5 |
Ticagrelor 90mg | 2.5 |
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TIPA(Max)---Day 7
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA. (NCT02064985)
Timeframe: Day 7
Intervention | hour (Median) |
---|
Ticagrelor 45mg | 1.5 |
Ticagrelor 60mg | 6.0 |
Ticagrelor 90mg | 1.3 |
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IPA on Day 1
"The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)." (NCT02064985)
Timeframe: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Intervention | % IPA (Mean) |
---|
| 0.5 hour after dose intake | 1 hour after dose intake | 2 hours after dose intake | 3 hours after dose intake | 6 hours after dose intake | 12 hours after dose intake | 24 hours after dose intake | 36 hours after dose intake | 48 hours after dose intake |
---|
Ticagrelor 45mg | 27.09 | 57.20 | 82.24 | 88.44 | 85.02 | 71.25 | 44.11 | 40.09 | 23.56 |
,Ticagrelor 60mg | 25.87 | 50.97 | 84.10 | 90.18 | 94.32 | 85.70 | 49.38 | 46.23 | 27.25 |
,Ticagrelor 90mg | 33.34 | 61.64 | 86.11 | 96.24 | 94.02 | 90.70 | 66.48 | 55.64 | 43.04 |
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IPA on Day 7
"The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)." (NCT02064985)
Timeframe: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
Intervention | % IPA (Mean) |
---|
| 0 hour after dose intake | 0.5 hour after dose intake | 1 hour after dose intake | 2 hours after dose intake | 3 hours after dose intake | 6 hours after dose intake | 12 hours after dose intake |
---|
Ticagrelor 45mg | 79.69 | 84.70 | 88.82 | 88.30 | 91.00 | 91.13 | 86.55 |
,Ticagrelor 60mg | 89.26 | 89.96 | 93.28 | 94.62 | 97.01 | 92.94 | 92.01 |
,Ticagrelor 90mg | 95.10 | 96.90 | 96.47 | 98.29 | 98.86 | 98.87 | 96.81 |
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Pharmacokinetics Parameters of Ticagrelor on Day 7(1)
Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax (NCT02064985)
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Intervention | ng/mL (Geometric Mean) |
---|
Ticagrelor 45mg | 616.0 |
Ticagrelor 60mg | 689.4 |
Ticagrelor 90mg | 1273 |
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Pharmacokinetics Parameters of Ticagrelor on Day 7(2)
The pharmacokinetics parameters of ticagrelor on Day 7---tmax (NCT02064985)
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Intervention | hour (Median) |
---|
Ticagrelor 45mg | 2.00 |
Ticagrelor 60mg | 2.00 |
Ticagrelor 90mg | 2.00 |
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Pharmacokinetics Parameters of Ticagrelor on Day 7(4)
Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h)) (NCT02064985)
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Intervention | ratio (Geometric Mean) |
---|
Ticagrelor 45mg | 1.837 |
Ticagrelor 60mg | 1.882 |
Ticagrelor 90mg | 2.060 |
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Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alanine Aminotransferase" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | ukat/L (Mean) |
---|
Ticagrelor 45mg | 0.524 |
Ticagrelor 60mg | 0.429 |
Ticagrelor 90mg | 0.465 |
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Safety---Clinical Chemistry Variables Over Time---Albumin
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Albumin" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | g/L (Mean) |
---|
Ticagrelor 45mg | 44.77 |
Ticagrelor 60mg | 44.68 |
Ticagrelor 90mg | 46.07 |
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Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alkaline Phosphatase" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | ukat/L (Mean) |
---|
Ticagrelor 45mg | 1.172 |
Ticagrelor 60mg | 1.027 |
Ticagrelor 90mg | 1.028 |
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Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Aspartate Aminotransferase" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | ukat/L (Mean) |
---|
Ticagrelor 45mg | 0.497 |
Ticagrelor 60mg | 0.410 |
Ticagrelor 90mg | 0.433 |
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Safety---Clinical Chemistry Variables Over Time---Bicarbonate
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Bicarbonate" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | mmol/L (Mean) |
---|
Ticagrelor 45mg | 28.92 |
Ticagrelor 60mg | 28.55 |
Ticagrelor 90mg | 28.15 |
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Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Blood Urea Nitrogen" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | mmol/L (Mean) |
---|
Ticagrelor 45mg | 5.875 |
Ticagrelor 60mg | 6.392 |
Ticagrelor 90mg | 6.108 |
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Safety---Clinical Chemistry Variables Over Time---Chloride
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Chloride" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | mmol/L (Mean) |
---|
Ticagrelor 45mg | 103.2 |
Ticagrelor 60mg | 103.9 |
Ticagrelor 90mg | 104.4 |
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Safety---Clinical Chemistry Variables Over Time---Creatinine
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Creatinine" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | umol/L (Mean) |
---|
Ticagrelor 45mg | 81.92 |
Ticagrelor 60mg | 87.50 |
Ticagrelor 90mg | 83.50 |
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Safety---Clinical Chemistry Variables Over Time---Glucose
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Glucose" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | mmol/L (Mean) |
---|
Ticagrelor 45mg | 7.48 |
Ticagrelor 60mg | 7.26 |
Ticagrelor 90mg | 5.78 |
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Safety---Clinical Chemistry Variables Over Time---Potassium
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Potassium" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | mmol/L (Mean) |
---|
Ticagrelor 45mg | 4.41 |
Ticagrelor 60mg | 4.47 |
Ticagrelor 90mg | 4.26 |
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Safety---Clinical Chemistry Variables Over Time---Protein
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Protein" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | g/L (Mean) |
---|
Ticagrelor 45mg | 70.2 |
Ticagrelor 60mg | 69.8 |
Ticagrelor 90mg | 70.2 |
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Safety---Clinical Chemistry Variables Over Time---Sodium
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Sodium" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | mmol/L (Mean) |
---|
Ticagrelor 45mg | 140.7 |
Ticagrelor 60mg | 140.8 |
Ticagrelor 90mg | 141.3 |
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AUEC(Final Extent) on Day 1
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA. (NCT02064985)
Timeframe: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Intervention | %*h (Mean) |
---|
Ticagrelor 45mg | 2474.4 |
Ticagrelor 60mg | 2819.4 |
Ticagrelor 90mg | 3301.0 |
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Safety---Hematology Laboratory Variables Over Time---Erythrocytes
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Erythrocytes" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | 10^12/L (Mean) |
---|
Ticagrelor 45mg | 4.417 |
Ticagrelor 60mg | 4.409 |
Ticagrelor 90mg | 4.487 |
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Safety---Hematology Laboratory Variables Over Time---hematocrit
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---hematocrit" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | ratio (Mean) |
---|
Ticagrelor 45mg | 0.4083 |
Ticagrelor 60mg | 0.4020 |
Ticagrelor 90mg | 0.4153 |
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Percent Change From Baseline in PRU on Day 1
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA. (NCT02064985)
Timeframe: Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Intervention | % change from baseline (Mean) |
---|
| 0.5 hour after dose intake | 1 hour after dose intake | 2 hours after dose intake | 3 hours after dose intake | 6 hours after dose intake | 12 hours after dose intake | 24 hours after dose intake | 36 hours after dose intake | 48hours after dose intake |
---|
Ticagrelor 45mg | -19.20 | -60.00 | -72.60 | -71.58 | -60.27 | -41.93 | -35.94 | -9.57 | -15.19 |
,Ticagrelor 60mg | -13.76 | -35.25 | -61.23 | -75.42 | -67.98 | -47.15 | -28.34 | -1.91 | -0.57 |
,Ticagrelor 90mg | -19.59 | -67.70 | -78.85 | -87.97 | -81.08 | -73.47 | -54.61 | -22.59 | -16.38 |
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Percent Change From Baseline in PRU on Day 7
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA. (NCT02064985)
Timeframe: Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
Intervention | % change from baseline (Mean) |
---|
| 0.5 hour after dose intake | 1 hour after dose intake | 2 hours after dose intake | 3 hours after dose intake | 6 hours after dose intake | 12 hours after dose intake |
---|
Ticagrelor 45mg | -77.90 | -79.70 | -82.23 | -79.98 | -76.71 | -63.63 |
,Ticagrelor 60mg | -80.07 | -78.40 | -85.00 | -86.96 | -75.07 | -69.03 |
,Ticagrelor 90mg | -89.33 | -94.10 | -88.81 | -92.13 | -91.48 | -88.60 |
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Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t). (NCT02064985)
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Intervention | h*ng/mL (Geometric Mean) |
---|
| AUC(0-inf) | AUC(0-t) | AUC(0-12h) |
---|
Ticagrelor 45mg | 3220 | 3102 | 2114 |
,Ticagrelor 60mg | 3633 | 3533 | 2313 |
,Ticagrelor 90mg | 6234 | 6017 | 3983 |
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Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2 (NCT02064985)
Timeframe: Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Intervention | hour (Median) |
---|
| tmax | t½ |
---|
Ticagrelor 45mg | 2.00 | 10.07 |
,Ticagrelor 60mg | 3.00 | 9.008 |
,Ticagrelor 90mg | 2.00 | 9.802 |
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Safety---All Allowed Concomitant Medications During Study Treatment
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Concomitant medications" (NCT02064985)
Timeframe: All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.
Intervention | Participants (Number) |
---|
| Number of patients with allowed concomitant med | HMG CoA reductase inhibitors | ATORVASTATIN | SIMVASTATIN | ROSUVASTATIN | Beta blocking agents, selective | METOPROLOL | BISOPROLOL | ACE inhibitors, plain | PERINDOPRIL | FOSINOPRIL | ENALAPRIL | BENAZEPRIL | IMIDAPRIL | Dihydropyridine derivatives | AMLODIPINE | NIFEDIPINE | Other cardiac preparations | TRIMETAZIDINE | TRIMETAZIDINE HYDROCHLORIDE | Biguanides | METFORMIN | METFORMIN HYDROCHLORIDE | Organic nitrates | ISOSORBIDE MONONITRATE | Angiotensin II antagonists, plain | IRBESARTAN | LOSARTAN | TELMISARTAN | Alpha glucosidase inhibitors | ACARBOSE | Insulins and analogues for injection, fast-acting | INSULIN | INSULIN HUMAN | Enzymes | KALLIDINOGENASE | Folic acid and derivatives | FOLIC ACID | Alpha and beta blocking agents | CARVEDILOL | Other therapeutic products | CHINESE TRADITIONAL MEDICINE NOS | HERBAL NOS | Preparations inhibiting uric acid production | ALLOPURINOL | Sulfonamides, urea derivatives | GLIMEPIRIDE | GLIQUIDONE | ANTIHYPERTENSIVES | Aldose reductase inhibitors | EPALRESTAT | Angiotensin II antagonists and diuretics | HYDROCHLOROTHIAZIDE+ LOSARTAN | Antidepressants in combination with psycholeptics | FLUPENTIXOL+MELITRACEN | Benzodiazepine derivatives | ESTAZOLAM | Benzothiazepine derivatives | DILTIAZEM | Comb/complexes aluminium, calcium, magnesium comps | HYDROTALCITE | Fibrates | FENOFIBRATE | Insulins and analogues for inj,intermediate-acting | HUMULIN 70/30 | Insulins/analogues for inj,int/long-act+fast-actin | INSULIN ASPART | Nicotinic acid and derivatives | ACIPIMOX | Other antifungals for topical use | TERBINAFINE HYDROCHLORIDE | Other drugs for peptic ulcer and GORD | GEFARNATE | Other vasodilators used in cardiac diseases | NICORANDIL | Thiazolidinediones | ROSIGLITAZONE |
---|
Ticagrelor 45mg | 12 | 11 | 5 | 3 | 3 | 9 | 6 | 3 | 5 | 2 | 1 | 0 | 1 | 1 | 4 | 3 | 1 | 4 | 4 | 0 | 3 | 2 | 1 | 1 | 1 | 3 | 2 | 1 | 0 | 3 | 3 | 1 | 1 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 2 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Ticagrelor 60mg | 12 | 12 | 8 | 4 | 0 | 10 | 6 | 5 | 2 | 0 | 1 | 1 | 0 | 0 | 3 | 3 | 0 | 2 | 2 | 0 | 2 | 2 | 0 | 2 | 2 | 1 | 1 | 0 | 0 | 1 | 1 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 |
,Ticagrelor 90mg | 12 | 12 | 5 | 3 | 4 | 6 | 5 | 1 | 6 | 3 | 2 | 1 | 0 | 0 | 2 | 2 | 0 | 2 | 1 | 1 | 2 | 2 | 0 | 3 | 3 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
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Safety---Physical Examination, Summary of Abnormalities
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Physical examination" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | Participants (Number) |
---|
| Number of patients with abnormality | Abdomen | Cardiovascular | General appearance | Head and neck | Lymph nodes | Musculoskeletal / Extremities | Neurological | Respiratory | Skin | Thyroid |
---|
Ticagrelor 45mg | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 |
,Ticagrelor 60mg | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
,Ticagrelor 90mg | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
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AUEC(Final Extent) on Day 7
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA. (NCT02064985)
Timeframe: IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Intervention | %*h (Mean) |
---|
Ticagrelor 45mg | 1069.9 |
Ticagrelor 60mg | 1120.1 |
Ticagrelor 90mg | 1176.9 |
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Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Total Bilirubin" (NCT02064985)
Timeframe: 2 to 5 days after last dose
Intervention | umol/L (Mean) |
---|
Ticagrelor 45mg | 13.98 |
Ticagrelor 60mg | 14.58 |
Ticagrelor 90mg | 14.81 |
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Safety---Vital Signs Over Time---Blood Pressure
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (seated blood pressure [BP])" (NCT02064985)
Timeframe: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Intervention | mmHg (Mean) |
---|
| Diastolic Blood Pressure- Baseline | Diastolic Blood Pressure- Day 1 | Diastolic Blood Pressure-Day 2 | Diastolic Blood Pressure-Day 3 | Diastolic Blood Pressure-Day 4 | Diastolic Blood Pressure-Day 5 | Diastolic Blood Pressure-Day 6 | Diastolic Blood Pressure-Day 7 | Diastolic Blood Pressure-2-5 days after last Dose | Systolic Blood Pressure (mmHg)-Baseline | Systolic Blood Pressure-Day 1 | Systolic Blood Pressure-Day 2 | Systolic Blood Pressure-Day 3 | Systolic Blood Pressure-Day 4 | Systolic Blood Pressure-Day 5 | Systolic Blood Pressure-Day 6 | Systolic Blood Pressure-Day 7 | Systolic Blood Pressure-2-5 days after last Dose |
---|
Ticagrelor 45mg | 84.6 | 85.3 | 82.3 | 79.2 | 80.7 | 80.8 | 79.8 | 80.8 | 80.3 | 134.6 | 132.2 | 130.3 | 128.3 | 131.3 | 129.4 | 126.8 | 128.9 | 126.0 |
,Ticagrelor 60mg | 77.1 | 78.2 | 74.8 | 75.2 | 78.2 | 75.2 | 77.4 | 75.6 | 74.7 | 129.2 | 135.7 | 131.4 | 130.1 | 132.8 | 131.3 | 133.5 | 129.4 | 132.3 |
,Ticagrelor 90mg | 74.8 | 74.6 | 74.2 | 74.3 | 73.3 | 74.7 | 73.9 | 74.0 | 71.3 | 132.1 | 127.4 | 123.1 | 123.8 | 126.1 | 125.1 | 119.1 | 122.1 | 124.7 |
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Safety---Vital Signs Over Time---Pulse Rate
"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Pulse Rate)" (NCT02064985)
Timeframe: Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Intervention | BEATS/MIN (Mean) |
---|
| Pulse Rate (BEATS/MIN)- Baseline | Pulse Rate (BEATS/MIN)- Day 1 | Pulse Rate (BEATS/MIN)- Day 2 | Pulse Rate (BEATS/MIN)- Day 3 | Pulse Rate (BEATS/MIN)- Day 4 | Pulse Rate (BEATS/MIN)- Day 5 | Pulse Rate (BEATS/MIN)- Day 6 | Pulse Rate (BEATS/MIN)- Day 7 | Pulse Rate(BEATS/MIN)- 2 to 5 days after last dose |
---|
Ticagrelor 45mg | 63.3 | 64.2 | 64.6 | 67.3 | 65.3 | 66.7 | 66.8 | 65.4 | 64.6 |
,Ticagrelor 60mg | 60.5 | 60.6 | 59.8 | 60.4 | 61.7 | 62.7 | 59.9 | 62.7 | 61.8 |
,Ticagrelor 90mg | 59.1 | 61.3 | 63.3 | 61.3 | 63.7 | 64.2 | 64.1 | 62.9 | 63.0 |
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Platelet Reactivity
The primary endpoint is P2Y12 reaction unit (PRU) measured by the Verify Now P2Y12 assay 24hours/hospital discharge post randomization to prasugrel vs ticagrelor. PRU is is an arbitrary unit of measure to assess ADP-induced platelet aggregation. (NCT02065479)
Timeframe: 24 hours post loading dose
Intervention | PRU (Mean) |
---|
Ticagrelor | 36 |
Prasugrel | 33 |
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Adverse Drug Reaction
Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention. (NCT02075125)
Timeframe: 30 days
Intervention | participants (Number) |
---|
Prasugrel | 0 |
Ticagrelor | 0 |
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Bleeding Event
Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria. (NCT02075125)
Timeframe: 30 days
Intervention | participants (Number) |
---|
Prasugrel | 0 |
Ticagrelor | 0 |
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Major Adverse Cardiac and Cerebrovascular Events
Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30. (NCT02075125)
Timeframe: 30 days
Intervention | participants (Number) |
---|
Prasugrel | 0 |
Ticagrelor | 0 |
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Pre-procedure P2Y12 Reaction Units (PRU)
Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU). (NCT02075125)
Timeframe: Baseline
Intervention | PRU units (Median) |
---|
Prasugrel | 259 |
Ticagrelor | 261 |
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Pre-procedure Platelet Reactivity Index (PRI)
Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI). (NCT02075125)
Timeframe: Baseline
Intervention | percentage (Median) |
---|
Prasugrel | 51.2 |
Ticagrelor | 47.5 |
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Number of Participants With High Platelet Reactivity
Platelet reactivity were measured by VerifyNow (volumetrics accuretic,San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%. (NCT02075125)
Timeframe: 48 hours after loading dose of study drug
Intervention | participants (Number) |
---|
| PRU>235 | VASP-PRI>50% |
---|
Prasugrel | 0 | 0 |
,Ticagrelor | 0 | 0 |
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Number of Participants With Low Platelet Reactivity
Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups. (NCT02075125)
Timeframe: 48 hours after loading dose of study drug
Intervention | participants (Number) |
---|
| PRU<85 | VASP-PRI<16% |
---|
Prasugrel | 18 | 16 |
,Ticagrelor | 19 | 16 |
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Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)
PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment (NCT02081443)
Timeframe: Baseline
Intervention | %PRI (Mean) |
---|
| Without cangrelor | With cangrelor |
---|
Ticagrelor 180mg | 30 | 18 |
,Ticagrelor 90mg | 30 | 17 |
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PRI Measured by VASP
PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment (NCT02081443)
Timeframe: 4 hours
Intervention | %PRI (Mean) |
---|
| Without cangrelor | With cangrelor |
---|
Ticagrelor 180mg | 22 | 14 |
,Ticagrelor 90mg | 22 | 17 |
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PRI Measured by VASP
PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment (NCT02081443)
Timeframe: 1 hour
Intervention | %PRI (Mean) |
---|
| Without cangrelor | With cangrelor |
---|
Ticagrelor 180mg | 20 | 12 |
,Ticagrelor 90mg | 29 | 16 |
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To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI.
Patients platelet inhibition was analyzed based on the P2Y12 reaction units (PRU) as high on treatment platelet reactivity (HPR), defined as P2Y12 reaction units (PRU) ≥208 and appropriate platelet inhibition on (API), defined as P2Y12 reaction units (PRU) <208 (NCT02091921)
Timeframe: Two weeks
Intervention | P2Y12 reaction units (PRU) (Mean) |
---|
| Clopidogrel Baseline | Clopidogrel 6+-1 hour after the baseline dose | Ticagrelor Baseline | Ticagrelor 6+-1 hour after baseline |
---|
Ticagrelor | 173 | 140 | 71 | 63 |
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Establish the Number of Participants in the High On-treatment Platelet Reactivity (HPR) on Clopidogrel Group Who Demonstrated Appropriate Platelet Inhibition (API) After Switching to Ticagrelor for Two Weeks.
This measure was obtained by the number of participants who demonstrated high on treatment platelet reactivity (PRU > / = 208) on Clopidogrel, and the number of participants who also resulted in the Appropriate Platelet Inhibition (PRU < 208) after switching to Ticagrelor for two weeks of uninterrupted therapy x 100% . (NCT02091921)
Timeframe: Two weeks
Intervention | Participants (Count of Participants) |
---|
HPR on Clopidogrel and API on Ticagrelor | 17 |
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Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy.
Correlation between the P2Y12 Reaction Units (PRU) and the Vasodilator-Stimulated Phosphoprotein Assay-Platelet Reactivity Index (VASP-PRI) used to test the inhibition of platelet aggregation after two weeks of uninterrupted therapy with Clopidogrel versus Ticagrelor in CLI participants (NCT02091921)
Timeframe: Two weeks
Intervention | Correlation Coefficient (Number) |
---|
| Clopidogrel | Ticagrelor | Overall Group |
---|
Correlation of PRU and VASP-PRI | 0.73 | 0.47 | 0.6 |
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Establish the Number of Participants With Appropriate Platelet Inhibition on Clopidogrel Who Demonstrated Appropriate Platelet Inhibition After Switching to Ticagrelor for Two Weeks.
The measure was obtained from the number of participants in the Appropriate Platelet Inhibition (PRU < 208) on Clopidogrel and who remained with Appropriate Platelet Inhibition after switching to Ticagrelor for two weeks of uninterrupted therapy x 100 (NCT02091921)
Timeframe: Two weeks
Intervention | Participants (Count of Participants) |
---|
API on Clopidogrel and API on Ticagrelor | 32 |
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Time to First Adjudicated Stroke
"Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.~Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction" (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 17 |
Dabigatran Etexilate 150mg | 9 |
Warfarin | 13 |
Warfarin (Excluding Elder Patients Outside USA) | 8 |
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Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported. (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 76 |
Dabigatran Etexilate 150mg | 51 |
Warfarin | 69 |
Warfarin (Excluding Elder Patients Outside USA) | 52 |
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Time to First Adjudicated ST
Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported. (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 15 |
Dabigatran Etexilate 150mg | 7 |
Warfarin | 8 |
Warfarin (Excluding Elder Patients Outside USA) | 7 |
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Time to First Adjudicated SE
"Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.~SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy." (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 3 |
Dabigatran Etexilate 150mg | 1 |
Warfarin | 3 |
Warfarin (Excluding Elder Patients Outside USA) | 3 |
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Time to First Adjudicated MI
Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 44 |
Dabigatran Etexilate 150mg | 26 |
Warfarin | 29 |
Warfarin (Excluding Elder Patients Outside USA) | 22 |
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Time to First Adjudicated ISTH MBE or CRNMBE
"Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.~Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.~Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.~Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'." (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 151 |
Dabigatran Etexilate 150mg | 154 |
Warfarin | 264 |
Warfarin (Excluding Elder Patients Outside USA) | 196 |
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Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported. (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 149 |
Dabigatran Etexilate 150mg | 90 |
Warfarin | 131 |
Warfarin (Excluding Elder Patients Outside USA) | 98 |
All Dabigatran Etexilate | 239 |
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Time to Composite Endpoint of Death or First Thrombotic Event
Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE). (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 108 |
Dabigatran Etexilate 150mg | 60 |
Warfarin | 83 |
Warfarin (Excluding Elder Patients Outside USA | 60 |
All Dabigatran Etexilate | 168 |
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Time to Composite Endpoint of Death + MI + Stroke
Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported. (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 107 |
Dabigatran Etexilate 150mg | 60 |
Warfarin | 80 |
Warfarin (Excluding Elder Patients Outside USA) | 57 |
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Time to Adjudicated Undetermined Cause of Death
"Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.~This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was patient died) or when there was insufficient supporting information or detail to assign the cause of death." (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 4 |
Dabigatran Etexilate 150mg | 5 |
Warfarin | 4 |
Warfarin (Excluding Elder Patients Outside USA) | 3 |
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Time to Adjudicated Non-CV
"Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.~Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV" (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 14 |
Dabigatran Etexilate 150mg | 4 |
Warfarin | 13 |
Warfarin (Excluding Elder Patients Outside USA) | 8 |
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Time to Adjudicated CV
"Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.~CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes." (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 37 |
Dabigatran Etexilate 150mg | 21 |
Warfarin | 31 |
Warfarin (Excluding Elder Patients Outside USA) | 24 |
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Time to Adjudicated All Cause Death
Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death. (NCT02164864)
Timeframe: up to 30 months
Intervention | Participants (Count of Participants) |
---|
Dabigatran Etexilate 110mg | 55 |
Dabigatran Etexilate 150mg | 30 |
Warfarin | 48 |
Warfarin (Excluding Elder Patients Outside USA) | 35 |
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P2Y12 Reaction Unit (PRU)
Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor. (NCT02201394)
Timeframe: Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose
Intervention | PRU (Mean) |
---|
| Baseline | Post-dose 4 hours 0% | 4 hours 25% | 4 hours 50% | 4 hours 75% | Post-dose 6 hours 0% | 6 hours 25% | 6 hours 50% | 6 hours 75% | Post-dose 24 hours 0% | 24 hours 25% | 24 hours 50% | 24 hours 75% | Post-dose 48 hours 0% | 48 hours 25% | 48 hours 50% | 48 hours 75% |
---|
Loading Dose | 284.1 | 39.1 | 69.6 | 100.3 | 98.6 | 25.9 | 55.3 | 67.8 | 71.2 | 127.6 | 157.3 | 165.9 | 162.5 | 250.6 | 249.5 | 226.2 | 204.2 |
,Maintenance Dose | 284.1 | 37.5 | 72.2 | 88.4 | 85.9 | 24.0 | 46.0 | 55.4 | 67.7 | 119.0 | 147.6 | 158.0 | 154.0 | 214.8 | 219.7 | 221.2 | 203.9 |
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Platelet Aggregation Using Multiplate Analyzer
Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU * min. (NCT02201394)
Timeframe: Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dose
Intervention | 10 AU * min (Mean) |
---|
| Baseline (pre-dose | Post-dose 4 hours 0% | 4 hours 25% | 4 hours 50% | 4 hours 75% | Post-dose 6 hours 0% | 6 hours 25% | 6 hours 50% | 6 hours 75% | Post dose 24 hours 0% | 24 hours 25% | 24 hours 50% | 24 hours 75% | Post-dose 48 hours 0% | 48 hours 25% | 48 hours 50% | 48 hours 75% |
---|
Loading Dose | 67.0 | 13.6 | 18.7 | 21.4 | 23.6 | 12.3 | 17.3 | 20.7 | 22.3 | 24.9 | 39.7 | 49.3 | 52.8 | 41.3 | 57.7 | 68.6 | 72.8 |
,Maintenance Dose | 67.0 | 15.7 | 20.9 | 22.1 | 24.2 | 13.4 | 16.5 | 18.9 | 20.4 | 25.6 | 35.5 | 43.3 | 47.5 | 39.1 | 56.8 | 63.8 | 70.3 |
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The Number of Major Adverse Cardiovascular Event (MACE)
MACE, composite of CV death, myocardial infarction or stroke (ischaemic or unknown etiology) (NCT02201771)
Timeframe: up to 12 months
Intervention | events (Number) |
---|
Aspirin | 9 |
Ticagrelor Plus Aspirin | 4 |
Ticagrelor | 3 |
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Number of the Major Bleeding Events
"According to modified TIMI criteria, the Major Bleeding Events is defined as the combination of CABG-related bleeding and non-CABG-related major bleeding(Intracranial bleeding, Clinically overt signs of hemorrhage with hemoglobin drop ≥5 g/dL and Fatal bleeding)." (NCT02201771)
Timeframe: up to 12 months
Intervention | events (Number) |
---|
Aspirin | 0 |
Ticagrelor Plus Aspirin | 3 |
Ticagrelor | 2 |
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The Rate of Post-operative Atrial Fibrillation After CABG.
Number of Participants with Post-operative Atrial Fibrillation after CABG (NCT02201771)
Timeframe: up to 7 days
Intervention | Participants (Count of Participants) |
---|
Aspirin | 23 |
Ticagrelor Plus Aspirin | 20 |
Ticagrelor | 13 |
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The Patency of Saphenous Vein Grafts
"assessed by MSCTA or CAG. FitzGibbon grade A (stenosis <50%) is defined as patency." (NCT02201771)
Timeframe: up to 7 days
Intervention | percentage of patent SV grafts (Number) |
---|
Aspirin | 91.1 |
Ticagrelor Plus Aspirin | 94.9 |
Ticagrelor | 94.3 |
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The Patency of Saphenous Vein Grafts
"assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis <50%) is defined as patency." (NCT02201771)
Timeframe: up to 12 months
Intervention | percentage of patent SV grafts (Number) |
---|
Aspirin | 76.5 |
Ticagrelor Plus Aspirin | 88.7 |
Ticagrelor | 82.8 |
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The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification
Number of Participants Free of Angina per CCS Classification (NCT02201771)
Timeframe: up to 12 months
Intervention | Participants (Count of Participants) |
---|
Aspirin | 154 |
Ticagrelor Plus Aspirin | 158 |
Ticagrelor | 155 |
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Assessment of AR-C124910XX Concentration - Part A
AR-C124910XX is the active metabolite of Ticagrelor (NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| Pre-dose | 1 hour post-dose | 2 hours post-dose |
---|
Ticagrelor 0.563 mg/kg Bid | 17.380 | 24.945 | 37.013 |
,Ticagrelor 0.75 mg/kg Bid | 20.359 | 43.986 | 44.690 |
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P2Y12 Reaction Units (PRU) - Part A
(NCT02214121)
Timeframe: PRU measurements are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14). Up to 8 hours post-dose (6 hours following protocol amendment) Visit 2 and 3, and up to 2 hours Visit 4.
Intervention | P2Y12 reaction units (Mean) |
---|
| Pre-dose | 2 hours post-dose |
---|
Ticagrelor 0.125 mg/kg Bid | 320 | 271.2 |
,Ticagrelor 0.563 mg/kg Bid | 205.4 | 102.0 |
,Ticagrelor 0.75 mg/kg Bid | 214.7 | 152.0 |
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P2Y12 Reaction Units (PRU) - Part A
(NCT02214121)
Timeframe: PRU measurements are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14). Up to 8 hours post-dose (6 hours following protocol amendment) Visit 2 and 3, and up to 2 hours Visit 4.
Intervention | P2Y12 reaction units (Mean) |
---|
| Pre-dose | 2 hours post-dose | 6 hours post-dose |
---|
Ticagrelor 0.75 mg/kg | 268.0 | 138.4 | 189.0 |
,Ticagrelor 1.125 mg/kg | 283.7 | 128.9 | 191.2 |
,Ticagrelor 2.25 mg/kg | 277.7 | 79.9 | 141.7 |
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P2Y12 Reaction Units (PRU) - Part A
(NCT02214121)
Timeframe: PRU measurements are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14). Up to 8 hours post-dose (6 hours following protocol amendment) Visit 2 and 3, and up to 2 hours Visit 4.
Intervention | P2Y12 reaction units (Mean) |
---|
| Pre-dose | 2 hours post-dose | 6 hours post-dose | 8 hours post-dose |
---|
Ticagrelor 0.125 mg/kg | 301.6 | 278.2 | 276.0 | 343.0 |
,Ticagrelor 0.375 mg/kg | 295.4 | 229.0 | 266.0 | 318.3 |
,Ticagrelor 0.563 mg/kg | 287.7 | 176.2 | 190.4 | 318.0 |
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P2Y12 Reaction Units (PRU) - Part B
(NCT02214121)
Timeframe: PRU measurements are taken after 4 weeks of double blind treatment at the end of Part B.
Intervention | P2Y12 reaction units (Mean) |
---|
| Pre-dose | 2 hours post-dose |
---|
Placebo | 313.3 | 217.3 |
,Ticagrelor 0.125 mg/kg Bid | 282.8 | 259.6 |
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Mean Intensity of Pain (Age >=4) - Part B
Pain measured using the Faces Pain Scale, range 0-10 (0, 2, 4, 6, 8, 10), where 0 is no pain (NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Mean score on scale (Mean) |
---|
| Overall - Part B | 1st week | 2nd week | 3rd week | 4th week |
---|
Part B - Placebo | 0.87 | 1.36 | 0.38 | 0.67 | 0.83 |
,Part B - Ticagrelor | 1.40 | 1.64 | 1.11 | 1.06 | 1.46 |
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Maximum Plasma Concentration (Cmax) - Part B
(NCT02214121)
Timeframe: PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.
Intervention | ng/mL (Geometric Mean) |
---|
Ticagrelor 0.125 mg/kg Bid | 16.394 |
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Area Under the Plasma Concentration Time Curve (AUC) - Part A
The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis. (NCT02214121)
Timeframe: PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).
Intervention | ng*h/mL (Geometric Mean) |
---|
Ticagrelor 0.125 mg/kg | 161.9 |
Ticagrelor 0.75 mg/kg | 1151.9 |
Ticagrelor 0.375 mg/kg | 437.5 |
Ticagrelor 0.563 mg/kg | 879.3 |
Ticagrelor 1.125 mg/kg | 1638.7 |
Ticagrelor 2.25 mg/kg | 2850.9 |
Ticagrelor 0.125 mg/kg Bid | 161.9 |
Ticagrelor 0.563 mg/kg Bid | 913.5 |
Ticagrelor 0.75 mg/kg Bid | 1022.4 |
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Area Under the Plasma Concentration Time Curve (AUC) - Part B
The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis. (NCT02214121)
Timeframe: PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.
Intervention | ng*h/mL (Geometric Mean) |
---|
Ticagrelor 0.125 mg/kg Bid | 160.6 |
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Haemorrhagic Events - Part A
(NCT02214121)
Timeframe: From randomisation to Part A (week 0) through Visit 4 (week 2)
Intervention | Number of events (Number) |
---|
Part A - Ticagrelor | 0 |
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Haemorrhagic Events - Part B
(NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Number of events (Number) |
---|
Part B - Ticagrelor | 0 |
Part B - Placebo | 0 |
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Maximum Plasma Concentration (Cmax) - Part A
(NCT02214121)
Timeframe: PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).
Intervention | ng/mL (Geometric Mean) |
---|
Ticagrelor 0.125 mg/kg | 15.240 |
Ticagrelor 0.75 mg/kg | 162.961 |
Ticagrelor 0.375 mg/kg | 52.069 |
Ticagrelor 0.563 mg/kg | 96.031 |
Ticagrelor 1.125 mg/kg | 269.174 |
Ticagrelor 2.25 mg/kg | 566.550 |
Ticagrelor 0.125 mg/kg Bid | 13.973 |
Ticagrelor 0.563 mg/kg Bid | 111.367 |
Ticagrelor 0.75 mg/kg Bid | 157.216 |
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Number of Vaso-occlusive Crises - Part B
(NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Number of events (Mean) |
---|
Part B - Ticagrelor | 1.0 |
Part B - Placebo | 0.6 |
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Number of Vaso-occlusive Crises Requiring Hospitalization or Emergency Department Visits - Part B
(NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Number of events (Mean) |
---|
Part B - Ticagrelor | 0.2 |
Part B - Placebo | 0.1 |
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Oral Clearance (CL/F) - Part A
The PK parameter presented were derived using a model based analysis and not from a non-compartmental (NCA) analysis. (NCT02214121)
Timeframe: PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).
Intervention | L/h (Geometric Mean) |
---|
Overall | 22.50 |
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Oral Clearance (CL/F) - Part B
The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis. (NCT02214121)
Timeframe: PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.
Intervention | L/h (Geometric Mean) |
---|
Ticagrelor 0.125 mg/kg Bid | 19.15 |
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Percentage of Days Hospitalized for Vaso-occlusice Crisis or Other Complications of Sickle Cell Disease - Part B
(NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Percentage of days (Mean) |
---|
Part B - Ticagrelor | 4.52 |
Part B - Placebo | 1.34 |
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Percentage of Days of Absence From School or Work (Age >=6) - Part B
(NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Percentage of days (Mean) |
---|
Part B - Ticagrelor | 4.87 |
Part B - Placebo | 5.95 |
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Percentage of Days of Analgesic Use (Age >= 4) - Part B
(NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Percentage of days (Mean) |
---|
Part B - Ticagrelor | 16.79 |
Part B - Placebo | 18.56 |
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Percentage of Days of Opioid Analgesic Use (Age >=4) - Part B
(NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Percentage of days (Mean) |
---|
Part B - Ticagrelor | 12.46 |
Part B - Placebo | 0.54 |
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Percentage of Days With Pain (Age >=4) - Part B
Pain measured using the Faces Pain Scale, range 0-10 (0, 2, 4, 6, 8, 10), where 0 is no pain (NCT02214121)
Timeframe: During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).
Intervention | Percentage of days (Mean) |
---|
Part B - Ticagrelor | 27.01 |
Part B - Placebo | 31.78 |
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Assessment of AR-C124910XX Concentration - Part A
AR-C124910XX is the active metabolite of Ticagrelor (NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| Pre-dose | 2 hours post-dose |
---|
Ticagrelor 0.125 mg/kg Bid | 1.250 | 4.026 |
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Assessment of AR-C124910XX Concentration - Part A
AR-C124910XX is the active metabolite of Ticagrelor (NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| 1 hour post-dose | 2 hours post-dose | 4 hours post-dose | 6 hours post-dose |
---|
Ticagrelor 0.75 mg/kg | 16.302 | 33.256 | 29.860 | 25.276 |
,Ticagrelor 1.125 mg/kg | 30.070 | 52.932 | 50.887 | 35.716 |
,Ticagrelor 2.25 mg/kg | 63.088 | 149.772 | 101.370 | 76.941 |
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Assessment of AR-C124910XX Concentration - Part A
AR-C124910XX is the active metabolite of Ticagrelor (NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| 1 hour post-dose | 2 hours post-dose | 4 hours post-dose | 6 hours post-dose | 8 hours post-dose |
---|
Ticagrelor 0.125 mg/kg | 1.782 | 2.681 | 2.071 | 1.646 | 1.715 |
,Ticagrelor 0.375 mg/kg | 4.577 | 11.757 | 7.630 | 9.762 | 6.176 |
,Ticagrelor 0.563 mg/kg | 3.708 | 15.918 | 17.015 | 16.703 | 9.232 |
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Assessment of AR-C124910XX Concentration - Part B
AR-C124910XX is the active metabolite of Ticagrelor (NCT02214121)
Timeframe: PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.
Intervention | ng/mL (Geometric Mean) |
---|
| Pre-dose | 1 hour post-dose | 2 hours post-dose | 4 hours post-dose |
---|
Ticagrelor 0.125 mg/kg Bid | 1.810 | 2.865 | 4.160 | 3.953 |
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Assessment of Ticagrelor Concentration - Part A
(NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| Pre-dose | 2 hours post-dose |
---|
Ticagrelor 0.125 mg/kg Bid | 2.170 | 13.973 |
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Assessment of Ticagrelor Concentration - Part A
(NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| Pre-dose | 1 hour post-dose | 2 hours post-dose |
---|
Ticagrelor 0.75 mg/kg Bid | 28.066 | 151.520 | 101.618 |
,Ticagrelor 0.563 mg/kg Bid | 31.937 | 80.414 | 102.166 |
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Assessment of Ticagrelor Concentration - Part A
(NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| 1 hour post-dose | 2 hours post-dose | 4 hours post-dose | 6 hours post-dose |
---|
Ticagrelor 0.75 mg/kg | 104.243 | 107.729 | 75.907 | 52.966 |
,Ticagrelor 1.125 mg/kg | 182.558 | 162.435 | 118.217 | 69.708 |
,Ticagrelor 2.25 mg/kg | 390.568 | 426.804 | 188.383 | 125.279 |
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Assessment of Ticagrelor Concentration - Part A
(NCT02214121)
Timeframe: In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)
Intervention | ng/mL (Geometric Mean) |
---|
| 1 hour post-dose | 2 hours post-dose | 4 hours post-dose | 6 hours post-dose | 8 hours post-dose |
---|
Ticagrelor 0.125 mg/kg | 12.713 | 11.465 | 6.647 | 3.663 | 3.880 |
,Ticagrelor 0.375 mg/kg | 34.069 | 37.782 | 20.122 | 19.435 | 15.699 |
,Ticagrelor 0.563 mg/kg | 33.294 | 74.626 | 51.005 | 45.502 | 15.691 |
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Assessment of Ticagrelor Concentration - Part B
(NCT02214121)
Timeframe: PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.
Intervention | ng/mL (Geometric Mean) |
---|
| Pre-dose | 1 hour post-dose | 2 hours post-dose | 4 hours post-dose |
---|
Ticagrelor 0.125 mg/kg Bid | 2.478 | 9.677 | 14.144 | 9.605 |
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Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h)
Exposure to ticagrelor during the first 6 hours after ticagrelor loading dose (NCT02217878)
Timeframe: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Intervention | ng*h/mL (Median) |
---|
Morphine | 2491 |
Placebo | 5587 |
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Maximum Concentration of AR-C124910XX
Maximum concentration (Cmax) of AR-C124910XX (NCT02217878)
Timeframe: 12 hours
Intervention | ng/mL (Median) |
---|
Morphine | 1085 |
Placebo | 1043 |
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Maximum Concentration of Ticagrelor
Maximum concentration (Cmax) of ticagrelor (NCT02217878)
Timeframe: 12 hours
Intervention | ng/mL (Mean) |
---|
Morphine | 1156 |
Placebo | 1683 |
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P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: 1 hour post ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 206.5 |
Placebo | 117.0 |
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P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: 12 hours post ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 9.0 |
Placebo | 7.5 |
[back to top]
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: 2 hours post ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 137.0 |
Placebo | 44.0 |
[back to top]
Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)
Exposure to ticagrelor metabolite during the first 12 hours after ticagrelor loading dose (NCT02217878)
Timeframe: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Intervention | ng*h/mL (Mean) |
---|
Morphine | 1503 |
Placebo | 2388 |
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Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6)
Exposure to ticagrelor metabolite during the first 6 hours after ticagrelor loading dose (NCT02217878)
Timeframe: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
Intervention | ng*h/mL (Median) |
---|
Morphine | 472 |
Placebo | 1001 |
[back to top]
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: 3 hours post ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 113.0 |
Placebo | 15.0 |
[back to top]
Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)
Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose (NCT02217878)
Timeframe: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Intervention | ng*h/mL (Mean) |
---|
Morphine | 6307 |
Placebo | 9791 |
[back to top]
P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: 30 minutes post ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 268.5 |
Placebo | 210.5 |
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P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: 4 hours post ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 50.5 |
Placebo | 9.0 |
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P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: 6 hours post ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 44.5 |
Placebo | 8.0 |
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P2Y12 Reaction Units Assessed by VerifyNow
P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208) (NCT02217878)
Timeframe: prior to the initial ticagrelor dose
Intervention | P2Y12 Reaction Units (Median) |
---|
Morphine | 232.5 |
Placebo | 238.5 |
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Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With MEA (NCT02217878)
Timeframe: 2 hours
Intervention | Percentage of Patients With HPR (Number) |
---|
Morphine | 40 |
Placebo | 14 |
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Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VASP (NCT02217878)
Timeframe: 2 hours
Intervention | Percentage of Patients With HPR (Number) |
---|
Morphine | 57 |
Placebo | 29 |
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Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow
Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VerifyNow (NCT02217878)
Timeframe: 2 hours
Intervention | Percentage of Patients With HPR (Number) |
---|
Morphine | 36 |
Placebo | 19 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: 1 hour post ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 59 |
Placebo | 23 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: 12 hours post ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 19 |
Placebo | 11 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: 2 hours post ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 31 |
Placebo | 23 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: 3 hours post ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 27 |
Placebo | 17 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: 30 minutes post ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 86 |
Placebo | 48 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: 4 hours post ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 29 |
Placebo | 13 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: 6 hours post ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 19 |
Placebo | 11 |
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Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry
Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units) (NCT02217878)
Timeframe: prior to the initial ticagrelor dose
Intervention | Platelet Arbitrary Aggregation Units (Median) |
---|
Morphine | 85 |
Placebo | 77 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: 1 hour post ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 70.2 |
Placebo | 42.0 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: 12 hours post ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 27.5 |
Placebo | 15.6 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: 2 hours post ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 52.1 |
Placebo | 26.2 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: 3 hours post ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 37.8 |
Placebo | 26.0 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: 30 minutes post ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 83.2 |
Placebo | 73.9 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: 4 hours post ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 36.9 |
Placebo | 23.2 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: 6 hours post ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 27.9 |
Placebo | 19.7 |
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Platelet Reactivity Index Assessed by VASP Assay
Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%) (NCT02217878)
Timeframe: prior to the initial ticagrelor dose
Intervention | Platelet Reactivity Index (%) (Median) |
---|
Morphine | 88.5 |
Placebo | 88.3 |
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Time to Maximum Concentration for AR-C124910XX
Time to maximum concentration (Tmax) for AR-C124910XX (NCT02217878)
Timeframe: 12 hours
Intervention | hours (Median) |
---|
Morphine | 4 |
Placebo | 4 |
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Time to Maximum Concentration for Ticagrelor
Time to maximum concentration (Tmax) for ticagrelor (NCT02217878)
Timeframe: 12 hours
Intervention | hours (Median) |
---|
Morphine | 4 |
Placebo | 2 |
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Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With MEA (NCT02217878)
Timeframe: 12 hours
Intervention | hours (Median) |
---|
Morphine | 2.0 |
Placebo | 1.0 |
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Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VASP (NCT02217878)
Timeframe: 12 hours
Intervention | hours (Median) |
---|
Morphine | 2.0 |
Placebo | 1 |
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Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow
Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VerifyNow (NCT02217878)
Timeframe: 12 hours
Intervention | hours (Median) |
---|
Morphine | 1.0 |
Placebo | 0.5 |
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Multiplate ADP Test
"Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets.~High on-treatment platelet reactivity was defined as >46 U." (NCT02224274)
Timeframe: 12 hours after P2Y12 inhibitor loading
Intervention | U (Mean) |
---|
Clopidogrel | 28 |
Ticagrelor | 15 |
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VerifyNow P2Y12Test - % Inhibition
% inhibition reflects P2Y12 inhibitor effect regarding basal platelet reactivity (defined as: (1- (platelet reactivity/basal platelet reactivity)) x 100). Higher values mean better P2Y12 inhibition response. High on-treatment platelet reactivity was defined as <11% inhibition. (NCT02224274)
Timeframe: 12 hours after P2Y12 inhibitor loading
Intervention | % inhibition (Mean) |
---|
Clopidogrel | 4 |
Ticagrelor | 55 |
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VerifyNow P2Y12Test - Platelet Reactivity
Platelet reactivity reflects P2Y12 inhibitor effect. Higher values mean normal platelet reactivity due to low P2Y12 inhibition response, while lower values mean decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU. (NCT02224274)
Timeframe: 12 h after P2Y12 inhibitor loading
Intervention | PRU (Mean) |
---|
Clopidogrel | 238 |
Ticagrelor | 101 |
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Absolute Change in TcPO2 From Baseline to Month 6
The primary endpoint is the absolute change in TcPO2 from baseline to month 6 compared between treatment groups. (NCT02230527)
Timeframe: 6 months
Intervention | mmHG (Mean) |
---|
Clopidogrel | 14.9 |
Ticagrelor | 4.2 |
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Number of Participants With BARC Type 2, 3, or 5
Number of participants with first occurrence of clinically relevant bleeding episode, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding. BARC bleeding types range from 0 (no bleeding) to 5 (fatal bleeding). (NCT02270242)
Timeframe: 12 months after randomization
Intervention | Participants (Count of Participants) |
---|
Placebo + Ticagrelor | 141 |
Aspirin + Ticagrelor | 250 |
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Number of Participants With Ischemic Episode
Number of participants with first occurrence of confirmed all-cause death, non-fatal myocardial infarction or stroke. (NCT02270242)
Timeframe: 12 months after randomization
Intervention | Participants (Count of Participants) |
---|
Placebo + Ticagrelor | 135 |
Aspirin + Ticagrelor | 137 |
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Platelet Reactivity Unit
PRU assessed by VerifyNow at 48 hours after switching of clopidogrel 600 mg LD administered 24 hours after the last ticagrelor MD vs. clopidogrel 75 mg MD given 24 hours after the last ticagrelor MD (NCT02287909)
Timeframe: 48 hours after switch
Intervention | PRU (Least Squares Mean) |
---|
A) Clopidogrel 600 mg LD 24 Hours After Last MD of Ticagrelor | 177 |
B) Clopidogrel 600 mg LD 12 Hours After Last MD of Ticagrelor | 164 |
C) Clopidogrel 75mg MD 24 Hours After Last MD of Ticagrelor | 174 |
D) Continue Ticagrelor MD 90mg Twice Daily | 26 |
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Major Adverse Cardiovascular Events
Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported. (NCT02291419)
Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Aspirin | 0 |
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Non-fatal Myocardial Infarction or Coronary Revascularization
Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported. (NCT02291419)
Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Aspirin | 0 |
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Non-fatal Stroke
Time to first occurence of Non-fatal stroke. The number of participants with events was reported. (NCT02291419)
Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Aspirin | 0 |
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The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions
(NCT02291419)
Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Aspirin | 0 |
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All-cause Death
Time to first occurence of All-cause death. The number of participants with events was reported. (NCT02291419)
Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Aspirin | 0 |
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Cardiovascular Death
Time to first occurence of Cardiovascular death. The number of patients with events was reported. (NCT02291419)
Timeframe: Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Aspirin | 0 |
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Mean Change in Microvascular Blood Flow Composite Score
Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index and toe pressures composite score at week 16 from baseline. Composite score obtained by adding all the measurements and averaged. The score was tested by the Laser Doppler Flowmetry (LDF). Minimum score is 0 which mean no blood flow detected and there is no maximum value of the score, and higher score mean better blood flow. (NCT02325466)
Timeframe: baseline and week 16
Intervention | score on a scale (Mean) |
---|
| Right side | Left side |
---|
Aspirin Placebo/Ticagrelor | -5.23 | -4.29 |
,Aspirin/Ticagrelor | 13.64 | 24.76 |
,Aspirin/Ticagrelor Placebo | -4.10 | -5.60 |
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Mean Change in High Shear Blood Viscosity
Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity at week 16 to baseline (NCT02325466)
Timeframe: baseline and week 16
Intervention | 300 s^-1 cPs (Mean) |
---|
Aspirin/Ticagrelor Placebo | 0.165 |
Aspirin/Ticagrelor | -0.228 |
Aspirin Placebo/Ticagrelor | -0.231 |
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Mean Change in Peripheral Arterial Blood Flow
"Measure of treatment effect using pulse volume recordings of the ankle, great toe and brachial artery to calculate the ankle brachial index (ABI) and toe brachial index (TBI) at week 16 compared to baseline.~ABI and TBI are taken in order to determine the existence and severity of peripheral arterial disease.~ABI - The normal range for the ankle-brachial index is between 0.90 and 1.30. ABI <0.90 is abnormal: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. The lower the index, the higher the chances of leg pain while exercising or limb-threatening low blood flow.~TBI ≥ 0.7 is normal, TBI < 0.7 is abnormal." (NCT02325466)
Timeframe: baseline and week 16
Intervention | index (Mean) |
---|
| ABI right side | ABI left side | TBI right side | TBI left side |
---|
Aspirin Placebo/Ticagrelor | 0.095 | 0.075 | 0.011 | 0.036 |
,Aspirin/Ticagrelor | 0.021 | 0.032 | 0.009 | -0.016 |
,Aspirin/Ticagrelor Placebo | 0.038 | 0.015 | 0.044 | 0.004 |
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Mean Change in Low Shear Blood Viscosity
Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline (NCT02325466)
Timeframe: baseline, week 16
Intervention | 5 s^-1 cPs (Mean) |
---|
Aspirin/Ticagrelor Placebo | 1.045 |
Aspirin/Ticagrelor | -1.793 |
Aspirin Placebo/Ticagrelor | -1.759 |
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Treatment Efficacy of Ticagrelor to Preserve Patency of Hemodialysis Vascular Access
Percentage of participants with stenosis free survival (NCT02335099)
Timeframe: 1 year
Intervention | percentage of participants (Number) |
---|
Treatment | 72.2 |
Placebo | 75.0 |
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Feasibility and Safety of Ticagrelor in Hemodialysis Patients
Number of Participants with prolonged bleeding (>30 minutes) after removal of needles (NCT02335099)
Timeframe: 6 months
Intervention | Participants (Count of Participants) |
---|
Treatment | 1 |
Placebo | 3 |
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Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)
(NCT02376283)
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutes
Intervention | P2Y12 reaction units (PRU) (Mean) |
---|
| STEMI at 20 mins | STEMI at balloon inflation | STEMI at 60 mins | STEMI at 240 mins | NSTEMI at 20 mins | NSTEMI at 60 mins | NSTEMI at 240 mins |
---|
Clopidogrel | 270.23 | 286.46 | 293.46 | 226.42 | 213.21 | 227.36 | 214.00 |
,Prasugrel | 247.73 | 253.73 | 262.87 | 128.64 | 125.80 | 76.93 | 31.87 |
,Ticagrelor | 256.73 | 257.93 | 225.20 | 176.27 | 172.80 | 114.20 | 23.00 |
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Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)
(NCT02376283)
Timeframe: Balloon Inflation as Baseline, 20, 60, 240 minutes
Intervention | %PRI (Mean) |
---|
| STEMI at 20 mins | STEMI at balloon inflation | STEMI at 60 mins | STEMI at 240 mins | NSTEMI at 20 mins | NSTEMI at 60 mins | NSTEMI at 240 mins |
---|
Clopidogrel | 76.29 | 74.86 | 71.57 | 63.14 | 75.17 | 76.75 | 61.83 |
,Prasugrel | 46.25 | 41.13 | 50.50 | 57.00 | 33.27 | 21.91 | 15.18 |
,Ticagrelor | 79.75 | 74.63 | 76.25 | 51.38 | 62.00 | 33.17 | 20.17 |
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Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period). (NCT02400333)
Timeframe: 0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Intervention | h·ng/mL (Geometric Mean) |
---|
| Ticagrelor | AR-C124910XX |
---|
Treatment A | 3068 | 1138 |
,Treatment B | 3228 | 1155 |
,Treatment C | 3226 | 1154 |
,Treatment D | 3423 | 1197 |
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Participants With Significant Findings in 12-Lead Electrocardiography (ECG).
A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded. (NCT02400333)
Timeframe: At screening and at follow-up.
Intervention | participants (Number) |
---|
Treatment A | 0 |
Treatment B | 0 |
Treatment C | 0 |
Treatment D | 0 |
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Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.
Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein). (NCT02400333)
Timeframe: At screening, at admission on Day -1 to each treatment period and at follow-up.
Intervention | participants (Number) |
---|
Treatment A | 0 |
Treatment B | 0 |
Treatment C | 0 |
Treatment D | 0 |
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Mean Change From Baseline for Vital Signs in Supine Pulse Rate.
Vital signs were collected after the participant has rested in the supine position for at least 5 minutes. (NCT02400333)
Timeframe: Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).
Intervention | bpm (Mean) |
---|
| Day 1, 2h Post-dose | Day 1, 4 Post-dose | Day 2, 24h Post-dose |
---|
Treatment A | 0 | 1 | 0 |
,Treatment B | -1 | -1 | 1 |
,Treatment C | -1 | -1 | 1 |
,Treatment D | 0 | 2 | 1 |
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Percentage of Participants With Adverse Events (AEs).
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. (NCT02400333)
Timeframe: SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.
Intervention | percentage of participants (Number) |
---|
| AEs | SAEs |
---|
Treatment A | 9.7 | 0 |
,Treatment B | 15.6 | 0 |
,Treatment C | 8.8 | 0 |
,Treatment D | 6.1 | 0 |
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Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).
The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP. (NCT02400333)
Timeframe: Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).
Intervention | mmHg (Mean) |
---|
| SBP - Day 1, 2h Post-dose | SBP - Day 1, 4 Post-dose | SBP - Day 2, 24h Post-dose | DBP - Day 1, 2h Post-dose | DBP - Day 1, 4 Post-dose | DBP - Day 2, 24h Post-dose |
---|
Treatment A | -2 | 0 | -2 | -1 | 0 | 0 |
,Treatment B | -2 | 1 | -1 | -1 | -1 | -3 |
,Treatment C | -1 | -1 | -3 | -4 | -3 | -3 |
,Treatment D | 3 | 2 | 1 | 0 | 0 | -1 |
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Platelet Reactivity Measured by VerifyNow P2Y12
Platelet reactivity measured by VerifyNow P2Y12 2 hours after ticagrelor loading dose and reported as P2Y12 reaction units (PRU) (NCT02403830)
Timeframe: 2 hours
Intervention | PRU (Least Squares Mean) |
---|
Methylnaltrexone | 130 |
Placebo | 97 |
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AUC of Ticagrelor Plasma Levels
The area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC) was calculated based on ticagrelor plasma levels (NCT02403830)
Timeframe: 6 hours
Intervention | ng*hr/mL (Geometric Mean) |
---|
Methylnaltrexone | 2952 |
Placebo | 2276 |
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Platelet Reactivity Measured by VASP
Platelet reactivity measured by VASP 2 hours after ticagrelor loading dose and reported as platelet reactivity index (PRI) (NCT02403830)
Timeframe: 2 hours
Intervention | PRI (Least Squares Mean) |
---|
Methylnaltrexone | 47 |
Placebo | 40 |
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Number of Participants With Adverse Events (AEs)
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. (NCT02436577)
Timeframe: From the date of randomization (Day 1 of the first treatment period) until the final follow-up visit (5 to 10 days after last administration of IMP).
Intervention | Participants (Number) |
---|
| Participants with any AE | Participants with SAEs |
---|
Treatment A | 3 | 0 |
,Treatment B | 4 | 0 |
,Treatment C | 3 | 0 |
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Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.
Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein). (NCT02436577)
Timeframe: At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).
Intervention | participants (Number) |
---|
Treatment A | 0 |
Treatment B | 0 |
Treatment C | 0 |
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Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP)
The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP. (NCT02436577)
Timeframe: Day 1 (pre dose, 2 hours, and 4 hours post dose) and Day 2 (24 hours post dose).
Intervention | mmHg (Mean) |
---|
| SBP: Day 1, 2 hours post dose | SBP: Day 1, 4 hours post dose | SBP: Day 2, 24 hours post dose | DBP: Day 1, 2 hours post dose | DBP: Day 1, 4 hours post dose | DBP: Day 2, 24 hours post dose |
---|
Treatment A | 0 | 3 | 2 | -3 | -1 | 1 |
,Treatment B | 0 | 0 | 1 | -2 | 0 | 1 |
,Treatment C | 0 | 3 | 1 | -2 | -1 | -2 |
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Mean Change From Baseline for Vital Signs in Supine Pulse Rate.
Vital signs i.e. Pulse (beats per minute [bpm]) were collected after the participant has rested in the supine position for at least 5 minutes. (NCT02436577)
Timeframe: At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart) and during treatment periods at pre-dose and post-dose at 2, 4 and 24 hours.
Intervention | bpm (Mean) |
---|
| Day 1, 2 hours post dose | Day 1, 4 hours post dose | Day 2, 24 hours post dose |
---|
Treatment A | 1 | 2 | 1 |
,Treatment B | 3 | 4 | 2 |
,Treatment C | 1 | 4 | 1 |
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Participants With Significant Findings in 12-Lead Electrocardiography (ECG).
A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded. (NCT02436577)
Timeframe: At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).
Intervention | participants (Number) |
---|
Treatment A | 0 |
Treatment B | 0 |
Treatment C | 0 |
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Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events)
To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD (NCT02482298)
Timeframe: Baseline through Week 12
Intervention | Number of events (Number) |
---|
| Total number of bleeding events | Maximum severity of bleeding event: Minor | Max sever. of bleed event: Clin-relevant nonmajor | Maximum severity of bleeding event: Major |
---|
PLACEBO 10MG BID + PLACEBO 45MG BID | 2 | 0 | 2 | 0 |
,TICAGRELOR 10MG BID + PLACEBO 45MG BID | 2 | 1 | 1 | 0 |
,TICAGRELOR 45MG BID + PLACEBO 10MG BID | 2 | 0 | 2 | 0 |
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Change in Proportion of Days With Analgesic Use Measured by an eDiary
To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease. (NCT02482298)
Timeframe: Baseline through Week 12
Intervention | Proportion of days with analgesic use (Least Squares Mean) |
---|
PLACEBO 10MG BID + PLACEBO 45MG BID | -0.1991 |
TICAGRELOR 10MG BID + PLACEBO 45MG BID | -0.0799 |
TICAGRELOR 45MG BID + PLACEBO 10MG BID | -0.1016 |
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Average of the Daily Worst Pain Values Reported Via eDiary
To determine the efficacy of 2 different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. Intensity of pain was recorded on an 11-point scale where 0 represented no pain and 10 represented the worst pain imaginable. (NCT02482298)
Timeframe: Baseline through Week 12
Intervention | Average daily worst pain rating (Mean) |
---|
PLACEBO 10MG BID + PLACEBO 45MG BID | 1.02 |
TICAGRELOR 10MG BID + PLACEBO 45MG BID | 1.15 |
TICAGRELOR 45MG BID + PLACEBO 10MG BID | 1.74 |
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Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary
To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease. (NCT02482298)
Timeframe: Baseline through Week 12
Intervention | Proportion of days with pain (Least Squares Mean) |
---|
PLACEBO 10MG BID + PLACEBO 45MG BID | -0.1802 |
TICAGRELOR 10MG BID + PLACEBO 45MG BID | -0.1352 |
TICAGRELOR 45MG BID + PLACEBO 10MG BID | -0.1001 |
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Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients)
To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD (NCT02482298)
Timeframe: Baseline through Week 12
Intervention | Number of patients (Number) |
---|
| Patients with any bleeding events | Pts w/ any bleeding event requiring intervention |
---|
PLACEBO 10MG BID + PLACEBO 45MG BID | 2 | 2 |
,TICAGRELOR 10MG BID + PLACEBO 45MG BID | 2 | 1 |
,TICAGRELOR 45MG BID + PLACEBO 10MG BID | 2 | 2 |
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Change in IL-6 as Measured by Blood Test.
(NCT02486367)
Timeframe: Day 0,1,7,&30
Intervention | pg/mL (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 4.761 | 43.127 | 7.603 | 5.0825 |
,Ticagrelor | 4.4 | 52.125 | 7.18502 | 4.511 |
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Change in D-Dimer Levels as Measured by Blood Test
(NCT02486367)
Timeframe: Day 0,1,7,&30
Intervention | ng/mL (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 1564.668 | 2851.912 | 2653.55 | 1869.85 |
,Ticagrelor | 1377.07 | 2961.475 | 2635.958 | 1554.43 |
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Change in Mono-2b3a as Measured by Blood Test
(NCT02486367)
Timeframe: Day 0,1,7,&30
Intervention | percentage of monocytes (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 2.27 | 1.45 | 0.615 | 0.765 |
,Ticagrelor | 1.45 | 0.93 | 1.23 | 0.86 |
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Change in Mono-CD62P as Measured by Blood Test
(NCT02486367)
Timeframe: Day 0,1,7,&30
Intervention | percentage of monocytes (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 1.675 | 0.75 | 0.69 | 0.695 |
,Ticagrelor | 1.525 | 0.715 | 0.73 | 0.765 |
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Change in IL-8 as Measured by Blood Test
(NCT02486367)
Timeframe: Day0,1,7,&30
Intervention | pg/mL (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 6.841063 | 8.58 | 4.98 | 4.81 |
,Ticagrelor | 4.837371 | 7.558923 | 4.584426 | 3.783523 |
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Platelet Reactivity
Platelet reactivity will be measured and reported as platelet reactivity units (PRU) using the VerifyNow system. (NCT02486367)
Timeframe: Day 0,1,7,&30
Intervention | Platelet Reactivity Units (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 275.5 | 234 | 208 | 183 |
,Ticagrelor | 251 | 128.5 | 80 | 134.5 |
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Inflammatory Monocyte Proportion
The percentage of inflammatory (CD14+CD16+) monocytes as a proportion of total monocytes will be measured using flow cytometry on whole blood. (NCT02486367)
Timeframe: Day 0,1,7&30
Intervention | percentage of inflammatory monocyte (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 21.55103 | 22.23356 | 17.98342 | 17.93496 |
,Ticagrelor | 21.50033 | 25.12275 | 21.626 | 21.06446 |
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Change in sCD14 as Measured by Blood Test.
(NCT02486367)
Timeframe: Day 0,1,7,&30
Intervention | pg/mL (Median) |
---|
| Day 0 | Day 1 | Day 7 | Day 30 |
---|
Standard Care/Clopidogrel | 1638.721 | 1713.16 | 1765.934 | 1525.929 |
,Ticagrelor | 1712.943 | 1896.489 | 1958.013 | 2077.568 |
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Total Number of Responders
"A participant will be considered to have achieved the primary efficacy endpoint (a Responder) if she/he has >50% reduction in the number of monthly headache days during the month of therapy compared with participant's own baseline. If there is < 50% reduction in the number of migraine days, she/he will be considered a Non-Responder." (NCT02518464)
Timeframe: 1 month from baseline
Intervention | Participants (Count of Participants) |
---|
Ticagrelor 90 mg Twice Per Day | 17 |
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Platelet Reactivity Measured by Vasodilator Stimulated Phosphoprotein (VASP) Platelet Reactivity Index (PRI %)
The primary end point of the study was platelet reactivity assessed by VASP-PRI following treatment with ticagrelor 90mg between DM-CKD and DM-non-CKD cohorts. PRI % is a measure of platelet reactivity, where higher PRI levels represent higher platelet reactivity and lower effect of antiplatelet medications. PRI greater than 50% represents inadequate response to antiplatelet medications. (NCT02539160)
Timeframe: 7 days
Intervention | PRI% (Mean) |
---|
CKD - Ticagrelor 90 | 25 |
CKD - Ticagrelor 60 | 32 |
Non-CKD - Ticagrelor 90 | 31 |
Non-CKD - Ticagrelor 60 | 38 |
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Platelet Reactivity Measured by VerifyNow P2Y12
Platelet reactivity assessed by VerifyNow P2Y12 following treatment with ticagrelor 90mg or 60 mg between DM-CKD and DM-non-CKD cohorts. Results are expressed in P2Y12 reaction units (PRU). PRU is a measure of platelet reactivity, where higher PRU levels represent higher platelet reactivity and lower effect of antiplatelet medications. PRU greater than 208 represents inadequate response to antiplatelet medications. (NCT02539160)
Timeframe: 7 days
Intervention | PRU (Mean) |
---|
CKD - Ticagrelor 90 | 39 |
CKD - Ticagrelor 60 | 59 |
Non-CKD - Ticagrelor 90 | 51 |
Non-CKD - Ticagrelor 60 | 74 |
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Maximal Platelet Aggregation
The primary end point of our study is the comparison of maximal platelet aggregation measured by light transmittance aggregometry using CAT (collagen-ADP-TRAP) between DAPT and DAPT plus vorapaxar after 30 days of treatment. (NCT02545933)
Timeframe: 30 days
Intervention | percent aggregation (Mean) |
---|
DAPT Plus Vorapaxar | 52 |
Prasugrel/Ticagrelor Plus Vorapaxar | 64 |
DAPT | 74 |
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Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Thrombolysis in Myocardial Infarction (TIMI) defined bleeding events included: Major bleeding (including fatal bleeding and non-fatal bleeding [fulfilling the TIMI major bleeding definition], major or minor bleeding, minor bleeding, minimal bleeding, and any bleeding (defined as composite of major, minor, and minimal bleeding) (NCT02866175)
Timeframe: Day 1 to 12 months postdose
Intervention | Participants (Count of Participants) |
---|
| Major bleeding | Fatal bleeding | Major or minor bleeding | Minor bleeding | Minimal bleeding |
---|
Edoxaban Regimen | 15 | 1 | 124 | 113 | 117 |
,Vitamin K Antagonist Regimen | 24 | 4 | 144 | 126 | 131 |
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Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen
All major, clinically relevant non-major and minor bleeding are reported for the secondary outcome. Participants may have experiences more than 1 bleeding event, all occurrences are reported. Participants with International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: major or clinically relevant non-major bleeding (MCRB), major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding. (NCT02866175)
Timeframe: Day 1 to 12 months postdose
Intervention | Participants (Count of Participants) |
---|
| Major bleeding | Clinically relevant non-major bleeding | Minor bleeding | Symptomatic intracranial hemorrhage | Fatal major bleeding | Fatal intracranial hemorrhage | Life-threatening bleeding | Spontaneous bleeding |
---|
Edoxaban Regimen | 45 | 97 | 116 | 4 | 1 | 0 | 5 | 184 |
,Vitamin K Antagonist Regimen | 48 | 114 | 125 | 9 | 7 | 4 | 8 | 210 |
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Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Participants' first major or clinically relevant non-major bleeding (MCRB) events were reported. International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: MCRB, major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding. (NCT02866175)
Timeframe: Day 1 to 12 months postdose
Intervention | Participants (Count of Participants) |
---|
| Composite MCRB | Major bleeding | Clinically relevant non-major bleeding |
---|
Edoxaban Regimen | 128 | 39 | 89 |
,Vitamin K Antagonist Regimen | 152 | 44 | 108 |
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Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
"Bleeding Academic Research Consortium (BARC) bleeding events included: Bleeding (defined by BARC type 3 or 5), bleeding (defined by BARC type 2, 3, or 5), and any bleeding (defined as the composite of BARC type 1, 2, 3, or 5), where increases in BARC type indicate worse outcome.~Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consultation; Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation; Type 3: Overt bleeding plus hemoglobin drop of 3 to ≤5 g/dL (3a), ≥5 g/dl (3b), and intracranial hemorrhage (3c) Type 5: Fatal bleeding" (NCT02866175)
Timeframe: Day 1 to 12 months postdose
Intervention | Participants (Count of Participants) |
---|
| Bleeding (BARC Type 3 or 5) | Bleeding (BARC Type 2, 3, or 5) | Bleeding (BARC Type 1, 2, 3, or 5) |
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Edoxaban Regimen | 36 | 124 | 207 |
,Vitamin K Antagonist Regimen | 42 | 144 | 242 |
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
Treatment-emergent adverse events (TEAEs) in >1.0% of participants were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug. (NCT02866175)
Timeframe: Day 1 to 30 days after the last dose
Intervention | Participants (Count of Participants) |
---|
| Any TEAE | Infections and Infestations | Nasopharyngitis | Pneumonia | Bronchitis | Urinary tract infection | Respiratory tract infection | Influenza | Cardiac Disorders | Cardiac failure | Atrial fibrillation | Bradycardia | Cardiac failure congestive | Ventricular extrasystoles | Tachycardia | General Disorders & Administration Site Condition | Non-cardiac chest pain | Oedema peripheral | Asthenia | Chest pain | Fatigue | Gastrointestinal Disorders | Diarrhoea | Constipation | Abdominal pain upper | Gastritis | Nausea | Dyspepsia | Respiratory,Thoracic, and Mediastinal Disorders | Dyspnoea | Cough | Dyspnoea exertional | Chronic obstructive pulmonary disease | Musculoskeletal and Connective Tissue Disorders | Back pain | Arthralgia | Pain in extremity | Myalgia | Osteoarthritis | Investigations | Blood creatinine increased | Alanine aminotransferase increased | Blood pressure increased | Creatinine renal clearance decreased | Aspartate aminotransferase increased | International normalised ratio increased | Nervous System Disorders | Dizziness | Headache | Syncope | Vascular Disorders | Hypertension | Hypotension | Hypertensive crisis | Renal and Urinary Disorders | Renal failure | Acute kidney injury | Renal impairment | Injury, Poisoning, and Procedural Complications | Fall | Skin and Subcutaneous Tissue Disorders | Pruritus | Rash | Metabolism and Nutrition Disorders | Gout | Blood and Lymphatic System Disorders | Anaemia | Psychiatric Disorder | Insomnia | Ear and Labyrinth Disorders | Vertigo |
---|
Edoxaban Regimen | 457 | 145 | 25 | 20 | 19 | 14 | 12 | 10 | 136 | 40 | 39 | 10 | 8 | 7 | 11 | 113 | 30 | 31 | 21 | 7 | 11 | 110 | 23 | 11 | 6 | 9 | 8 | 8 | 87 | 22 | 21 | 18 | 6 | 69 | 14 | 11 | 5 | 8 | 9 | 70 | 15 | 8 | 12 | 12 | 7 | 0 | 83 | 30 | 19 | 8 | 55 | 23 | 14 | 11 | 49 | 11 | 8 | 7 | 44 | 8 | 55 | 12 | 10 | 42 | 11 | 41 | 19 | 23 | 8 | 12 | 8 |
,Vitamin K Antagonist Regimen | 447 | 140 | 22 | 22 | 20 | 19 | 15 | 7 | 134 | 47 | 41 | 7 | 8 | 8 | 3 | 98 | 24 | 22 | 14 | 11 | 6 | 83 | 19 | 7 | 10 | 5 | 5 | 3 | 72 | 26 | 11 | 5 | 10 | 83 | 14 | 12 | 13 | 8 | 5 | 79 | 13 | 13 | 8 | 7 | 11 | 12 | 65 | 22 | 12 | 6 | 62 | 23 | 14 | 8 | 55 | 12 | 13 | 8 | 44 | 12 | 33 | 7 | 9 | 42 | 4 | 35 | 20 | 20 | 8 | 16 | 5 |
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Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen
The main efficacy endpoints were defined as the composite of cardiovascular death (ARC), stroke (protocol defined), systemic embolic event (SEE), myocardial infarction (MI), or definite stent thrombosis. (NCT02866175)
Timeframe: Day 1 to 12 months postdose
Intervention | Participants (Count of Participants) |
---|
| Composite MEE event | Cardiovascular death (ARC) | Stroke (Protocol definition) | Systemic Embolic Event | Myocardial infarction | Definite stent thrombosis |
---|
Edoxaban Regimen | 49 | 10 | 10 | 0 | 22 | 7 |
,Vitamin K Antagonist Regimen | 46 | 12 | 11 | 0 | 18 | 5 |
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Visual Analog Scale Disease Activity
"The VAS is a psychometric response scale that ranges from no pain (0) to worst pain (100); patients mark a line on a continuum to indicate how they are feeling. Provides global assessment of RA severity." (NCT02874092)
Timeframe: 30 Days
Intervention | Units on VAS scale (Mean) |
---|
| Baseline | 30 days |
---|
Rheumatoid Arthritis | 47 | 23 |
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Disease Activity Score for 28-joint Counts (DAS28)
"The DAS28 is a composite score derived from 4 of these measures. This '28' version is a simplification of the original DAS score, which requires 44 joints to be counted. Other versions of the DAS28 allow the CRP to be used instead of the ESR, or the omission of either. To calculate the DAS28 your rheumatologist or specialist nurse will:-~count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask you (the patient) to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad).~These results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.~The total scale range is from 2 to 10, with higher scores indicating more disease activity." (NCT02874092)
Timeframe: 30 Days
Intervention | score on a scale (Mean) |
---|
| Baseline | 30 days |
---|
Rheumatoid Arthritis | 5.7 | 4.3 |
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Change in Brachial Artery Diameter
Endothelial function is characterized by flow-mediated vasodilation of the brachial artery, which is measured by comparing the brachial artery diameter at rest the diameter after increased forearm blood flow (reactive hyperemia). Brachial artery reactivity testing (BART) is a noninvasive technique for evaluating endothelial function (NCT02874092)
Timeframe: Baseline, 30 Days
Intervention | mm (Mean) |
---|
| Baseline | 30 days |
---|
Rheumatoid Arthritis | 2.5 | 2.5 |
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Number of Participants With a Change in high-on Treatment Platelet Reactivity (HPR)
We assessed platelet aggregation at baseline and during PCI by light transmission aggregomerty. The primary efficacy measure was HPR defined as platelet aggregation >59% at 2 h measured by the Chronlog aggregometer after stimulation with ADP 20 µM. (NCT02925923)
Timeframe: 5 times (at baseline, and at 0.5, 2, 4, and 24 hours after loading dose)
Intervention | count of participants (Number) |
---|
| Baseline (n-50, n-48) | 0.5 h (n-50, n-48) | 2 h (n-50, n-48) | 4 h (n-50, n-48) | 24 h (n-50, n-48) |
---|
Eptifibatide Bolus+Clopidogrel | 33 | 0 | 0 | 0 | 5 |
,Ticagrelor | 37 | 24 | 6 | 0 | 2 |
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Change in Hemoglobin Levels (g/dL)
Hemoglobin levels (g/dL) will be measured at baseline and on the next day after PCI. (NCT02925923)
Timeframe: At baseline and at 24 hours post-PCI
Intervention | g/dL (Mean) |
---|
| Baseline (hemoglobin, g/dL) | Post-PCI (hemoglobin, g/dL) |
---|
Eptifibatide Bolus+Clopidogrel | 13.34 | 12.71 |
,Ticagrelor | 13.52 | 12.73 |
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A Change in Hematocrit Levels
Hematocrit levels (%) will be measured at baseline and on the next day after PCI. (NCT02925923)
Timeframe: At baseline and at 24 hours post-PCI
Intervention | hematocrit (%) (Mean) |
---|
| Baseline (hematocrit, %) | Post-PCI (hematocrit, %) |
---|
Eptifibatide Bolus+Clopidogrel | 40.02 | 37.5 |
,Ticagrelor | 40.11 | 37.68 |
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Number of Patients With Minor Bleeding Complications
We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. (NCT02925923)
Timeframe: At 24 hours post-PCI
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Eptifibatide Bolus+Clopidogrel | 0 |
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Number of Patients With Minor Bleeding Complications
We evaluated the number of patients with minor bleeding complications. Minor bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL. (NCT02925923)
Timeframe: At 1 year post-PCI
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Eptifibatide Bolus+Clopidogrel | 0 |
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Number of Patients With Major Bleeding Complications
We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. (NCT02925923)
Timeframe: At 24 hours post-PCI
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Eptifibatide Bolus+Clopidogrel | 0 |
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Number of Patients With Major Bleeding Complications
We evaluated the number of patients with major bleeding complications. Major bleeding, based on Bleeding Academic Research Consortium (BARC), was defined as type 3a, bleeding + hemoglobin drop of 3 to <5 g/dL; type 3b, bleeding + hemoglobin drop ≥5 g/dL; and type C, intracranial hemorrhage. (NCT02925923)
Timeframe: At 1 year post-PCI
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 0 |
Eptifibatide Bolus+Clopidogrel | 0 |
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Number of Participants With a Periprocedural Myocardial Infarction and Injury (PMI)
The rate of PMI will be compared in patients randomized to crushed ticagrelor vs. eptifibatide bolus +clopidogrel (NCT02925923)
Timeframe: At baseline and every 8 hours post- PCI
Intervention | Participants (Count of Participants) |
---|
Ticagrelor | 24 |
Eptifibatide Bolus+Clopidogrel | 14 |
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Heparin Dose, Unit/Kg
For the heparin dose range for the two groups would have a minimum dose of 4693 and a maximum dose of 11141 units per kilogram.The higher the number is indicative that a higher dose of heparin is needed based on kilogram weight. (NCT02925923)
Timeframe: 24 hours after the PCI
Intervention | units per kilogram (Mean) |
---|
Ticagrelor | 8854 |
Eptifibatide Bolus+Clopidogrel | 6021 |
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Activated Clotting Time (ACT), Seconds
The Level of the highest ACT during PCI will be compared between the groups (NCT02925923)
Timeframe: At the end of PCI
Intervention | s (Mean) |
---|
Ticagrelor | 332 |
Eptifibatide Bolus+Clopidogrel | 278 |
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Platelet Aggregation Levels
The rates of platelet aggregation with ADP and TRAP will be measured in patients randomized to crushed ticagrelor vs. eptifibatide bolus+clopidogrel (NCT02925923)
Timeframe: At baseline and at 0.5, 2, 4, and 24 hours after loading dose
Intervention | μmol/L (Mean) |
---|
| Baseline (ADP 20) | 0.5 h (ADP 20) | 2 h (ADP 20) | 4 h (ADP 20) | 24 h (ADP 20) | Baseline (ADP 5) | 0.5 h (ADP 5) | 2 h (ADP 5) | 4 h (ADP 5) | 24 h (ADP 5) | Baseline (TRAP 20) | 0.5 h (TRAP 20) | 2 h (TRAP 20) | 4 h (TRAP 20) | 24 h (TRAP 20) | Baseline (TRAP 10) | 0.5 h (TRAP 10) | 2 h (TRAP 10) |
---|
Eptifibatide Bolus+Clopidogrel | 62 | 1.3 | .34 | 3.5 | 38 | 54 | 1.18 | .3 | 1.6 | 27 | 67 | 3.9 | 6 | 14 | 51 | 54 | 1.18 | 1.57 |
,Ticagrelor | 65 | 53 | 35 | 23 | 25 | 56 | 44 | 24 | 15 | 18 | 68 | 60 | 51 | 48 | 54 | 56 | 48 | 37 |
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Number of Patients With Negative Clinical Outcomes
The rates of death, myocardial infarction, and revascularization at 1-year post-PCI. (NCT02925923)
Timeframe: At 1-year post-PCI
Intervention | Participants (Count of Participants) |
---|
| Death | Myocardial infarction | Revascularization |
---|
Eptifibatide Bolus+Clopidogrel | 0 | 0 | 0 |
,Ticagrelor | 2 | 0 | 1 |
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Concentration of Platelet Extracellular Vesicles/ml
Concentration of platelet extracellular vesicles/ml measured with flow cytometry (NCT02931045)
Timeframe: 6 months following the beginning of antiplatelet therapy
Intervention | Platelet Extracellular Vesicles/mL (Median) |
---|
Ticagrelor | 2690000 |
Clopidogrel | 4310000 |
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Composite of Subsequent Stroke or Death
Participants with subsequent stroke or death (NCT03354429)
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)
Intervention | Participants (Count of Participants) |
---|
TICAGRELOR | 303 |
PLACEBO | 362 |
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ICH or Fatal Bleeding Event
Participants with ICH or fatal bleeding event (NCT03354429)
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)
Intervention | Participants (Count of Participants) |
---|
TICAGRELOR | 22 |
PLACEBO | 6 |
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Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Moderate/Severe
Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Moderate/Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention. GUSTO Moderate bleeding is a bleeding requiring transfusion of whole blood or packed red blood cells without haemodynamic compromise (NCT03354429)
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)
Intervention | Participants (Count of Participants) |
---|
TICAGRELOR | 36 |
PLACEBO | 11 |
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Bleeding Event That Fulfils Serious Adverse Event Criteria and is Categorised as GUSTO Severe
Participants with bleeding event that fulfils serious adverse event criteria and is categorised as GUSTO Severe. GUSTO is a bleeding scale (GUSTO = Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries). GUSTO Severe bleeding is defined as any of the following: (1) fatal bleeding, (2) intracranial bleeding, or (3) bleeding that caused haemodynamic compromise requiring intervention (NCT03354429)
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)
Intervention | Participants (Count of Participants) |
---|
TICAGRELOR | 28 |
PLACEBO | 7 |
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Ischaemic Stroke
Number of participants with ischaemic stroke (NCT03354429)
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)
Intervention | Participants (Count of Participants) |
---|
TICAGRELOR | 276 |
PLACEBO | 345 |
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Number of Participants With Modified Rankin Scale (mRS) Score >1 at Visit 3
The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.0 - No symptoms,1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. (NCT03354429)
Timeframe: Visit 3 (day 30-34)
Intervention | Participants (Count of Participants) |
---|
TICAGRELOR | 1282 |
PLACEBO | 1284 |
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Premature Permanent Discontinuation of IP Due to Bleeding
Participants with premature permanent discontinuation of IP due to bleeding (NCT03354429)
Timeframe: From randomisation (day 1) to visit 3 (day 30-34)
Intervention | Participants (Count of Participants) |
---|
TICAGRELOR | 152 |
PLACEBO | 32 |
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ADP-induced Platelet-fibrin Clot Strength (MA)
The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA). A MA>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy. Moreover, ROC curve and quartile analysis suggested MA<31 mm as a predictive value for post-PCI bleeding events (J Am Coll Cardiol. 2013;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101.). (NCT03381742)
Timeframe: up to 5 days
Intervention | mm (Median) |
---|
Clopidogrel 75mg Qdpo. | 40.3 |
Ticagrelor 90mg Bidpo. | 28.4 |
Ticagrelor 45mg Bidpo. | 32.3 |
Ticagrelor 90mg Qdpo. | 34.05 |
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ADP-induced Inhibition of Platelet Aggregation
The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens. The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin. Then the samples were processed within two hours of blood draw according to standard operating procedure. The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition. (NCT03381742)
Timeframe: up to 5 days
Intervention | percentage of inhibition of platelet agg (Median) |
---|
Clopidogrel 75mg Qdpo. | 54.9 |
Ticagrelor 90mg Bidpo. | 80.6 |
Ticagrelor 45mg Bidpo. | 73.6 |
Ticagrelor 90mg Qdpo. | 66 |
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P2Y12 Reaction Units (PRU)
The primary endpoint of our study will be platelet reactivity, measured as PRU level using VerifyNow PRU, of ticagrelor versus clopidogrel MD at 30 days after PCI, immediately pre-dosing dosing (trough levels). PRU is a marker of platelet reactivity. Higher PRU values correspond to higher aggregation and lower response to antiplatelet therapy. (NCT03437044)
Timeframe: 30 days
Intervention | PRU (Mean) |
---|
Ticagrelor | 60 |
Clopidogrel | 146 |
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Platelet Reactivity Index (PRI)
Platelet reactivity measured as PRI% using whole blood vasodilator-stimulated phosphoprotein (VASP), of ticagrelor versus clopidogrel MD at 30 days after PCI, immediately pre-dosing dosing (trough levels). PRI% is a marker of platelet reactivity. Higher PRI values correspond to higher aggregation and lower response to antiplatelet therapy. (NCT03437044)
Timeframe: 30 days
Intervention | PRI % (Mean) |
---|
Ticagrelor | 25 |
Clopidogrel | 65 |
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P2Y12 Reaction Unit (PRU)
Platelet reactivity measured by VerifyNow and reported as PRU (NCT03489863)
Timeframe: at 24 hours post loading dose
Intervention | PRU (Mean) |
---|
Prasugrel | 5 |
Ticagrelor | 24 |
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Percentage of Days of Absence From School or Work Due to Sickle Cell Disease
"For participants attending school/work at randomization, absence from school/work due to SCD was recorded weekly by the participant in the eDevice with the help of the caregiver if needed. The percentage of days absent from school/work due to SCD in the defined treatment period was calculated as follows:~Percentage of absent days = (total number of days reported)/(total number of questionnaires answered ×7)." (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | percentage of days (Mean) |
---|
Ticagrelor 15/30/45 mg bd | 5.24 |
Placebo | 4.24 |
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Type of Analgesics Used by Participants During Vaso-Occlusive Crisis Events
Analgesics use (opioid and non-opioid) during VOC events. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | participants (Number) |
---|
| Opioids: Yes | Opioids: No | Non-opioids: Yes | Non-opioids: No |
---|
Placebo | 22 | 50 | 57 | 7 |
,Ticagrelor 15/30/45 mg bd | 46 | 57 | 69 | 14 |
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Number of Vaso-Occlusive Crisis Events Requiring Hospitalization or Emergency Department Visits
The number of VOC events requiring hospitalization or emergency department visits is defined as the count of VOC events experienced by a participant over the treatment period, for which the primary setting for VOC treatment was in-patient hospitalization or emergency department. Events with an onset date <=7 days of the previous event onset date are not counted as new events. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | VOC events requiring hospitalization (Number) |
---|
Ticagrelor 15/30/45 mg bd | 87 |
Placebo | 51 |
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Number of Painful Crisis Events
A painful crisis is an onset or worsening of pain that lasts at least 2 hours, for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, parenteral non-steroidal anti-inflammatory drugs, or other analgesics prescribed by a healthcare provider in a medical setting (such as a hospital, clinic or emergency room visit) or at home. Events with an onset date <=7 days of the previous event onset date are not counted as new events. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | painful crisis events (Number) |
---|
Ticagrelor 15/30/45 mg bd | 248 |
Placebo | 209 |
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Number of Days Hospitalized for Vaso-Occlusive Crisis Events
The number of days hospitalized for all individual VOC events experienced by a participant during the treatment period is defined as the sum of the duration of all individual hospitalizations (taking into account potential overlapping hospitalization days of VOC components) during VOC events experienced by a participant over the treatment period for which the primary setting for VOC treatment was in-patient hospitalization. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | days (Number) |
---|
Ticagrelor 15/30/45 mg bd | 526 |
Placebo | 256 |
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Number of Days Hospitalized for Acute Sickle Cell Disease Complications
The number of days hospitalized for acute SCD complications is defined as the sum of the duration of all individual hospitalizations (taking into account potential overlapping hospitalization days) due to acute SCD complications experienced by a participant over the treatment period, for which hospitalization was reported. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | days (Number) |
---|
Ticagrelor 15/30/45 mg bd | 0 |
Placebo | 6 |
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Number of Acute Sickle Cell Disease Complications
The number of acute SCD complications is defined as the count of all individual acute SCD complications experienced by a participant over the treatment period. Acute SCD complications are defined as any one or more of the following individual complications: Transient ischaemic attack/ischaemic stroke, hepatic sequestration, splenic sequestration, priapism, and dactylitis. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | acute SCD complications (Number) |
---|
Ticagrelor 15/30/45 mg bd | 6 |
Placebo | 3 |
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Number of Vaso-Occlusive Crisis Events
A VOC is the composite of a painful crisis and/or an acute chest syndrome (ACS) event. The number of VOC events is defined as the count of VOC events experienced by a participant throughout the treatment period. (NCT03615924)
Timeframe: From randomization (Day 0) up to end of study (EOS) visit or date of premature study discontinuation, up to approximately 20 months
Intervention | VOC events (Number) |
---|
Ticagrelor 15/30/45 mg bd | 249 |
Placebo | 202 |
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Average Intensity of Worst Pain Daily During Vaso-Occlusive Crisis Events in Participants ≥5 Years of Age
"The Faces Pain Scale-revised (FPS-R) was administered to assess pain daily during the VOC event by those participants aged ≥5 years as determined at randomization. The FPS-R consists of 6 faces and scoring ranges between 0 and 10 (with an increase in numeric value by 2), where 0 is no pain and 10 is very much pain. Lower score indicate better outcome. Worst pain ratings were collected once daily throughout the duration of the VOC event using an eDevice." (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | score on a scale (Mean) |
---|
Ticagrelor 15/30/45 mg bd | 4.5 |
Placebo | 4.1 |
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Average Intensity of Worst Pain Daily During Vaso-Occlusive Crisis Events in Participants <5 Years of Age
"The Face, Legs, Activity, Cry, Consolability (FLACC) scale is caregiver-reported and used to assess pain daily during the VOC event for those participants <5 years of age as determined at randomization. Each of the 5 behaviours observed are assigned a score of 0, 1 or 2. The total FLACC score ranges between 0 and 10, with 0 representing no pain and 10 representing very much pain. Lower score indicate better outcome. Worst pain ratings were collected once daily throughout the duration of the VOC event using an eDevice." (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | score on a scale (Mean) |
---|
Ticagrelor 15/30/45 mg bd | 3.4 |
Placebo | 2.9 |
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Duration of Painful Crises
The duration of painful crises is defined as the sum of the duration of painful crises experienced by a participant over the defined treatment period. If two or more events have overlapping durations, the overlapping days were counted only once. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | days (Number) |
---|
Ticagrelor 15/30/45 mg bd | 1476 |
Placebo | 1441 |
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Number of Acute Chest Syndrome Events
The ACS is an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Events with an onset date <=7 days of the previous event onset date are not counted as new events. (NCT03615924)
Timeframe: From randomization (Day 0) up to EOS visit or date of premature study discontinuation, up to approximately 20 months
Intervention | ACS events (Number) |
---|
Ticagrelor 15/30/45 mg bd | 6 |
Placebo | 6 |
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Swallowability of the Study Treatment Assessed by Study Medication Palatability Assessment in Participants ≤4 Years of Age
"An observer's assessment of the participant's behaviour using the SMPA was performed for all participants taking the study treatment who are 2 to 4 years of age. Willingness to swallow was assessed and categorized as follows:~Swallowed without a problem~Some resistance but did swallow~Spit out some/all of the medication~Vomited up the medication. The category swallowed without a problem was considered as positive outcome." (NCT03615924)
Timeframe: Baseline (randomization visit) and Month 6
Intervention | Participants (Count of Participants) |
---|
| Baseline: Whole tablet72493825 | Baseline: Whole tablet72493826 | Baseline: Dispersed tablet72493825 | Baseline: Dispersed tablet72493826 | Month 6: Whole tablet72493825 | Month 6: Whole tablet72493826 | Month 6: Dispersed tablet72493825 | Month 6: Dispersed tablet72493826 |
---|
| Some resistance but did swallow | Spit out some/all medication | Vomited up medication | Swallow without problem |
---|
Ticagrelor 15/30/45 mg bd | 5 |
Placebo | 8 |
Ticagrelor 15/30/45 mg bd | 0 |
Placebo | 2 |
Ticagrelor 15/30/45 mg bd | 4 |
Placebo | 9 |
Ticagrelor 15/30/45 mg bd | 1 |
Placebo | 1 |
Placebo | 0 |
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Palatability of the Study Treatment Assessed by Study Medication Palatability Assessment (SMPA) in Participants ≤4 Years of Age
"Response to palatability was assessed through the SMPA question Was any behaviour observed when the study medication was given to this participant that would be indicative of a negative response to the palatability of the study medication?. This was presented as a binary outcome (that is, where No is no negative response and Yes is negative response). No negative response was considered as a positive outcome." (NCT03615924)
Timeframe: Baseline (randomization visit) and Month 6
Intervention | Participants (Count of Participants) |
---|
| Baseline: Whole tablet72493825 | Baseline: Whole tablet72493826 | Baseline: Dispersed tablet72493826 | Baseline: Dispersed tablet72493825 | Month 6: Whole tablet72493825 | Month 6: Whole tablet72493826 | Month 6: Dispersed tablet72493826 | Month 6: Dispersed tablet72493825 |
---|
| Negative response to palatability - No | Negative response to palatability - Yes |
---|
Ticagrelor 15/30/45 mg bd | 5 |
Placebo | 8 |
Ticagrelor 15/30/45 mg bd | 1 |
Placebo | 2 |
Placebo | 0 |
Ticagrelor 15/30/45 mg bd | 4 |
Placebo | 9 |
Placebo | 1 |
Ticagrelor 15/30/45 mg bd | 0 |
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Palatability of the Study Treatment Assessed by Facial Hedonic Scale (FHS) in Participants ≥5 Years of Age
"The FHS method was used for all participants taking the study treatment who are ≥5 years of age. The FHS consists of 5 faces with descriptions ranging from Dislike very much to Like very much. The face with description Like very much was considered as positive outcome. The way in which the study treatment was taken, that is, whether the tablet is whole or dispersed, was captured." (NCT03615924)
Timeframe: Baseline (randomization visit) and Month 6
Intervention | Participants (Count of Participants) | Participants (Count of Participants) |
---|
| Baseline: Whole tablet72493825 | Baseline: Whole tablet72493826 | Baseline: Dispersed tablet72493826 | Baseline: Dispersed tablet72493825 | Month 6: Whole tablet72493825 | Month 6: Whole tablet72493826 | Month 6: Dispersed tablet72493825 |
---|
| Like a little | Like very much | Dislike very much | Dislike a little | Not sure |
---|
Ticagrelor 15/30/45 mg bd | 3 |
Ticagrelor 15/30/45 mg bd | 4 |
Placebo | 2 |
Ticagrelor 15/30/45 mg bd | 12 |
Placebo | 8 |
Ticagrelor 15/30/45 mg bd | 25 |
Placebo | 23 |
Ticagrelor 15/30/45 mg bd | 48 |
Placebo | 45 |
Ticagrelor 15/30/45 mg bd | 0 |
Ticagrelor 15/30/45 mg bd | 1 |
Placebo | 1 |
Placebo | 0 |
Ticagrelor 15/30/45 mg bd | 5 |
Placebo | 3 |
Placebo | 4 |
Ticagrelor 15/30/45 mg bd | 30 |
Placebo | 20 |
Ticagrelor 15/30/45 mg bd | 44 |
Placebo | 47 |
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Fatigue Total Score Using Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
"The PedsQL multidimensional fatigue scale instrument developed using a 5-point Likert scale (where 0= never and 4= almost always) for the participant self-report forms for ages ≥5 to <8 years, ≥8 to <13 years, and ≥13 to ≤18 years and the caregiver proxy-report form specific for ≥2 to <5 years was used. The PedsQL multidimensional fatigue scale measures problems in the following categories:~General (6 items)~Sleep/rest (6 items)~Cognitive fatigue (6 items)~Total score (18 items) PedsQL multidimensional fatigue scale items were reverse-scored and linearly transformed to a 0 to 100 scale (0= 100, 1= 75, 2= 50, 3= 25, 4= 0) so that higher scores indicate better quality of life. To create the PedsQL multidimensional fatigue scale total score (18 items), the arithmetic mean of the transformed scores was computed as the sum of the items transformed scores divided by the number of items answered. Baseline values are closest observation prior to and including randomization visit." (NCT03615924)
Timeframe: For ages ≥2 to <5 years and ≥5 to <8 years: Baseline (observation prior to and including the randomization visit) and Months 6, and 12; For ages ≥8 to <13 years and ≥13 to ≤18 years: Baseline and Months 6, 12, and 18
Intervention | score on a scale (Mean) |
---|
| >=2 to <5 years: Baseline | >=2 to <5 years: Month 6 | >=5 to <8 years: Baseline | >=5 to <8 years: Month 6 | >=5 to <8 years: Month 12 | >=8 to <13 years: Baseline | >=8 to <13 years: Month 6 | >=8 to <13 years: Month 12 | >=8 to <13 years: Month 18 | >=13 to <=18 years: Baseline | >=13 to <=18 years: Month 6 | >=13 to <=18 years: Month 12 | >=13 to <=18 years: Month 18 |
---|
Ticagrelor 15/30/45 mg bd | 88.06 | 84.44 | 82.33 | 87.12 | 95.83 | 64.72 | 75.65 | 81.48 | 73.61 | 68.06 | 73.53 | 67.13 | 72.22 |
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Fatigue Total Score Using Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
"The PedsQL multidimensional fatigue scale instrument developed using a 5-point Likert scale (where 0= never and 4= almost always) for the participant self-report forms for ages ≥5 to <8 years, ≥8 to <13 years, and ≥13 to ≤18 years and the caregiver proxy-report form specific for ≥2 to <5 years was used. The PedsQL multidimensional fatigue scale measures problems in the following categories:~General (6 items)~Sleep/rest (6 items)~Cognitive fatigue (6 items)~Total score (18 items) PedsQL multidimensional fatigue scale items were reverse-scored and linearly transformed to a 0 to 100 scale (0= 100, 1= 75, 2= 50, 3= 25, 4= 0) so that higher scores indicate better quality of life. To create the PedsQL multidimensional fatigue scale total score (18 items), the arithmetic mean of the transformed scores was computed as the sum of the items transformed scores divided by the number of items answered. Baseline values are closest observation prior to and including randomization visit." (NCT03615924)
Timeframe: For ages ≥2 to <5 years and ≥5 to <8 years: Baseline (observation prior to and including the randomization visit) and Months 6, and 12; For ages ≥8 to <13 years and ≥13 to ≤18 years: Baseline and Months 6, 12, and 18
Intervention | score on a scale (Mean) |
---|
| >=2 to <5 years: Baseline | >=2 to <5 years: Month 6 | >=2 to <5 years: Month 12 | >=5 to <8 years: Baseline | >=5 to <8 years: Month 6 | >=5 to <8 years: Month 12 | >=8 to <13 years: Baseline | >=8 to <13 years: Month 6 | >=8 to <13 years: Month 12 | >=13 to <=18 years: Baseline | >=13 to <=18 years: Month 6 | >=13 to <=18 years: Month 12 |
---|
Placebo | 70.56 | 81.94 | 94.44 | 84.13 | 87.70 | 100.00 | 69.51 | 77.89 | 65.87 | 67.17 | 75.21 | 60.28 |
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ADP Induced Platelet Aggregation
We will use summary statistics to describe the distribution of the data. Post-treatment ADP-induced WBPA value in ohms (Ω) will be the primary outcome variable. We will use an analysis of covariance (ANCOVA) model to compare the treatment effects of ticagrelor vs. clopidogrel in CKD patients because this approach has higher statistical power than other methods to analyze drug effects. T (NCT03649711)
Timeframe: 2 weeks
Intervention | ohms (Median) |
---|
CKD-Ticagrelor | 0 |
CKD-Clopidogrel | 6 |
Control-ticagrelor | 1 |
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Platelet Surface P-selectin Expression
Platelet surface P-selectin expression was measured using flow cytometry before and after treatment. (NCT03649711)
Timeframe: 2 weeks
Intervention | Fluorescence intensity (Median) |
---|
CKD-Ticagrelor | 1002.5 |
CKD-Clopidogrel | 1037.5 |
Control-ticagrelor | 1052 |
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Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. (NCT03708588)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|
Experimental: Chewed Ticagrelor | 2 |
Active Comparator: Integral Pill | 0 |
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Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE)
Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. (NCT03708588)
Timeframe: 1 year
Intervention | Participants (Count of Participants) |
---|
Experimental: Chewed Ticagrelor | 4 |
Active Comparator: Integral Pill | 2 |
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Concentration of Pharmacodynamics
Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU. (NCT03708588)
Timeframe: 1 hour
Intervention | platelet reaction units (Median) |
---|
Experimental: Chewed Ticagrelor | 142.5 |
Active Comparator: Integral Pill | 210 |
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Percent of Patients With Insufficient Antiaggregation
The percent of patients with a high residual platelet reactivity (PRU > 208 by VerifyNow test), thus not adequately antiaggregated, 1 hour after Ticagrelor LD. (NCT03822377)
Timeframe: 1 hour
Intervention | Participants (Count of Participants) |
---|
Experimental Arm | 51 |
Control Arm | 53 |
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Number of Participants With Clinically Relevant Bleeding Events
Actionable bleeding events across the two different regimens of Ticagrelor administration, requiring diagnostic studies, hospitalization, or treatment by a health care professional (BARC type 2 or higher) (NCT03822377)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|
Ticagrelor Orodispersible Tablets | 0 |
Ticagrelor Standard Tablets | 4 |
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Number of Participants With Morphine-ticagrelor Interaction
Potential morphine-ticagrelor interaction will be assessed by stratified randomization according to morphine use (NCT03822377)
Timeframe: 6 hours
Intervention | Participants (Count of Participants) |
---|
Ticagrelor Orodispersible Tablets | 6 |
Ticagrelor Standard Tablets | 4 |
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Number of Participants With Residual Platelet Reactivity at Various Timepoints
Residual platelet reactivity (PRU) at 2, 4 and 6 hours measured by VerifyNow test to assess antiplatelet effect of P2Y12 inhibitors (NCT03822377)
Timeframe: 2, 4 and 6 hours
Intervention | Participants (Count of Participants) |
---|
Ticagrelor Orodispersible Tablets | 42 |
Ticagrelor Standard Tablets | 9 |
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Evaluation of Platelet Inhibition
"Platelet reactivity will be measured by VerifyNow test 1 hour after Ticagrelor loading dose (LD) administered as orodispersible tablets as compared with standard formulation in 130 patients with STEMI or very high-risk NSTEMI undergoing immediate PCI.~The VerifyNow PRU Test is designed to measure P2Y12 receptor blockade. Results of the PRU Tests are reported as P2Y12 Reaction Units (PRU). PRU measures the extent of platelet aggregation in the presence of a P2Y12 inhibitor. Lower PRU levels are associated with expected antiplatelet effect." (NCT03822377)
Timeframe: 1 hour
Intervention | P2Y12 Reaction Units (PRU) (Median) |
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Ticagrelor Orodispersible Tablets | 94 |
Ticagrelor Standard Tablets | 141 |
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Incidence of Adverse Events Occurring During Hospital Stay
Combined ticagrelor administration-related adverse events defined as in-hospital ≥2 BARC bleedings, dyspnea, ventricular pauses, allergic reactions, or vomit (NCT03822377)
Timeframe: Until discharge from the hospital (usually up to 7 days)
Intervention | Participants (Count of Participants) |
---|
Experimental Arm | 14 |
Control Arm | 15 |
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Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)
The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen (NCT04006288)
Timeframe: 30 days
Intervention | percentage of MPA (Median) |
---|
Aspirin and Clopidogrel | 27 |
Aspirin and Rivaroxaban From Aspirin and Clopidogrel | 53 |
Aspirin and Prasugrel | 20 |
Aspirin and Rivaroxaban From Aspirin and Prasugrel | 4 |
Aspirin and Ticagrelor | 15 |
Aspirin and Rivaroxaban From Aspirin and Ticagrelor | 20 |
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Number of Participants Experiencing Clinical Lab Abnormalities
The number of participants with abnormal clinical laboratory results. The criteria used for classifying laboratory test results as markedly abnormal is listed below. (NCT05093790)
Timeframe: From baseline up to 24 hours post dose
Intervention | Participants (Count of Participants) |
---|
| HEMOGLOBIN (G/DL)-Abnormal Low | HEMATOCRIT (%)-Abnormal Low | ERYTHROCYTES (X10*6 C/UL)-Abnormal Low | LEUKOCYTES (X10*3 C/UL)-Abnormal Low | LEUKOCYTES (X10*3 C/UL)-Abnormal High | NEUTROPHILS (ABSOLUTE) (X10*3 C/UL)-Abnormal Low | BLOOD UREA NITROGEN (MG/DL)-Abnormal High | POTASSIUM, SERUM (MEQ/L)-Abnormal Low | CHLORIDE, SERUM (MEQ/L)-Abnormal High | CALCIUM, TOTAL (MG/DL)-Abnormal Low | PHOSPHORUS, INORGANIC (MG/DL)-Abnormal Low | MAGNESIUM, SERUM (MEQ/L)-Abnormal Low | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal Low | GLUCOSE, FASTING SERUM (MG/DL)-Abnormal High | PROTEIN, TOTAL (G/DL) -Abnormal Low | ALBUMIN (G/DL)-Abnormal Low | CREATINE KINASE (U/L)-Abnormal High | PROTEIN, URINE (N/A)-Abnormal High | GLUCOSE, URINE (N/A)-Abnormal High | BLOOD, URINE (N/A)-Abnormal High | RBC, URINE (HPF)-Abnormal High | WBC, URINE (HPF)-Abnormal High |
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Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 1 |
,Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 2 | 2 | 1 | 0 | 1 | 0 | 3 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 1 | 0 | 0 |
,Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 2 | 1 |
,Arm 4: Heathy Participants | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
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Percent Change From Baseline in Thrombus Area
The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication. (NCT05093790)
Timeframe: Baseline, Day 1 hour 2, Day 2 hour 24
Intervention | Percent Change (Mean) |
---|
| On-treatment Day 1, Hour 2, Low Shear | On-treatment Day 1, Hour 2, High Shear | Post-treatment Day 2, Hour 24, Low Shear | Post-treatment Day 2, Hour 24, High Shear |
---|
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 10.0 | -23.0 | 20.7 | -4.8 |
,Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 538.6 | -18.4 | 579.6 | -3.5 |
,Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 104.2 | -24.2 | 31.0 | -10.6 |
,Arm 4: Heathy Participants | -14.9 | -27.7 | -2.5 | -23.0 |
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Number of Participants Experiencing Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. (NCT05093790)
Timeframe: From first dose up to 8 days post last dose
Intervention | Participants (Count of Participants) |
---|
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 6 |
Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 |
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 4 |
Arm 4: Heathy Participants | 1 |
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Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
The number of participants with abnormal electrocardiogram values. The criteria used for classifying electrocardiogram results as markedly abnormal is listed below. The 2-hour and 24-hour ECGs should are performed prior to the Badimon Chamber run. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. (NCT05093790)
Timeframe: Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing
Intervention | Participants (Count of Participants) |
---|
| PR INTERVAL, AGGREGATE (MSEC) Baseline <210 | PR INTERVAL, AGGREGATE (MSEC) Baseline >=210 | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <210 | PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=210 | QRS DURATION, AGGREGATE (MSEC) Baseline <120 | QRS DURATION, AGGREGATE (MSEC) Baseline >=120 | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 <120 | QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 >=120 | QT INTERVAL, AGGREGATE (MSEC) Baseline <500 | QT INTERVAL, AGGREGATE (MSEC) Baseline >=500 | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <500 | QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=500 | QTCF INTERVAL, AGGREGATE (MSEC) Baseline <450 | QTCF INTERVAL, AGGREGATE (MSEC) Baseline >=450 | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <450 | QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=450 |
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Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 5 | 0 | 4 | 1 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
,Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 6 | 0 | 5 | 1 | 6 | 0 | 6 | 0 | 6 | 0 | 6 | 0 | 6 | 0 | 5 | 1 |
,Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
,Arm 4: Heathy Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants Experiencing Abnormal Vital Signs
The number of participants with abnormal vital sign values. The criteria used for classifying vital sign results as markedly abnormal is listed below. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. For Treatment Arms 1, 2, and 3, a baseline chamber run was performed approximately 2 hours after background therapy (ticagrelor, aspirin, or ticagrelor + aspirin) and prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. For Treatment Arm 4, a baseline chamber run was performed prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. Participants received background therapy before the final chamber run, and the final chamber run was performed on Day 2, approximately 24 hours after BMS-986141 dosing. (NCT05093790)
Timeframe: Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2
Intervention | Participants (Count of Participants) |
---|
| DIASTOLIC BLOOD PRESSURE (MMHG) Day 1 > 90 AND CHANGE FROM BASELINE > 10 | DIASTOLIC BLOOD PRESSURE (MMHG) Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10 | DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run < 55 AND CHANGE FROM BASELINE < -10 | HEART RATE (BEATS/MIN) Day 1 HR < 55 AND CHANGE FROM BASELINE < -15 | HEART RATE (BEATS/MIN) Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | HEART RATE (BEATS/MIN) Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | HEART RATE (BEATS/MIN) 2 Hour Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | HEART RATE (BEATS/MIN) 2 Hour Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15 | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Day 1 | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Pre-Chamber Run | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Post-Chamber Run | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Pre-Chamber Run | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Post-Chamber Run | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Pre-Chamber Run | RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Post-Chamber Run | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 Day 1 Pre-Chamber Run | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Pre-Chamber Run | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Post-Chamber Run | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Pre-Chamber Run | SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Post-Chamber Run | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Day 1 | TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Pre-Chamber Run |
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Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141 | 2 | 2 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 5 | 2 | 2 | 1 | 0 | 1 | 1 | 2 | 0 | 0 | 1 | 1 |
,Arm 2: 75 mg Aspirin + 4 mg BMS-986141 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 3 | 4 | 2 | 3 | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
,Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 4 | 4 | 2 | 6 | 8 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
,Arm 4: Heathy Participants | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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