| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Comparative Study of The Efficacy and Safety of Direct Mechanical Thrombectomy Versus Bridging Therapy in Large Vessel Occlusion: An Egyptian Single-Center Experience [NCT05155540] | Phase 4 | 51 participants (Actual) | Interventional | 2019-07-01 | Completed |
| Extending the Time Window for Tenecteplase by Effective RecanalizatioN of bAsilar Artery occLusion in Patients With POSTerior Circulation Stroke (POST-ETERNAL) [NCT05105633] | Phase 2/Phase 3 | 688 participants (Anticipated) | Interventional | 2021-11-29 | Recruiting |
| Phase 2B Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B) [NCT00252239] | Phase 2 | 112 participants (Actual) | Interventional | 2005-11-30 | Terminated(stopped due to Slow enrollment) |
| Alteplase for Waking Onset STROKE [NCT01150266] | Phase 1 | 0 participants (Actual) | Interventional | 2011-08-31 | Withdrawn |
| Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism [NCT03988842] | Phase 4 | 4 participants (Actual) | Interventional | 2019-07-25 | Terminated(stopped due to COVID-19 pandemic) |
| Tissue Plasminogen Activator Dwells to Reduce Catheter-associated Thrombosis and Infection [NCT03672006] | Phase 2 | 20 participants (Actual) | Interventional | 2019-04-22 | Completed |
| Randomized Clinical Trial Comparing Intravenous Thrombolysis With Thrombectomy by the Penumbra™ System in Patients With Middle Cerebral Artery Stem Occlusion - Pilot Study [NCT01133223] | Phase 2 | 0 participants (Actual) | Interventional | 2010-05-31 | Withdrawn |
| Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema [NCT01141881] | | 0 participants | Interventional | 2009-05-31 | Terminated(stopped due to occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group) |
| The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion: a Prospective Randomized Trial [NCT03678090] | Phase 2 | 0 participants (Actual) | Interventional | 2018-12-01 | Withdrawn(stopped due to Local IRB recommended IND exemption from FDA, study timeline not able to be met.) |
| [NCT02120066] | | 22 participants (Actual) | Interventional | 2011-01-31 | Completed |
| An Open Label, Multicenter, Single-arm Trial to Assess Safety and Efficacy of Alteplase (Rt-PA) in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset [NCT02930837] | Phase 3 | 120 participants (Actual) | Interventional | 2016-11-15 | Completed |
| [NCT02135588] | Phase 1 | 10 participants (Anticipated) | Interventional | 2013-10-31 | Recruiting |
| Phase IIb Study Comparing Tenecteplase to Alteplase in Acute Ischemic Stroke Within 3 to 4.5 Hours From Symptom Onset [NCT02180204] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2015-01-31 | Withdrawn |
| Low Dose Catheter Directed Thrombolysis for Acute Intermediary-high Risk Pulmonary Embolism [NCT03854266] | Phase 2 | 60 participants (Anticipated) | Interventional | 2020-03-10 | Recruiting |
| Multicenter, Open Label, Randomized Comparative Trial of the Efficacy and Safety of a Single Bolus Recombinant Non-immunogenic Staphylokinase and Bolus-infusion of Alteplase in Patients With Massive Pulmonary Embolism (FORPE) [NCT04688320] | Phase 3 | 310 participants (Actual) | Interventional | 2020-12-15 | Completed |
| Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation (RVC) With tPA Infusion Confirmed by Intraoperative Angio-optical Coherence Tomography (Angio-OCT) for the Treatment of Central Retinal Vein Occlusion (CRVO). [NCT03417401] | Phase 1 | 0 participants (Actual) | Interventional | 2018-10-16 | Withdrawn(stopped due to organizationally not yet possible) |
| Intraventricular Tissue Plasminogen Activator in the Management of Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Pilot Study [NCT01098890] | Phase 2 | 12 participants (Anticipated) | Interventional | 2009-10-31 | Recruiting |
| Treatment Approach in Patients Diagnosed With Pulmonary Thromboembolism With Intermediate-High Risk Interms of Early Mortality After the Establisment of Ege Pulmonary Embolism Team [NCT05512702] | | 100 participants (Anticipated) | Observational | 2022-06-03 | Recruiting |
| An Open-label, Randomised, Parallel-group Comparison to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With AMI [NCT02182011] | Phase 3 | 49 participants (Actual) | Interventional | 2000-05-31 | Completed |
| Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase [NCT02474810] | | 35 participants (Actual) | Interventional | 2013-01-31 | Active, not recruiting |
| Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke [NCT04484558] | | 40 participants (Anticipated) | Observational | 2020-01-01 | Recruiting |
| CHemical OptImization of Cerebral Embolectomy in Patients With Acute Stroke Treated With Mechanical Thrombectomy 2 (CHOICE 2 TRIAL) [NCT05797792] | Phase 3 | 440 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
| Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (Microvascular COVID-19 Lung Vessels Obstructive Thromboinflammatory Syndrome (MicroCLOTS): A Multicentral Randomized Trial (AtTAC-trial) [NCT04453371] | Phase 3 | 0 participants (Actual) | Interventional | 2020-10-15 | Withdrawn(stopped due to Our local committee has denied the approval request) |
| Mechanical Opening Device Implantation Following Intravenous r-tPA and Recanalization Outcome Evaluation in Stroke Disease (MODIFIED) Trial [NCT02347358] | Phase 2 | 100 participants (Anticipated) | Interventional | 2015-02-28 | Not yet recruiting |
| Safe Implementation of Thrombolysis in Stroke - Monitoring Study (SITS-MOST) [NCT02229812] | | 6,475 participants (Actual) | Observational | 2002-12-31 | Completed |
| SITS-NEW Safe Implementation of Thrombolysis in Stroke in the Non EU-World: An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke [NCT02229890] | | 593 participants (Actual) | Observational | 2006-06-30 | Completed |
| A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial [NCT04430569] | Phase 3 | 650 participants (Anticipated) | Interventional | 2021-08-04 | Recruiting |
| Helping Stroke Patients With ThermoSuit Cooling [NCT02453373] | | 14 participants (Actual) | Interventional | 2017-01-25 | Terminated(stopped due to The study has achieved its objectives of showing feasibility, safety, and trend for improved mRS. FDA and LRS agreed that this study should be terminated, and that a new, PIVOTAL trial should be started.) |
| A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset [NCT03541668] | Phase 3 | 674 participants (Actual) | Interventional | 2018-05-18 | Completed |
| A Pilot Study Comparing the Clinical Efficacy and Bleeding Risk Between Low Dose and Standard Dose Intrapleural Tissue Plasminogen Activator for Pleural Infection [NCT05766124] | Phase 2/Phase 3 | 30 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
| Prospective, Multicenter, Open, End-point Blinded, Stratified Block Randomized, Parallel Positive Controlled Clinical Trial of Tenecteplase in Acute Ischemic Stroke With Large Vessel Occlusion Over Time Window [NCT04516993] | Phase 2 | 224 participants (Actual) | Interventional | 2021-09-28 | Completed |
| Interventional Management of Stroke (IMS) II Study [NCT00243906] | Phase 2 | 81 participants (Actual) | Interventional | 2003-01-31 | Completed |
| Regisry of the Stroke Patients in Assiut University Hospital [NCT03392792] | | 1 participants (Anticipated) | Interventional | 2018-12-30 | Not yet recruiting |
| [NCT02309970] | | 90 participants (Anticipated) | Observational | 2014-12-31 | Not yet recruiting |
| A Randomised, Double Blind, Placebo-controlled, Parallel Group Trial of Low-dose Adjunctive alTeplase During prIMary PCI [NCT02257294] | Phase 2 | 440 participants (Actual) | Interventional | 2016-03-31 | Completed |
| A Randomized Double-blind Controlled Study to Compare the Effectiveness of 1.0 Versus 2.0 mg Alteplase (tPA) Dosing in Restoring [NCT02225782] | | 150 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
| "The Treatment of Deep Vein Thrombosis (DVT) of the Lower Extremities With Low-Dose Alteplase: a Pilot Study" [NCT00082355] | Phase 2 | 30 participants (Actual) | Interventional | 2004-05-31 | Completed |
| A Prospective, Randomized, Double Blind, Controlled Trial to Evaluate Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Pleural Empyema [NCT01246453] | Phase 4 | 204 participants (Anticipated) | Interventional | 2003-12-31 | Completed |
| Extending the Time Window for Tenecteplase by Effective Reperfusion of peNumbrAL Tissue in Patients With Large Vessel Occlusion [NCT04454788] | Phase 3 | 740 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
| Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection: A Phase 2a Clinical Trial [NCT04357730] | Phase 2 | 50 participants (Actual) | Interventional | 2020-05-14 | Completed |
| Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC) [NCT03348826] | Phase 2 | 0 participants (Actual) | Interventional | 2020-06-01 | Withdrawn(stopped due to No participants were enrolled) |
| Phase 2 Study of Rt-PA Dose-effect Relationship on ICH Evacuation [NCT02472574] | Phase 2 | 108 participants (Anticipated) | Interventional | 2015-06-30 | Active, not recruiting |
| Evaluation of Collateral Vessels in Patients With Acute Ischemic Stroke Receiving Thrombolytic Therapy (Clinical and Radiological Study) [NCT03311386] | | 40 participants (Actual) | Observational | 2017-11-23 | Completed |
| IV vs. IA tPA (Activase) in Acute Ischemic Stroke With CTA Evidence of Major Vessel Occlusion [NCT00624000] | | 7 participants (Actual) | Interventional | 2004-03-31 | Completed |
| A Trial of Complete Percutaneous Pericardial Drainage Facilitated by Intrapericardial Alteplase Compared to Conventional Pericardiocentesis When Indicated in Adults With Large Pericardial Effusion Due to Tuberculous and Non-tuberculous Pericarditis [NCT02673879] | Phase 3 | 2,176 participants (Anticipated) | Interventional | 2016-02-29 | Recruiting |
| A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Intravenous Thrombolytic Therapy With Alteplase in Acute Ischemic Stroke [NCT05188417] | Phase 2 | 266 participants (Actual) | Interventional | 2021-12-09 | Active, not recruiting |
| Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset [NCT02854592] | | 4,000 participants (Actual) | Observational | 2017-04-01 | Completed |
| Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke: QuICR & OPTIMISE Registry Based Pragmatic Randomized Controlled Trial [NCT03889249] | Phase 3 | 1,600 participants (Actual) | Interventional | 2019-12-10 | Completed |
| A Phase III Multi-centre, Prospective, Randomised, Open Label, Blinded Endpoint (PROBE), Active-controlled Parallel Group Trial to Assess Efficacy and Safety of Tenecteplase Versus Alteplase in Chinese Patients With Acute Ischaemic Stroke Within 4.5 Hours [NCT04915729] | Phase 3 | 1,490 participants (Actual) | Interventional | 2021-06-22 | Completed |
| Protocol for Post Marketing Surveillance of Actilyse Vial [NCT02229799] | | 265 participants (Actual) | Observational | 2003-02-28 | Terminated |
| Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability [NCT02132689] | Phase 4 | 100 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Study of the OPTtimum Duration of Acoustic Pulse ThromboLYSis ProcEdure in the Treatment of Acute Submassive Pulmonary Embolism [NCT02396758] | Phase 4 | 131 participants (Actual) | Interventional | 2015-06-12 | Completed |
| Short Duration High Intensity Intrapleural Alteplase With Pulmozyme (DNase) in Pleural Infection Management- Single Centre Experience [NCT04915586] | | 30 participants (Actual) | Interventional | 2019-12-30 | Completed |
| A Phase 2 Safety, Dose-finding and Efficacy Study Evaluating Viscoelastic Testing (VET) Guided Tissue Plasminogen Activator (tPA) Treatment in Critically-ill Pro-thrombotic Acute Respiratory Failure [NCT05540834] | Phase 2 | 70 participants (Anticipated) | Interventional | 2022-05-18 | Recruiting |
| A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardi [NCT02181985] | Phase 3 | 5,989 participants (Actual) | Interventional | 2000-05-31 | Completed |
| Prospective Randomized Double-Blind Controlled Trial of Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis [NCT04806373] | Phase 4 | 136 participants (Anticipated) | Interventional | 2021-06-15 | Recruiting |
| Dual Thrombolytic Therapy With Mutant Pro-urokinase (M-pro-urokinase, HisproUK) and Low Dose Alteplase for Ischemic Stroke [NCT04256473] | Phase 2 | 200 participants (Actual) | Interventional | 2019-08-10 | Completed |
| Low Dose Thrombolysis, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism [NCT04088292] | Phase 3 | 210 participants (Anticipated) | Interventional | 2019-06-06 | Recruiting |
| New Acute Treatment for Stroke - The Effect of Remote PERconditioning [NCT00975962] | Phase 3 | 120 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator rhTNK-tPA) Thrombolysis for Acute Large Vessel Occlusion After Successful Mechanical Thrombectomy Recanalization -- A Multicenter, Prospective, Randomized, Open-label, Blinded [NCT05624190] | Phase 4 | 256 participants (Anticipated) | Interventional | 2022-12-31 | Not yet recruiting |
| Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial [NCT02767232] | Phase 3 | 0 participants (Actual) | Interventional | 2018-07-31 | Withdrawn(stopped due to Did not receive NIH Funding) |
| Phase II Study to Assess the Safety, Imaging, Pharmacodynamic and Clinical Outcomes of Acute Ischemic Stroke Subjects Treated With tPA and THR-18 [NCT02572336] | Phase 2 | 40 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
| Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China [NCT03997292] | | 0 participants (Actual) | Observational | 2018-03-01 | Withdrawn(stopped due to The study has been terminated due to key change of protocol) |
| Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III [NCT00784134] | Phase 3 | 500 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke [NCT00640367] | Phase 3 | 350 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Efficacy and Safety Evaluation of Low Dosage of Recombinant Tissue Plasminogen Activator (rt-PA) in the Treatment of Pulmonary Thromboembolism: A Multi-Center, Randomized Controlled Trial in China [NCT00781378] | Phase 4 | 118 participants (Actual) | Interventional | 2002-06-30 | Completed |
| Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke [NCT03192332] | | 410 participants (Actual) | Interventional | 2017-11-29 | Completed |
| A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis [NCT01478698] | Phase 1 | 5 participants (Actual) | Interventional | 2016-01-01 | Terminated(stopped due to Insufficient budget for further study agents) |
| Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study [NCT03966079] | Phase 3 | 50 participants (Actual) | Interventional | 2017-01-01 | Completed |
| Efficacy and Safety of Thrombolytic Therapy With Half Dose Alteplase, Added to Standard Anticoagulation Therapy With Heparine, in Patients With Moderate Pulmonary Embolism: a Prospective, Randomized, Open Label,Controlled Trial [NCT02604238] | Phase 3 | 130 participants (Anticipated) | Interventional | 2016-03-31 | Not yet recruiting |
| [NCT00000472] | Phase 3 | 0 participants | Interventional | 1989-04-30 | Completed |
| [NCT00000468] | Phase 3 | 0 participants | Interventional | 1988-04-30 | Completed |
| Extending the Time for Thrombolysis in Emergency Neurological Deficits [NCT00887328] | Phase 3 | 180 participants (Actual) | Interventional | 2010-06-30 | Completed |
| Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema [NCT00468104] | | 100 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Phase 1 Trial of Intra-Ophthalmic Artery Thrombolysis for Treating Recent Severe Central Retinal Vein Occlusion [NCT01581411] | Phase 1 | 1 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation [NCT00224770] | Phase 2 | 141 participants (Actual) | Interventional | 2005-08-31 | Completed |
| Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone [NCT00359424] | Phase 3 | 656 participants (Actual) | Interventional | 2006-08-31 | Terminated(stopped due to NINDS/NIH-DSMB recommended halting trial due to futility, no safety concerns.) |
| The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis [NCT01062698] | | 412 participants (Actual) | Interventional | 2010-06-30 | Terminated(stopped due to Efficacy) |
| Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage [NCT01878136] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2015-03-31 | Withdrawn(stopped due to Time constraints) |
| EARLY Routine Catheterization or Rescue Angioplasty After Alteplase Fibrinolysis vs. Primary Angioplasty in Acute ST-elevation MYOcardial Infarction: An Open, Prospective, Randomized, Multicentre Trial [NCT01930682] | Phase 4 | 344 participants (Actual) | Interventional | 2014-01-13 | Completed |
| Randomised Trial of Tenecteplase vs. Alteplase for Recanalisation in Acute Ischemic Stroke [NCT01949948] | Phase 3 | 1,050 participants (Actual) | Interventional | 2012-09-30 | Completed |
| [NCT01956955] | Phase 4 | 150 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
| THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS) [NCT02002325] | Phase 3 | 300 participants (Anticipated) | Interventional | 2014-05-31 | Active, not recruiting |
| Peripheral Low Dose Systemic Thrombolysis Versus Catheter Directed Acoustic Pulse Thrombolysis for Treatment of Submassive Pulmonary Embolism [NCT03581877] | Phase 4 | 31 participants (Actual) | Interventional | 2019-01-28 | Completed |
| Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial [NCT02016547] | Phase 4 | 40 participants (Anticipated) | Interventional | 2013-09-30 | Terminated |
| Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism: AYKAN Trial [NCT02029456] | Phase 4 | 30 participants (Anticipated) | Interventional | 2011-06-30 | Recruiting |
| Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial [NCT02216565] | | 2 participants (Actual) | Interventional | 2014-12-01 | Terminated(stopped due to After results of other studies published : EASY study became lapsed) |
| Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China a Real-world, Multicenter, Retrospective, Controlled Study [NCT06078995] | | 1,200 participants (Anticipated) | Observational | 2023-04-02 | Recruiting |
| Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion in the Posterior Circulation (IAT-TOP) [NCT05897554] | | 376 participants (Anticipated) | Interventional | 2023-08-11 | Recruiting |
| Evaluation of Thrombolytic Therapy in Acute Ischemic Stroke Outcome: A Cohort Study From North of Iran [NCT04309357] | | 214 participants (Actual) | Observational | 2017-01-01 | Completed |
| A Phase II Clinical Study to Evaluate the Efficacy and Safety of Thrombolytic Therapy With Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism [NCT04110275] | Phase 2 | 174 participants (Anticipated) | Interventional | 2019-10-31 | Not yet recruiting |
| Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST 2) [NCT02814409] | Phase 3 | 1,870 participants (Anticipated) | Interventional | 2016-12-15 | Recruiting |
| SYNTHESIS: a Randomized Controlled Trial on Intra-arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke. Start up Phase. [NCT00540527] | Phase 3 | 54 participants (Actual) | Interventional | 2004-01-31 | Completed |
| Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study [NCT02894138] | Phase 3 | 80 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
| An International Randomised Controlled Trial to Establish the Effects of Low-dose rtPA and the Effects of Early Intensive Blood Pressure Lowering in Patients With Acute Ischaemic Stroke [NCT01422616] | Phase 3 | 4,587 participants (Actual) | Interventional | 2012-03-31 | Completed |
| PATCAR Pilot Trial: A Phase 4 Study, Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization [NCT00178620] | Phase 4 | 390 participants (Actual) | Interventional | 2003-09-30 | Completed |
| EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study [NCT05189509] | Phase 2 | 100 participants (Actual) | Interventional | 2022-02-11 | Completed |
| A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE [NCT06184321] | | 30 participants (Anticipated) | Observational | 2023-08-17 | Recruiting |
| A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion [NCT03197194] | Phase 3 | 70 participants (Anticipated) | Interventional | 2018-06-08 | Active, not recruiting |
| Improving Patient Access to Stroke Therapy Study [NCT01870492] | | 500 participants (Actual) | Observational | 2014-01-31 | Terminated(stopped due to Principle Investigator relocated to a new institution) |
| A Randomised Open-Label Controlled Trial of Pleural Irrigation With Normal Saline Versus Intrapleural Tissue Plasminogen Activator and DNase (Fibrinolytic Therapy) in Pleural Infection. [NCT05903417] | | 78 participants (Anticipated) | Interventional | 2023-07-10 | Recruiting |
| Intraventricular Fibrinolysis Versus External Ventricular Drainage Alone in Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial. [NCT03187405] | Phase 3 | 440 participants (Anticipated) | Interventional | 2018-02-21 | Recruiting |
| Safe Implementation of Treatments in Stroke (SITS) - Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Over 80 Years, SITS-IVT>80 Years Study [NCT04260347] | | 1,655 participants (Actual) | Observational | 2020-05-14 | Completed |
| Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Severe Pleural Infection: A Randomized Clinical Trial [NCT03213834] | Phase 4 | 5 participants (Actual) | Interventional | 2017-09-14 | Completed |
| A Randomized Controlled Trial of Intra-arterial Reperfusion Therapy After Standard Dose Intravenous t-PA Within 4.5 Hours of Stroke Onset Utilizing Dual Target Imaging Selection. [NCT01492725] | Phase 2 | 70 participants (Actual) | Interventional | 2012-06-30 | Terminated(stopped due to On DSMB advice, trial recruitment has been halted for efficacy. F/U continues) |
| Multicenter Open Label Randomized Comparative Study of Efficacy and Safety of Single Bolus Injection of Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase (Actilyse) in Patients With Acute Ischemic Stroke [NCT03151993] | Phase 3 | 336 participants (Actual) | Interventional | 2017-03-18 | Completed |
| Sonothrombolysis Potentiated by Microbubbles as a Novel Treatment of Acute Ischemic Stroke: a Prospective Randomized Pilot Study [NCT01678495] | Phase 2 | 24 participants (Actual) | Interventional | 2012-08-31 | Completed |
| Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial [NCT00790335] | Phase 3 | 692 participants (Actual) | Interventional | 2009-11-30 | Completed |
| A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial [NCT04797013] | Phase 3 | 1,430 participants (Actual) | Interventional | 2021-06-12 | Completed |
| Intravitreal Tissue Plasminogen Activator And Perfluoropropane for Neovascular Age-related Macular Degeneration With Associated Submacular Haemorrhage: a Multi-centre, Randomized, Double-masked, Sham-controlled, Factorial, Feasibility Study [NCT01835067] | Phase 2/Phase 3 | 55 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis - Pilot Phase (ATTEST) [NCT01472926] | Phase 2 | 104 participants (Actual) | Interventional | 2011-12-31 | Completed |
| Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) in Acute Stroke [NCT00238537] | Phase 2 | 100 participants | Interventional | 2001-08-31 | Completed |
| Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers [NCT04419493] | Phase 1 | 30 participants (Actual) | Interventional | 2020-06-23 | Completed |
| Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion [NCT00103766] | | 75 participants | Interventional | 2004-10-31 | Recruiting |
| Early Reperfusion Therapy With Intravenous Alteplase for Recovery of VISION in Acute Central Retinal Artery Occlusion [NCT04965038] | Phase 3 | 1,400 participants (Anticipated) | Interventional | 2022-10-10 | Recruiting |
| Enhancing DCD Utilization With Thrombolytic Therapy [NCT01197573] | | 103 participants (Actual) | Interventional | 2010-04-30 | Completed |
| MR WITNESS: A Phase IIa Safety Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients [NCT01282242] | Phase 2 | 88 participants (Actual) | Interventional | 2011-01-31 | Completed |
| The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke [NCT01429350] | Phase 4 | 108 participants (Actual) | Interventional | 2012-05-31 | Completed |
| ALteplase for the Treatment of Acute Ischemic Stroke in Patients With LOW National Institutes of Health Stroke Scale and Specified Disabling Deficits [NCT06115070] | Phase 4 | 300 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA [NCT03452722] | | 88 participants (Actual) | Observational | 2011-06-01 | Completed |
| Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction? [NCT03451903] | | 106 participants (Actual) | Observational | 2015-01-01 | Completed |
| The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study [NCT05491356] | Phase 4 | 40 participants (Anticipated) | Interventional | 2023-05-11 | Recruiting |
| Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke (BRAIS)：a Pilot, Prospective, Random, and Double Blinded Multi-center Study [NCT03394950] | Phase 4 | 120 participants (Actual) | Interventional | 2018-05-25 | Completed |
| Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke: a Randomised, Double-blind, Placebo-controlled Trial [NCT01525290] | Phase 3 | 501 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Low Dose Rt-PA Plus LMWH Compared With LMWH Alone for the Treatment of Normotensive Pulmonary Embolism Patients With Acute RV Dysfunction: A Randomized，Multi-Center，Controlled Trial [NCT01531829] | Phase 4 | 460 participants (Anticipated) | Interventional | 2009-07-31 | Recruiting |
| Treatment of Jugular, Subclavian, and/or Innominate Vein Thrombosis With Low Dose Recombinant Tissue Plasminogen Activator Plus Anticoagulation [NCT00055159] | Phase 1 | 50 participants | Interventional | 2003-02-19 | Completed |
| Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study [NCT00029315] | Phase 2 | 30 participants (Anticipated) | Interventional | 2001-09-30 | Completed |
| A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo [NCT00044057] | Phase 2 | 0 participants | Interventional | 2000-12-31 | Completed |
| Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Phase 4) [NCT00412867] | Phase 4 | 58 participants (Actual) | Interventional | 2006-12-31 | Completed |
| Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial Using Intravenous Tenecteplase [NCT02388061] | Phase 2 | 202 participants (Actual) | Interventional | 2015-03-23 | Completed |
| Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction [NCT03335839] | Phase 3 | 200 participants (Anticipated) | Interventional | 2018-04-01 | Recruiting |
| Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA - PROCOPrt-PA Trial [NCT01670474] | Phase 4 | 240 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
| Early Successful Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes [NCT05635786] | | 172 participants (Actual) | Observational | 2023-01-02 | Completed |
| Extending the Time for Thrombolysis in Emergency Neurological Deficits [NCT01580839] | Phase 3 | 45 participants (Actual) | Interventional | 2012-12-06 | Completed |
| Dose-Ranging, Safety And Efficacy Of Cathflo(TM) Activase(R) (Alteplase) For The Treatment Of Central Catheter Occlusion In Neonates And Infants; Phase I [NCT00265005] | Phase 1 | 12 participants (Actual) | Interventional | 2005-06-30 | Terminated(stopped due to difficulty in recruiting subjects) |
| Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial [NCT00250991] | Phase 1/Phase 2 | 94 participants (Actual) | Interventional | 2003-07-31 | Completed |
| Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial [NCT00417768] | Phase 2/Phase 3 | 35 participants (Actual) | Interventional | 2005-07-31 | Terminated(stopped due to Change in patient population no longer fit study criteria.) |
| Phase 1 Study of Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke [NCT00283088] | Phase 1 | 130 participants (Anticipated) | Interventional | 2003-10-31 | Completed |
| Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial [NCT00303420] | Phase 4 | 180 participants (Anticipated) | Interventional | 2004-09-30 | Terminated(stopped due to Unable to enrol enough people to achieve the full sample size) |
| Cathflo Activase (Alteplase) Pediatric Study (CAPS) [NCT00307580] | Phase 4 | 300 participants | Interventional | 2002-04-30 | Completed |
| A Randomised Controlled Clinical Trial of Adjunctive Mechanical Thrombectomy Compared With Intravenous Thrombolysis in Patients With Acute Ischaemic Stroke Due to an Occluded Major Intracranial Vessel. [NCT01745692] | | 65 participants (Actual) | Interventional | 2012-12-31 | Terminated(stopped due to IDMC decision - recommended on basis of results from other relevant clinical trials, there were not safety concerns) |
| The Feasibility and Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window in China [NCT01770197] | | 200 participants (Anticipated) | Observational [Patient Registry] | 2008-01-31 | Enrolling by invitation |
| A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs) [NCT03594175] | Phase 3 | 462 participants (Actual) | Interventional | 2020-02-12 | Terminated(stopped due to Due to ongoing recruitment challenges globally, it is not possible to complete this study. The decision is not based on any reported changes in the safety profile or any concerns with the anticipated efficacy profile of the investigational product.) |
| The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days o [NCT04640194] | Phase 2/Phase 3 | 104 participants (Actual) | Interventional | 2020-12-16 | Terminated(stopped due to Sponsor decision) |
| Intrapleural Tissue Plasminogen Activator and Deoxyribonuclease Therapy Versus Early Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial [NCT03468933] | Phase 4 | 32 participants (Actual) | Interventional | 2017-11-01 | Completed |
| Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial) [NCT01717742] | Phase 3 | 97 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Tissue Plasminogen Activator (tPA) Therapy for Acute Ischemic Stroke in Covid -19 and Non Covid -19 Patients [NCT05258565] | Phase 1 | 50 participants (Actual) | Interventional | 2022-03-01 | Completed |
| Treatment of Acute Deep Vein Thrombosis of the Lower Extremity With Intraclot, Pulse-Sprayed Recombinant Tissue Plasminogen Activator, Plus Heparin and Warfarin: A Pilot Study [NCT00001713] | Phase 1 | 20 participants | Interventional | 1998-02-28 | Completed |
| Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis [NCT01451320] | | 182 participants (Actual) | Interventional | 1993-01-31 | Completed |
| A Randomised Trial of Tenecteplase vs. Alteplase in Acute Ischemic Stroke [NCT03854500] | Phase 3 | 201 participants (Actual) | Interventional | 2019-10-28 | Terminated(stopped due to Per protocol safety analysis 200 patients showed a significant difference in bleeding rates between the two drug groups.) |
| Predictors of the Unfavourable Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase, a Multi-centre Prospective Study [NCT06058884] | Phase 4 | 592 participants (Actual) | Interventional | 2022-01-03 | Completed |
| A Pilot, Open Label, Phase II Clinical Trial of Nebulised Recombinant Tissue-Plasminogen Activator (Rt-PA) [NCT04356833] | Phase 2 | 66 participants (Anticipated) | Interventional | 2020-04-22 | Recruiting |
| A Phase 2, Randomized, Open-label (With Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With [NCT01222117] | Phase 2 | 174 participants (Actual) | Interventional | 2010-12-31 | Completed |
| CHemical OptImization of Cerebral Embolectomy in Patients With Acute Stroke Treated With Mechanical Thrombectomy (CHOICE) Trial [NCT03876119] | Phase 2/Phase 3 | 121 participants (Actual) | Interventional | 2018-12-05 | Completed |
| Safety of Intravenous Thrombolysis for Wake-up Stroke [NCT01183533] | Phase 2 | 40 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial [NCT05910125] | Phase 4 | 472 participants (Anticipated) | Interventional | 2023-07-31 | Not yet recruiting |
| Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial [NCT01455935] | Phase 2 | 90 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
| Phase I/II Trial of In Vivo Angiostatin Generation With Tissue Plasminogen Activator (tPA) and Captopril in Patients With Progressive, Metastatic Cancer [NCT00086723] | Phase 1/Phase 2 | 0 participants | Interventional | 2003-07-31 | Completed |
| EXtending the Time Window for Thrombolysis in Posterior Circulation Stroke Without Early CT Signs [NCT05429476] | Phase 3 | 233 participants (Anticipated) | Interventional | 2022-08-17 | Recruiting |
| ARTSS-2: A Pilot, Phase 2b, Randomized, Multi-center Trial of Argatroban in Combination With Recombinant Tissue Plasminogen Activator for Acute Stroke [NCT01464788] | Phase 2 | 90 participants (Actual) | Interventional | 2011-10-31 | Terminated(stopped due to The study was halted prematurely at 90 of 105 planned patients due to the beneficial results of embolectomy clinical trials.) |
| A Double Blind, Randomized Controlled Trial Examining the Efficacy of the Use of Tissue Plasminogen Activator (tPA) in Intra-abdominal Collections in Children - a Prospective Study [NCT01576679] | Phase 3 | 28 participants (Actual) | Interventional | 2012-03-31 | Terminated(stopped due to very slow accrual.) |
| Treatment of Abdominal Abscesses With or Without Fibrinolysis [NCT01597336] | | 92 participants (Anticipated) | Interventional | 2009-06-30 | Completed |
| The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute ST Elevation Myocardial Infarction(STEMI): a Multi-center, Randomized, Open, Parallel, Non-inferiority, Active Controlled Trial [NCT02835534] | Phase 4 | 818 participants (Actual) | Interventional | 2016-05-31 | Completed |
| [NCT00000505] | Phase 3 | 0 participants | Interventional | 1983-04-30 | Completed |
| ACCElerated ThrombolySiS for Post-Thrombotic Syndrome Using the EKOS System [NCT02159521] | Phase 4 | 81 participants (Actual) | Interventional | 2014-07-10 | Completed |
| A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS) [NCT02072226] | Phase 3 | 313 participants (Actual) | Interventional | 2014-05-31 | Terminated(stopped due to The study was terminated due to slow enrollment.) |
| Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III [NCT01827046] | Phase 3 | 499 participants (Actual) | Interventional | 2013-12-30 | Completed |
| Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial [NCT05856851] | Phase 3 | 324 participants (Anticipated) | Interventional | 2023-08-01 | Recruiting |
| "Quality and Effectiveness of Thrombolytic Care During Inter-hospital Transfer (Drip-Ship) With Air Ambulance Services" [NCT02752256] | | 76 participants (Actual) | Observational | 2015-10-31 | Completed |
| Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses [NCT00284739] | Phase 2 | 20 participants (Actual) | Interventional | 2006-02-28 | Completed |
| An Open, Prospective, Blinded Evaluation, International, Multicentre, Controlled Study of Safety and Efficacy of Thrombectomy and Standard Stroke Care in Clinical Routine Treatment of Acute Occlusive Stroke Compared to Standard Stroke Care Only [NCT02326428] | | 341 participants (Actual) | Interventional | 2014-03-31 | Completed |
| A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [NCT01513759] | Phase 3 | 150 participants (Actual) | Interventional | 2012-06-07 | Completed |
| TOP-TRIAL The Safety of Not Flushing the Non-used PORT-A-CATH® in Cancer Patients - a Prospective, Two-arm Phase I Trial, Pilot Trial [NCT02492477] | Phase 1 | 4 participants (Actual) | Interventional | 2016-01-31 | Terminated(stopped due to poor recruitment) |
| A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism [NCT03108833] | Phase 2 | 108 participants (Actual) | Interventional | 2017-06-06 | Completed |
| A Phase III, Multicenter, Randomized, Blind Endpoint and Positive Drug Control Study of Recombinant Human Tissue Plasminogen Kinase Derivatives for Injection in the Treatment of Patients With Acute Ischemic Stroke [NCT05295173] | Phase 3 | 1,412 participants (Actual) | Interventional | 2022-03-21 | Completed |
| Thrombolysis Treated by TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Control and Non-inferior Phase Ⅲ Trial, 3T Stroke-Ⅲ [NCT05745259] | Phase 3 | 1,630 participants (Anticipated) | Interventional | 2022-10-26 | Recruiting |
| A Multicenter, Open-label, Randomised, Clinical Trial to Compare the Efficacy and Safety of Actilyse 2 mg/ 2 ml Versus Saline Solution in Restoring Function of an Occluded Central Venous Access Device [NCT01958164] | Phase 3 | 16 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Application of tPA in Suprachoroidal and Subretinal Hemorrhage [NCT05736757] | | 20 participants (Anticipated) | Interventional | 2022-12-01 | Recruiting |
| Safety and Efficacy of Inhaled Tissue Plasminogen Activator (tPA) for the Acute Treatment of Pediatric Plastic Bronchitis [NCT02315898] | Phase 2 | 40 participants (Actual) | Interventional | 2018-03-19 | Completed |
| A PhaseⅡ, Multicenter, Prospective Randomised, Open Blinded Endpoint Study to Evaluate Safety and Efficacy of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke. [NCT04028518] | Phase 2 | 180 participants (Anticipated) | Interventional | 2019-07-20 | Not yet recruiting |
| A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention [NCT00046228] | Phase 3 | 2,461 participants (Actual) | Interventional | 2002-08-31 | Completed |
| Japan Alteplase Clinical Trial (J-ACT): Phase 3 Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Acute Ischemic Stroke Within 3 Hours of Onset [NCT00147316] | Phase 3 | 103 participants (Actual) | Interventional | 2002-04-30 | Completed |
| Thrombolysis in Ischemic Spinal Cord Stroke [NCT02242084] | Phase 2 | 12 participants (Actual) | Interventional | 2016-04-30 | Terminated |
| The Prevalence and Associated Factors of Early Neurological Deterioration After Successful Recanalization Treatment in Patients With Acute Ischemic Stroke [NCT04978181] | | 30 participants (Anticipated) | Observational | 2021-08-01 | Not yet recruiting |
| Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Controlled Phase II Trial [NCT05281549] | Phase 2 | 225 participants (Anticipated) | Interventional | 2021-05-02 | Active, not recruiting |
| Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial [NCT01657461] | | 196 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial. [NCT05728333] | Phase 2/Phase 3 | 800 participants (Anticipated) | Interventional | 2023-03-01 | Not yet recruiting |
| Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH) [NCT00650858] | Phase 2 | 52 participants (Actual) | Interventional | 2004-02-29 | Completed |
| Safety of Intravenous Thrombolytics in Stroke on Awakening [NCT01643902] | Phase 2 | 20 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction [NCT04571580] | Phase 3 | 36 participants (Actual) | Interventional | 2021-07-01 | Terminated(stopped due to The study enrollment is slow due to the pandemic.) |
| A Multicentre, Feasibility Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®). Pre-Hospital Alteplase Remote Advice of Hospi [NCT02235389] | | 59 participants (Actual) | Observational | 1998-02-28 | Terminated |
| Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance [NCT04071613] | Phase 2 | 104 participants (Actual) | Interventional | 2019-06-20 | Completed |
| Argatroban Plus R-tPA for Acute Posterior Circulation Infarction (AR-PCI): a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study [NCT03506009] | Phase 4 | 3 participants (Actual) | Interventional | 2018-07-11 | Terminated(stopped due to it is very difficult to recruit qualified patients) |
| Catheter-Directed Thrombolysis Versus ANticoagulation Monotherapy in Patients With Acute Intermediate-High Risk PulmonarY Embolism: The CANARY Randomized Clinical Trial [NCT05172115] | Phase 3 | 94 participants (Actual) | Interventional | 2018-12-22 | Terminated(stopped due to Due to the COVID-19 pandemic) |
| A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis [NCT03357133] | Phase 2/Phase 3 | 30 participants (Actual) | Interventional | 2017-12-16 | Terminated(stopped due to The number and speed of enrollment were significantly less than expected.) |
| Dual IntraVenous Thrombolysis Approach (DIVA) in Patients With Medium-vessel-occlusion Strokes: a Retrospective Study [NCT05809921] | | 294 participants (Actual) | Observational | 2023-05-17 | Completed |
| Efficacy of Simultaneous Infusion of Tirofiban With Intravenous Thrombolysis in Patients With Acute Anterior Choroidal Infarction or Paramedian Pontine Infarction [NCT05733507] | | 48 participants (Actual) | Observational | 2023-04-03 | Completed |
| Vitrectomy, Subretinal Tissue Plasminogen Activator and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative Age-Related Macular Degeneration (TIGER): a Phase 3, Pan-European, Two-group, Observer-masked, Superiority, Randomised Controlled Su [NCT04663750] | Phase 3 | 210 participants (Anticipated) | Interventional | 2021-04-16 | Recruiting |
| Endovascular Treatment With Or Without Intravenous Alteplase In Acute Ischemic Stroke Of Basilar Artery Occlusion: A Multicenter, Prospective, Randomized Controlled Trial (BEST-BAO) [NCT05631847] | | 336 participants (Anticipated) | Interventional | 2023-01-15 | Not yet recruiting |
| Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke: a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study [NCT03661411] | Phase 4 | 760 participants (Actual) | Interventional | 2018-10-17 | Completed |
| Treatment With Intravenous Alteplase in Ischemic Stroke Patients With Onset Time Between 4.5 and 24 Hours [NCT04879615] | Phase 3 | 372 participants (Anticipated) | Interventional | 2021-06-21 | Recruiting |
| Assessing the Impact of Care in A Telemedicine-based Stroke Network Using Patient-Centered Health Related Quality of Life Outcomes [NCT02447094] | | 300 participants (Anticipated) | Observational | 2015-02-28 | Recruiting |
| Thrombolysis in Pediatric Stroke (TIPS) [NCT01591096] | Phase 1 | 1 participants (Actual) | Interventional | 2012-10-31 | Terminated(stopped due to Lack of patient accrual) |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00046228 (10) [back to overview] | All-Cause Mortality Through 1 Year |
| NCT00046228 (10) [back to overview] | All-Cause Mortality Through 90 Days |
| NCT00046228 (10) [back to overview] | Complications of MI as Defined in the Primary Outcome Measure Through 90 Days |
| NCT00046228 (10) [back to overview] | Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7 |
| NCT00046228 (10) [back to overview] | Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7 |
| NCT00046228 (10) [back to overview] | The Composite of All-Cause Mortality or Complications of MI at 90 Days. |
| NCT00046228 (10) [back to overview] | Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization |
| NCT00046228 (10) [back to overview] | Subjects With Severe Thrombocytopenia Through Discharge/Day 7 |
| NCT00046228 (10) [back to overview] | Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7 |
| NCT00046228 (10) [back to overview] | Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7 |
| NCT00082355 (2) [back to overview] | Number of Participants With Restored Venous Function |
| NCT00082355 (2) [back to overview] | Number of Participants That Developed Hemorrhage |
| NCT00147316 (2) [back to overview] | Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours |
| NCT00147316 (2) [back to overview] | Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months |
| NCT00178620 (1) [back to overview] | Mortality at 30 Days |
| NCT00224770 (9) [back to overview] | Ordinal Modified Rankin Scale (mRS) at Day 180 |
| NCT00224770 (9) [back to overview] | Ordinal Modified Rankin Scale (mRS) at Day 365 |
| NCT00224770 (9) [back to overview] | Post-operative Clot Size Reduction |
| NCT00224770 (9) [back to overview] | Safety Outcome Number 1: Rate of Mortality |
| NCT00224770 (9) [back to overview] | Safety Outcome Number 2: Rate of Procedure-related Mortality |
| NCT00224770 (9) [back to overview] | Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180 |
| NCT00224770 (9) [back to overview] | Safety Outcome Number 4: Rate of Symptomatic Rebleeding |
| NCT00224770 (9) [back to overview] | Clot Size Reduction by End of Treatment |
| NCT00224770 (9) [back to overview] | Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis |
| NCT00252239 (1) [back to overview] | Functional Handicap (Modified Rankin Score) |
| NCT00284739 (3) [back to overview] | Duration (in Days) of Percutaneous Drainage. |
| NCT00284739 (3) [back to overview] | Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement |
| NCT00284739 (3) [back to overview] | Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage |
| NCT00359424 (13) [back to overview] | Incidence of Parenchymal Type II (PH2) Hematomas |
| NCT00359424 (13) [back to overview] | Symptomatic Intracranial Hemorrhage |
| NCT00359424 (13) [back to overview] | Trail Making Test Part A Time |
| NCT00359424 (13) [back to overview] | Trail Making Test Part B Time |
| NCT00359424 (13) [back to overview] | Barthel Index (BI) Dichotomized 0-90 Versus 95-100 |
| NCT00359424 (13) [back to overview] | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 |
| NCT00359424 (13) [back to overview] | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 |
| NCT00359424 (13) [back to overview] | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 |
| NCT00359424 (13) [back to overview] | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. |
| NCT00359424 (13) [back to overview] | National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater. |
| NCT00359424 (13) [back to overview] | National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater. |
| NCT00359424 (13) [back to overview] | Asymptomatic Intracranial Hemorrhage |
| NCT00359424 (13) [back to overview] | Death Due to Any Cause |
| NCT00412867 (6) [back to overview] | Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA) |
| NCT00412867 (6) [back to overview] | National Institutes of Health Stroke Scale (NIHSS) Score |
| NCT00412867 (6) [back to overview] | Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours |
| NCT00412867 (6) [back to overview] | Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months |
| NCT00412867 (6) [back to overview] | Barthel Index (BI) |
| NCT00412867 (6) [back to overview] | Percentage of Participants With Adverse Events and Adverse Drug Reactions |
| NCT00468104 (1) [back to overview] | No Surgical Intervention |
| NCT00650858 (8) [back to overview] | Rate of Symptomatic Bleeding Events |
| NCT00650858 (8) [back to overview] | 30-day Mortality |
| NCT00650858 (8) [back to overview] | Average Daily Percentage Clot Size Resolution Over the First 3 Days |
| NCT00650858 (8) [back to overview] | Incidence of Bacterial Ventriculitis, Meningitis |
| NCT00650858 (8) [back to overview] | 90 Day Follow-Up Glasgow Outcome Scale (GOS) Score |
| NCT00650858 (8) [back to overview] | 180 Day Follow-Up Glasgow Outcome Scale (GOS) Score |
| NCT00650858 (8) [back to overview] | 180 Day Follow-Up Modified Rankin Scale (mRS) Score |
| NCT00650858 (8) [back to overview] | 90 Day Follow-Up Modified Rankin Scale (mRS) Score |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) |
| NCT00784134 (46) [back to overview] | Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - Mechanical Ventilation |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) |
| NCT00784134 (46) [back to overview] | Adverse and Serious Adverse Events |
| NCT00784134 (46) [back to overview] | All Cause Mortality |
| NCT00784134 (46) [back to overview] | Clot Removal (Amount of Residual Blood) |
| NCT00784134 (46) [back to overview] | Functional Status - Barthel Index |
| NCT00784134 (46) [back to overview] | Functional Status - National Institutes of Health Stroke Scale (NIHSS) |
| NCT00784134 (46) [back to overview] | Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - All Infections |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - All Infections |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - Hospital Days |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - ICP Management |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - ICU Days |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - Pneumonia |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - Pressors |
| NCT00784134 (46) [back to overview] | Intensity of Critical Care Management - Shunts |
| NCT00784134 (46) [back to overview] | Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis |
| NCT00784134 (46) [back to overview] | Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis |
| NCT00784134 (46) [back to overview] | Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis |
| NCT00784134 (46) [back to overview] | Predicting Hazards of Death by Treatment Group |
| NCT00784134 (46) [back to overview] | Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Communication |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Emotion |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Hand Function |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Mobility |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Participation |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Recovery |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Strength |
| NCT00784134 (46) [back to overview] | Quality of Life - Stroke Impact Scale (SIS) - Thinking |
| NCT00784134 (46) [back to overview] | Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 |
| NCT00784134 (46) [back to overview] | Safety/Mortality - Bacterial Brain Infections Within 30 Days |
| NCT00784134 (46) [back to overview] | Safety/Mortality - Mortality Within 30 Days |
| NCT00784134 (46) [back to overview] | Safety/Mortality - Systematic Bleeds Within 30 Days |
| NCT00784134 (46) [back to overview] | Safety/Mortality - Systematic Bleeds Within 72 Hours |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) |
| NCT00784134 (46) [back to overview] | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) |
| NCT00790335 (27) [back to overview] | Severity of Post-thrombotic Syndrome (Villalta) |
| NCT00790335 (27) [back to overview] | Severity of Post-thrombotic Syndrome (Villalta) |
| NCT00790335 (27) [back to overview] | Venous Clinical Severity Score |
| NCT00790335 (27) [back to overview] | Venous Clinical Severity Score |
| NCT00790335 (27) [back to overview] | Venous Clinical Severity Score |
| NCT00790335 (27) [back to overview] | Venous Clinical Severity Score |
| NCT00790335 (27) [back to overview] | Any (Major + Minor) Bleeding |
| NCT00790335 (27) [back to overview] | Any (Minor + Major) Bleeding |
| NCT00790335 (27) [back to overview] | Any Treatment Failure |
| NCT00790335 (27) [back to overview] | Change in General Quality of Life - Mental |
| NCT00790335 (27) [back to overview] | Change in General Quality of Life - Physical |
| NCT00790335 (27) [back to overview] | Change in Leg Circumference |
| NCT00790335 (27) [back to overview] | Change in Leg Circumference |
| NCT00790335 (27) [back to overview] | Change in Leg Pain Severity |
| NCT00790335 (27) [back to overview] | Change in Leg Pain Severity |
| NCT00790335 (27) [back to overview] | Change in Venous Disease-specific Quality of Life |
| NCT00790335 (27) [back to overview] | Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) |
| NCT00790335 (27) [back to overview] | Death |
| NCT00790335 (27) [back to overview] | Death |
| NCT00790335 (27) [back to overview] | Major Bleeding |
| NCT00790335 (27) [back to overview] | Major Bleeding |
| NCT00790335 (27) [back to overview] | Major Non-post-thrombotic Syndrome Treatment Failure |
| NCT00790335 (27) [back to overview] | Moderate-to-severe Post-thrombotic Syndrome |
| NCT00790335 (27) [back to overview] | Recurrent Venous Thromboembolism |
| NCT00790335 (27) [back to overview] | Recurrent Venous Thromboembolism |
| NCT00790335 (27) [back to overview] | Severity of Post-thrombotic Syndrome (Villalta) |
| NCT00790335 (27) [back to overview] | Severity of Post-thrombotic Syndrome (Villalta) |
| NCT01183533 (3) [back to overview] | Mortality |
| NCT01183533 (3) [back to overview] | Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients |
| NCT01183533 (3) [back to overview] | 90-day Modified Rankin Scale (mRS) Score 0 or 1 |
| NCT01197573 (3) [back to overview] | Number of Participants With Primary Liver Graft Nonfunction |
| NCT01197573 (3) [back to overview] | Delayed Kidney Graft Function |
| NCT01197573 (3) [back to overview] | Number of Participants With Liver Ischemic-Type Biliary Strictures |
| NCT01222117 (2) [back to overview] | The Proportion of Subjects With >50% Thrombolysis |
| NCT01222117 (2) [back to overview] | The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability. |
| NCT01282242 (2) [back to overview] | Number of Subjects With Symptomatic Intracerebral Hemorrhage |
| NCT01282242 (2) [back to overview] | Number of Subjects With Symptomatic Cerebral Edema |
| NCT01429350 (4) [back to overview] | Good Clinical Outcome |
| NCT01429350 (4) [back to overview] | Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 |
| NCT01429350 (4) [back to overview] | Incidence of All Serious Adverse Events |
| NCT01429350 (4) [back to overview] | Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage |
| NCT01464788 (2) [back to overview] | Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration |
| NCT01464788 (2) [back to overview] | Number of Participants With 0 or 1 on Modified Rankin Scale |
| NCT01513759 (6) [back to overview] | Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy |
| NCT01513759 (6) [back to overview] | Number of Participants With Major Bleeding |
| NCT01513759 (6) [back to overview] | Number of Participants Who Died Due to Any Cause |
| NCT01513759 (6) [back to overview] | Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE) |
| NCT01513759 (6) [back to overview] | Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy |
| NCT01513759 (6) [back to overview] | Number of Devices That Could Not be Successfully Used for Infusion |
| NCT01643902 (2) [back to overview] | Functional Outcome by the Modified Rankin Scale at 90 Days |
| NCT01643902 (2) [back to overview] | Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment |
| NCT01657461 (10) [back to overview] | Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days |
| NCT01657461 (10) [back to overview] | Death Due to Any Cause at 90 Days |
| NCT01657461 (10) [back to overview] | Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage |
| NCT01657461 (10) [back to overview] | Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization |
| NCT01657461 (10) [back to overview] | Arterial Revascularization Measured by TICI 2b or 3 Following Device Use |
| NCT01657461 (10) [back to overview] | 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). |
| NCT01657461 (10) [back to overview] | Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization |
| NCT01657461 (10) [back to overview] | Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization |
| NCT01657461 (10) [back to overview] | Incidence of sICH at 27±6 Hours Post Randomization |
| NCT01657461 (10) [back to overview] | Incidence of All Serious Adverse Events (SAEs) |
| NCT01717742 (10) [back to overview] | Time to Drain Removal |
| NCT01717742 (10) [back to overview] | Time to Hospital Discharge |
| NCT01717742 (10) [back to overview] | Time to Meeting Discharge Criteria |
| NCT01717742 (10) [back to overview] | Mortality |
| NCT01717742 (10) [back to overview] | Cost of the Hospitalization |
| NCT01717742 (10) [back to overview] | Duration of Fever After Intervention |
| NCT01717742 (10) [back to overview] | Number of Participants With Further Interventions |
| NCT01717742 (10) [back to overview] | Number of Participants With Hospital Readmission |
| NCT01717742 (10) [back to overview] | Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention |
| NCT01717742 (10) [back to overview] | Number of Participants With Serious Bleeding |
| NCT01827046 (18) [back to overview] | Mortality and Safety Events: Summary of AE and SAE by MedDRA Code and Grouped by Organ System Within the First 30 Days Post Ictus |
| NCT01827046 (18) [back to overview] | Patient Disposition: Patient Location at 365 Days Post Ictus (i.e., Good vs. Bad Location) (Adjusted) |
| NCT01827046 (18) [back to overview] | Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 180 Days Post Ictus (Adjusted) |
| NCT01827046 (18) [back to overview] | EuroQol 5 Dimensional Scale (EQ-5D) |
| NCT01827046 (18) [back to overview] | Dichotomized, Adjudicated, Cross-sectional Modified Rankin Scale (mRS) Score 0-3 vs. 4-6 180 Days Post Ictus (Adjusted) |
| NCT01827046 (18) [back to overview] | Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted) |
| NCT01827046 (18) [back to overview] | Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 365 Days Post Ictus (Adjusted) |
| NCT01827046 (18) [back to overview] | Mortality and Safety Events: Adjudicated Bacterial Brain Infection |
| NCT01827046 (18) [back to overview] | EQ-VAS |
| NCT01827046 (18) [back to overview] | All Cause Mortality Longitudinally From Ictus to 365 Days (Adjusted) |
| NCT01827046 (18) [back to overview] | Mortality and Safety Events: Adjudicated Symptomatic Brain Bleeding Within 72 Hours After Last Dose |
| NCT01827046 (18) [back to overview] | Mortality and Safety Events: All Cause Mortality |
| NCT01827046 (18) [back to overview] | Mortality and Safety Events: First-week (Operative) Mortality |
| NCT01827046 (18) [back to overview] | Clot Removal (Amount of Residual Blood) |
| NCT01827046 (18) [back to overview] | Mortality and Safety Events: Total Serious Adverse Events (SAE) at 30 Days |
| NCT01827046 (18) [back to overview] | Patient Disposition: Home Days Over 365 Days Time From Ictus. |
| NCT01827046 (18) [back to overview] | Type and Intensity of ICU Management: Hospital Days |
| NCT01827046 (18) [back to overview] | Type and Intensity of ICU Management: ICU Days |
| NCT01958164 (5) [back to overview] | Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group. |
| NCT01958164 (5) [back to overview] | Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse |
| NCT01958164 (5) [back to overview] | Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0 |
| NCT01958164 (5) [back to overview] | Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse |
| NCT01958164 (5) [back to overview] | Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication |
| NCT02072226 (9) [back to overview] | Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS |
| NCT02072226 (9) [back to overview] | Percentage of Participants With Serious Adverse Events |
| NCT02072226 (9) [back to overview] | Distribution of Participants Across the Ordinal mRS |
| NCT02072226 (9) [back to overview] | Percentage of Participants With Adverse Events |
| NCT02072226 (9) [back to overview] | Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90 |
| NCT02072226 (9) [back to overview] | Percentage of Participants Who Died Due to Stroke and Neurological Disorders |
| NCT02072226 (9) [back to overview] | Overall Mortality |
| NCT02072226 (9) [back to overview] | Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH ) |
| NCT02072226 (9) [back to overview] | Percentage of Participants With Any ICH |
| NCT02159521 (18) [back to overview] | Number of Participants With Major Bleeding |
| NCT02159521 (18) [back to overview] | Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Day 30 |
| NCT02159521 (18) [back to overview] | Time From Starting Initial Thrombolytic Infusion to Discharge From the Hospital |
| NCT02159521 (18) [back to overview] | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Sub-Scale Score and Physical Component Score (PCS) at Days, 30, 90, 180, and 365 |
| NCT02159521 (18) [back to overview] | Change From Baseline in Blood Flow (Calculated by Time to Washout in the Affected Segment) at Post-Adjunctive Therapy |
| NCT02159521 (18) [back to overview] | Change From Baseline in Ouriel Score (Venous Volumetric Index [VVI]) at Post-Adjunctive Therapy |
| NCT02159521 (18) [back to overview] | Number of Treated Limbs With Shift From Baseline in Clinical Stages (Symptomatic and Asymptomatic) of Clinical, Etiologic, Anatomic, Pathophysiological (CEAP) Classification at Days 30, 90, 180, and 365 |
| NCT02159521 (18) [back to overview] | Change From Baseline in Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) Score At Days 30, 90, 180, and 360 |
| NCT02159521 (18) [back to overview] | Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment Procedure |
| NCT02159521 (18) [back to overview] | Change From Baseline in Villalta Score at Days 90, 180, and 365 Post-EkoSonic® Study Treatment Procedure |
| NCT02159521 (18) [back to overview] | Number of Participants Who Had Adverse Events (AEs), Related (to the Study Procedure/Device/Medications) AEs, and Serious Adverse Events (SAEs) |
| NCT02159521 (18) [back to overview] | Number of Participants With PTS-induced Admission to an Emergency Room or Unplanned Visits to a Physician's Office or Hospitalization |
| NCT02159521 (18) [back to overview] | Percentage of Treated Veins Segments of Limbs With Absence of Re-Occlusion, as Documented by Duplex Imaging |
| NCT02159521 (18) [back to overview] | Number of Participants Who Died Due to Any Cause |
| NCT02159521 (18) [back to overview] | Number of Participants Who Had Symptomatic PE During Hospitalization for Study Procedure |
| NCT02159521 (18) [back to overview] | Number of Participants With at Least 5-Point Reduction From Baseline in Ouriel Score at Post-Adjunctive Therapy |
| NCT02159521 (18) [back to overview] | Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Days 90, 180, and 365 |
| NCT02159521 (18) [back to overview] | Change From Baseline in Venous Clinical Severity Score (VCSS) in Study Leg at Days 30, 90, 180, and 365 |
| NCT02315898 (10) [back to overview] | Detection of Fibrin Degradation Product (FDP) in the Systemic Circulation |
| NCT02315898 (10) [back to overview] | Forced Expiratory Flow 25-75% (FEF25-75) |
| NCT02315898 (10) [back to overview] | Forced Expiratory Volume in One Second (FEV1) |
| NCT02315898 (10) [back to overview] | Forced Vital Capacity (FVC) |
| NCT02315898 (10) [back to overview] | Requirement for Urgent or Emergent Bronchoscopy |
| NCT02315898 (10) [back to overview] | Frequency of Production/Expectoration of Airway Casts |
| NCT02315898 (10) [back to overview] | Primary Endpoint: Number of Subjects That Develop New, Active Bleeding |
| NCT02315898 (10) [back to overview] | Requirement for Mechanical Ventilation |
| NCT02315898 (10) [back to overview] | Arterial Oxygen Saturation (%) |
| NCT02315898 (10) [back to overview] | Changes in the Chest X-ray (CXR) |
| NCT02396758 (28) [back to overview] | Change in Borg Scale Score Before and After 6MW Distance Test at Days 30, 90, and 365 |
| NCT02396758 (28) [back to overview] | Percentage of Participants With Collapse of the Inferior Vena Cava (IVC) With Respiration at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph |
| NCT02396758 (28) [back to overview] | For Participants of UK Sites: Time From Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for PE |
| NCT02396758 (28) [back to overview] | Healthcare Resource Utilization: Number of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only) |
| NCT02396758 (28) [back to overview] | Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12month Follow-up. (UK Participants Only) |
| NCT02396758 (28) [back to overview] | Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12 Month Follow-up. (UK Participants Only) |
| NCT02396758 (28) [back to overview] | Healthcare Resource Utilization: Duration of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only) |
| NCT02396758 (28) [back to overview] | For Participants of UK Sites: Time From Hospital Admission to Diagnosis of PE |
| NCT02396758 (28) [back to overview] | For Participants of UK Sites: Freedom From Major Harm Occurring Between Enrolment and 30 Days |
| NCT02396758 (28) [back to overview] | Change From Baseline in RV/LV at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph. |
| NCT02396758 (28) [back to overview] | Number of Participants With Major Bleeding Within 72 Hours After Initiating the APT Procedure |
| NCT02396758 (28) [back to overview] | For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge |
| NCT02396758 (28) [back to overview] | For Participants of UK Sites:Change in EuroQual - 5 Dimensions - 5 Levels (EQ-5D-5L) Score From Day 30 to Day 365 |
| NCT02396758 (28) [back to overview] | Number of Participants Who Received Oxygen Therapy |
| NCT02396758 (28) [back to overview] | Change in 6 Minute Walk (6MW) Distance From Day 30 to Day 90 and 365 |
| NCT02396758 (28) [back to overview] | Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph |
| NCT02396758 (28) [back to overview] | Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Score From Day 30 to Day 365 |
| NCT02396758 (28) [back to overview] | Change in Participant Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) 6b Score From Day 30 to Day 365 |
| NCT02396758 (28) [back to overview] | Change From Baseline in Thrombus Burden by Modified Miller Score as Assessed by CTA Scan at 48 ± 6 Hours After the Start of the APT Procedure |
| NCT02396758 (28) [back to overview] | Change From Baseline in Thrombus Burden by Miller Score as Assessed by Pulmonary Arteriogram (PAgram) at Day 0 |
| NCT02396758 (28) [back to overview] | Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio to 48 ± 6 Hours After the Start of the APT Procedure |
| NCT02396758 (28) [back to overview] | Change From Baseline in Estimated Right Ventricular Systolic Pressure (RVSP) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph |
| NCT02396758 (28) [back to overview] | Percentage of Participants With Treatment Success of an APT Procedure |
| NCT02396758 (28) [back to overview] | Number of Participants With Symptomatic Recurrent Pulmonary Embolism (Per Adjudication) |
| NCT02396758 (28) [back to overview] | Number of Participants Who Encountered Technical Procedural Complications |
| NCT02396758 (28) [back to overview] | Number of Participants Who Die Due to Any Cause |
| NCT02396758 (28) [back to overview] | Healthcare Resource Utilization: Team Managing the Participant During Hospitalization - Number of Healthcare Professional (HCP) Specialties Involved. (UK Participants Only) |
| NCT02396758 (28) [back to overview] | For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge |
| NCT02752256 (2) [back to overview] | Average Time to rtPA |
| NCT02752256 (2) [back to overview] | Percentage of Participants With a rtPA Protocol Violation |
| NCT02930837 (7) [back to overview] | The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema |
| NCT02930837 (7) [back to overview] | The Percentage of Patients With Severity of Adverse Events |
| NCT02930837 (7) [back to overview] | Patient Survival Probability at Visit 5 (Censoring at Day 90) |
| NCT02930837 (7) [back to overview] | The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1 |
| NCT02930837 (7) [back to overview] | The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period |
| NCT02930837 (7) [back to overview] | The Percentage of Patients With Death Related to Stroke or of Neurological Causes |
| NCT02930837 (7) [back to overview] | The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient |
| NCT03468933 (5) [back to overview] | Duration of Hospital Stay After Intervention |
| NCT03468933 (5) [back to overview] | Number of Participants Necessitating Intervention After the Assigned Treatment |
| NCT03468933 (5) [back to overview] | Total Length of Hospital Stay |
| NCT03468933 (5) [back to overview] | In Hospital and 30-day Mortality |
| NCT03468933 (5) [back to overview] | Adverse Events |
| NCT03672006 (5) [back to overview] | Episodes of CVC Dysfunction |
| NCT03672006 (5) [back to overview] | Clinical Bleeding |
| NCT03672006 (5) [back to overview] | Catheter-associated Bloodstream Infection |
| NCT03672006 (5) [back to overview] | Off Study Use of t-PA |
| NCT03672006 (5) [back to overview] | Catheter-associated Venous Thrombosis |
| NCT04357730 (22) [back to overview] | PaO2/FiO2 Ratio at 24 Hours |
| NCT04357730 (22) [back to overview] | PaO2/FiO2 Change (Increase) From Pre-to-post Intervention |
| NCT04357730 (22) [back to overview] | PaO2/FiO2 at 48 Hours |
| NCT04357730 (22) [back to overview] | PaO2/FiO2 at 24 Hours |
| NCT04357730 (22) [back to overview] | Number of Patients Who Required Paralytics 48 Hours Post-randomization |
| NCT04357730 (22) [back to overview] | Number of Participants With Adverse Events |
| NCT04357730 (22) [back to overview] | National Early Warning Score 2 (NEWS2) |
| NCT04357730 (22) [back to overview] | INR at 24 Hours |
| NCT04357730 (22) [back to overview] | aPTT at 48 Hours |
| NCT04357730 (22) [back to overview] | D-dimer at 48 Hours |
| NCT04357730 (22) [back to overview] | Intensive Care Unit (ICU) Days |
| NCT04357730 (22) [back to overview] | Fibrinogen at 24 Hours |
| NCT04357730 (22) [back to overview] | INR at 48 Hours |
| NCT04357730 (22) [back to overview] | 28 Days In-hospital Mortality |
| NCT04357730 (22) [back to overview] | Ventilation Days |
| NCT04357730 (22) [back to overview] | Fibrinogen at 48 Hours |
| NCT04357730 (22) [back to overview] | Achievement of PaO2/FiO2 ≥ 200 or 50% Increase in PaO2/FiO2 |
| NCT04357730 (22) [back to overview] | aPTT at 24 Hours |
| NCT04357730 (22) [back to overview] | Number of Participants With Bleeding Events |
| NCT04357730 (22) [back to overview] | D-dimer at 24 Hours |
| NCT04357730 (22) [back to overview] | ICU-free Days |
| NCT04357730 (22) [back to overview] | Ventilator-free Days |
| NCT04419493 (3) [back to overview] | Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax) |
| NCT04419493 (3) [back to overview] | Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞) |
| NCT04419493 (3) [back to overview] | Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz) |
All-Cause Mortality Through 1 Year
All-cause mortality through 1 year from randomization. (NCT00046228)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 56 |
| Abciximab Facilitated PCI Group | 60 |
| Reteplase/Abciximab Facilitated PCI Group | 52 |
All-Cause Mortality Through 90 Days
All cause mortality occurred through 90 days from randomization. (NCT00046228)
Timeframe: 90 days
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 36 |
| Abciximab Facilitated PCI Group | 45 |
| Reteplase/Abciximab Facilitated PCI Group | 43 |
Complications of MI as Defined in the Primary Outcome Measure Through 90 Days
The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization. (NCT00046228)
Timeframe: 90 Days
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 72 |
| Abciximab Facilitated PCI Group | 61 |
| Reteplase/Abciximab Facilitated PCI Group | 61 |
Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7
(NCT00046228)
Timeframe: Discharge/Day 7
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 139 |
| Abciximab Facilitated PCI Group | 178 |
| Reteplase/Abciximab Facilitated PCI Group | 271 |
The Composite of All-Cause Mortality or Complications of MI at 90 Days.
Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization). (NCT00046228)
Timeframe: 90 days
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 86 |
| Abciximab Facilitated PCI Group | 86 |
| Reteplase/Abciximab Facilitated PCI Group | 81 |
Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization
(NCT00046228)
Timeframe: 60 to 90 minutes
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 75 |
| Abciximab Facilitated PCI Group | 85 |
| Reteplase/Abciximab Facilitated PCI Group | 108 |
Subjects With Severe Thrombocytopenia Through Discharge/Day 7
Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL. (NCT00046228)
Timeframe: Discharge/Day 7
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 11 |
| Abciximab Facilitated PCI Group | 16 |
| Reteplase/Abciximab Facilitated PCI Group | 16 |
Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7
Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion. (NCT00046228)
Timeframe: Discharge/Day 7
| Intervention | participants (Number) |
|---|
| Primary PCI Group | 128 |
| Abciximab Facilitated PCI Group | 122 |
| Reteplase/Abciximab Facilitated PCI Group | 120 |
Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7
Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined. (NCT00046228)
Timeframe: Discharge/Day 7
| Intervention | participant (Number) |
|---|
| Primary PCI Group | 55 |
| Abciximab Facilitated PCI Group | 81 |
| Reteplase/Abciximab Facilitated PCI Group | 118 |
Number of Participants With Restored Venous Function
The outcome measures the ability of Alteplase to lyse acute and subacute deep venous thrombosis (DVT) of the lower extremities and/or pelvis and restore venous function, or blood flow, to these areas. Restored venous function is also known as patency. Patency is measured by venography and ultrasound exams. (NCT00082355)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Alteplase | 28 |
Number of Participants That Developed Hemorrhage
The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT. (NCT00082355)
Timeframe: 5 days
| Intervention | participants (Number) |
|---|
| Alteplase | 0 |
Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
The number of patients with sICH (NCT00147316)
Timeframe: within 36 hours
| Intervention | participants (Number) |
|---|
| Alteplase | 6 |
Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months
The number of patients with a mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability. (NCT00147316)
Timeframe: at 3 months
| Intervention | participants (Number) |
|---|
| Alteplase | 38 |
Mortality at 30 Days
(NCT00178620)
Timeframe: 30 day
| Intervention | participants (Number) |
|---|
| Group A | 1 |
| Group B | 7 |
| Group C | 3 |
| Group D | 2 |
Ordinal Modified Rankin Scale (mRS) at Day 180
Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures 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 ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. (NCT00224770)
Timeframe: 180 days from randomization
| Intervention | units on a scale (Median) |
|---|
| Medical Management | 4 |
| MISTIE Surgical Management | 4 |
| ICES Surgical Management | 4 |
Ordinal Modified Rankin Scale (mRS) at Day 365
Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures 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 ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. (NCT00224770)
Timeframe: 365 days from randomization
| Intervention | units on a scale (Median) |
|---|
| Medical Management | 4.5 |
| MISTIE Surgical Management | 4 |
| ICES Surgical Management | 3.5 |
Post-operative Clot Size Reduction
The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients. (NCT00224770)
Timeframe: Time from post-operation until end of treatment, up to 10 days
| Intervention | percentage of blood clot resolved (Median) |
|---|
| MISTIE Surgical Management | 56.7 |
| ICES Surgical Management | -6.4 |
Safety Outcome Number 1: Rate of Mortality
Percentage of participants who died during the first 30 days after randomization. (NCT00224770)
Timeframe: 30 days from randomization
| Intervention | percentage of participants (Number) |
|---|
| Medical Management | 9.5 |
| MISTIE Surgical Management | 14.8 |
| ICES Surgical Management | 7.1 |
Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180
Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures 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 ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead (NCT00224770)
Timeframe: 180 days from randomization
| Intervention | percentage of participants (Number) |
|---|
| Medical Management | 23.7 |
| MISTIE Surgical Management | 34.6 |
| ICES Surgical Management | 42.9 |
Safety Outcome Number 4: Rate of Symptomatic Rebleeding
The difference in the rate of symptomatic rebleeding 72 hours post last dose. (NCT00224770)
Timeframe: 72 hours post last dose
| Intervention | percentage of participants (Number) |
|---|
| Medical Management | 2.4 |
| MISTIE Surgical Management | 5.6 |
| ICES Surgical Management | 0 |
Clot Size Reduction by End of Treatment
The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan. (NCT00224770)
Timeframe: Time from randomization until end of treatment, up to 10 days
| Intervention | percentage of blood clot resolved (Median) |
|---|
| Medical Management | 3.9 |
| MISTIE Surgical Management | 64.3 |
| ICES Surgical Management | 69.5 |
Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization. (NCT00224770)
Timeframe: 30 days from randomization
| Intervention | percentage of participants (Number) |
|---|
| Medical Management | 2.4 |
| MISTIE Surgical Management | 0 |
| ICES Surgical Management | 0 |
Functional Handicap (Modified Rankin Score)
The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported. (NCT00252239)
Timeframe: 3 months
| Intervention | percentage of participants (Number) |
|---|
| TNK 0.1 mg/kg | 22.6 |
| TNK 0.25 mg/kg | 35.5 |
| TNK 0.4 mg/kg | 31.6 |
| tPA 0.9 mg/kg | 32.3 |
Duration (in Days) of Percutaneous Drainage.
The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days. (NCT00284739)
Timeframe: Up to 30 days
| Intervention | days (Mean) |
|---|
| Alteplase | 6 |
| Saline | 11 |
Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage
(NCT00284739)
Timeframe: 30 days
| Intervention | participants (Number) |
|---|
| Alteplase | 3 |
| Saline | 7 |
Incidence of Parenchymal Type II (PH2) Hematomas
a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans. (NCT00359424)
Timeframe: within 30 hours post IV rt-PA
| Intervention | participants (Number) |
|---|
| Endovascular Therapy | 25 |
| IV Rt-PA Alone | 13 |
Symptomatic Intracranial Hemorrhage
Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site (NCT00359424)
Timeframe: within the first 30 hours post IV rt-PA
| Intervention | participants (Number) |
|---|
| Endovascular Therapy | 27 |
| IV Rt-PA Alone | 13 |
Trail Making Test Part A Time
"The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a trail made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes." (NCT00359424)
Timeframe: 90 days post randomization
| Intervention | seconds (Mean) |
|---|
| Endovascular Therapy | 84.2 |
| IV Rt-PA Alone | 82.0 |
Trail Making Test Part B Time
"The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a trail made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes." (NCT00359424)
Timeframe: at 90 days post randomization
| Intervention | seconds (Mean) |
|---|
| Endovascular Therapy | 143.8 |
| IV Rt-PA Alone | 141.3 |
Barthel Index (BI) Dichotomized 0-90 Versus 95-100
The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence. (NCT00359424)
Timeframe: at 90 days post randomization
| Intervention | participants (Number) |
|---|
| BI 95-100 | BI 0-90 |
|---|
| Endovascular Therapy | 183 | 251 |
,| IV Rt-PA Alone | 86 | 136 |
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. (NCT00359424)
Timeframe: 270 days
| Intervention | participants (Number) |
|---|
| mRS 0-2 | mRS 3-6 |
|---|
| Endovascular Therapy | 177 | 257 |
,| IV Rt-PA Alone | 88 | 134 |
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. (NCT00359424)
Timeframe: 360 days post randomization
| Intervention | participants (Number) |
|---|
| mRS 0-2 | mRS 3-6 |
|---|
| Endovascular Therapy | 191 | 243 |
,| IV Rt-PA Alone | 95 | 127 |
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. (NCT00359424)
Timeframe: at 180 days
| Intervention | participants (Number) |
|---|
| mRS 0-2 | mRS 3-6 |
|---|
| Endovascular Therapy | 179 | 255 |
,| IV Rt-PA Alone | 86 | 136 |
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.
The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. (NCT00359424)
Timeframe: at 90 days post randomization
| Intervention | participants (Number) |
|---|
| mRS 0-2 | mRS 3-6 |
|---|
| Endovascular Therapy | 177 | 257 |
,| IV Rt-PA Alone | 86 | 136 |
National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.
"The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher~>> scores indicating greater severity of deficit." (NCT00359424)
Timeframe: at 24 hours post randomization
| Intervention | participants (Number) |
|---|
| NIHSS 0-1 | NIHSS 2+ |
|---|
| Endovascular Therapy | 44 | 390 |
,| IV Rt-PA Alone | 22 | 200 |
National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.
The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit. (NCT00359424)
Timeframe: at 90 days post randomization
| Intervention | participants (Number) |
|---|
| NIHSSS 0-1 | NIHSSS 2+ |
|---|
| Endovascular Therapy | 120 | 314 |
,| IV Rt-PA Alone | 50 | 172 |
Asymptomatic Intracranial Hemorrhage
Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site. (NCT00359424)
Timeframe: within 30 hours post IV rt-PA
| Intervention | participants (Number) |
|---|
| Endovascular Therapy | 119 |
| IV Rt-PA Alone | 42 |
Death Due to Any Cause
(NCT00359424)
Timeframe: within 90 days post randomization
| Intervention | participants (Number) |
|---|
| Endovascular Therapy | 83 |
| IV Rt-PA Alone | 48 |
Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)
"Recanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in <50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory.~The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization." (NCT00412867)
Timeframe: within 6 hours, from 24 to 36 hours after onset
| Intervention | participants (Number) |
|---|
| within 6 hours after onset | from 24 to 36 hours after onset |
|---|
| Alteplase | 30 | 40 |
National Institutes of Health Stroke Scale (NIHSS) Score
from 0 (normal) to 40 (most severe) (NCT00412867)
Timeframe: within 6 hours, from 24 to 36 hours, 3 months after onset.
| Intervention | units on a scale (Median) |
|---|
| within 6 hours | from 24 to 36 hours | 3 months after onset |
|---|
| Alteplase | 8.5 | 7.0 | 1.5 |
Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
The number of patients with sICH (NCT00412867)
Timeframe: within 36 hours after starting treatment
| Intervention | participants (Number) |
|---|
| Alteplase | 0 |
Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months
The number of patients with an mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability. (NCT00412867)
Timeframe: 3 months after onset
| Intervention | participants (Number) |
|---|
| Alteplase | 27 |
Barthel Index (BI)
from 100 (Independent) to 0 (full assistance) (NCT00412867)
Timeframe: the day of discharge within 3 months after onset, and 3 months after onset
| Intervention | units on a scale (Mean) |
|---|
| the day of discharge within 3 months after onset | 3 months after onset |
|---|
| Alteplase | 76.2 | 77.8 |
Percentage of Participants With Adverse Events and Adverse Drug Reactions
(NCT00412867)
Timeframe: 3 months
| Intervention | percentage of patients (Number) |
|---|
| Percentage of Patients with Adverse Events | Percentage of Patients with Adverse Drug Reactions |
|---|
| Alteplase | 96.6 | 41.4 |
No Surgical Intervention
CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery. (NCT00468104)
Timeframe: patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months
| Intervention | participants (Number) |
|---|
| Alteplase | 66 |
| Placebo | 6 |
Rate of Symptomatic Bleeding Events
The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review. (NCT00650858)
Timeframe: 30-days
| Intervention | participants (Number) |
|---|
| 0.3 mg Rt-PA q12h | 0 |
| 1.0 mg Rt-PA q12h | 0 |
| 1.0 mg Rt-PA q8h | 2 |
30-day Mortality
The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review. (NCT00650858)
Timeframe: 30 days
| Intervention | Number of participants (Number) |
|---|
| 0.3 mg Rt-PA q12h | 1 |
| 1.0 mg Rt-PA q12h | 1 |
| 1.0 mg Rt-PA q8h | 6 |
Average Daily Percentage Clot Size Resolution Over the First 3 Days
Daily IVH clot volume resolution, as a percentage of stability CT IVH volume, averaged over the first 3 days, determined by CT scans (NCT00650858)
Timeframe: 3 days
| Intervention | Percent of stability CT volume resolved (Mean) |
|---|
| 0.3 mg Rt-PA q12h | 22.19 |
| 1.0 mg Rt-PA q12h | 24.20 |
| 1.0 mg Rt-PA q8h | 19.99 |
Incidence of Bacterial Ventriculitis, Meningitis
The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review. (NCT00650858)
Timeframe: 30 days
| Intervention | Number of participants (Number) |
|---|
| 0.3 mg Rt-PA q12h | 0 |
| 1.0 mg Rt-PA q12h | 1 |
| 1.0 mg Rt-PA q8h | 1 |
90 Day Follow-Up Glasgow Outcome Scale (GOS) Score
"90 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)" (NCT00650858)
Timeframe: 90 days
| Intervention | GOS score (Median) |
|---|
| 1.0 mg Rt-PA q8h | 2.3 |
180 Day Follow-Up Glasgow Outcome Scale (GOS) Score
"180 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)" (NCT00650858)
Timeframe: 180 days
| Intervention | GOS score (Median) |
|---|
| 1.0 mg Rt-PA q8h | 2.3 |
180 Day Follow-Up Modified Rankin Scale (mRS) Score
"180 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used 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. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)" (NCT00650858)
Timeframe: 180 days
| Intervention | mRS score (Median) |
|---|
| 1.0 mg Rt-PA q8h | 4.0 |
90 Day Follow-Up Modified Rankin Scale (mRS) Score
"90 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used 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. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.~(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)" (NCT00650858)
Timeframe: 90 days
| Intervention | mRS score (Median) |
|---|
| 1.0 mg Rt-PA q8h | 4.3 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 18.5 |
| Saline Placebo | 17.9 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 55.1 |
| Saline Placebo | 58.3 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 60.6 |
| Saline Placebo | 54.7 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 38.8 |
| Saline Placebo | 37.4 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 47.6 |
| Saline Placebo | 44.3 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 43.4 |
| Saline Placebo | 41.8 |
Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3
Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 30 days and 180 days
| Intervention | Percentage of participants (Number) |
|---|
| Day 30 | Day 180 |
|---|
| Alteplase | 20.4 | 48.0 |
,| Saline Placebo | 16.5 | 45.7 |
Intensity of Critical Care Management - Mechanical Ventilation
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | % of participants with ventilation (Number) |
|---|
| Alteplase | 73.9 |
| Saline Placebo | 76.5 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)
Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | Percentage of participants (Number) |
|---|
| Alteplase | 54.4 |
| Saline Placebo | 48.0 |
Adverse and Serious Adverse Events
Assessment of number of adverse and serious adverse events by treatment group. (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 45.8 |
| Saline Placebo | 60.2 |
All Cause Mortality
(NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 18.5 |
| Saline Placebo | 29.1 |
Clot Removal (Amount of Residual Blood)
Change in blood volume measured between stability scan and end of treatment scan (NCT00784134)
Timeframe: 72 hours
| Intervention | odds ratio per time-weighted ml (Number) |
|---|
| Alteplase | 0.96 |
| Saline Placebo | 0.97 |
Functional Status - Barthel Index
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence. (NCT00784134)
Timeframe: 180 days
| Intervention | Barthel score (Mean) |
|---|
| Alteplase | 65.2 |
| Saline Placebo | 69.5 |
Functional Status - National Institutes of Health Stroke Scale (NIHSS)
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke). (NCT00784134)
Timeframe: 180 days
| Intervention | NIHSS score (Median) |
|---|
| Alteplase | 3 |
| Saline Placebo | 2 |
Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability
Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery. (NCT00784134)
Timeframe: 180 days
| Intervention | % of participants with score>=4 (Number) |
|---|
| Alteplase | 95 |
| Saline Placebo | 77 |
Intensity of Critical Care Management - All Infections
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 180 days
| Intervention | % of participants with infections (Number) |
|---|
| Alteplase | 49.8 |
| Saline Placebo | 56.2 |
Intensity of Critical Care Management - All Infections
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | % of participants with infections (Number) |
|---|
| Alteplase | 48.2 |
| Saline Placebo | 50.6 |
Intensity of Critical Care Management - Hospital Days
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | Number of days (Median) |
|---|
| Alteplase | 23 |
| Saline Placebo | 24 |
Intensity of Critical Care Management - ICP Management
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | Percentage of events of ICP >20mmHg (Number) |
|---|
| Alteplase | 9.8 |
| Saline Placebo | 10.2 |
Intensity of Critical Care Management - ICU Days
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | Number of days (Median) |
|---|
| Alteplase | 14 |
| Saline Placebo | 15 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 47.3 |
| Saline Placebo | 38.5 |
Intensity of Critical Care Management - Pneumonia
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | % of participants with pneumonia (Number) |
|---|
| Alteplase | 26.1 |
| Saline Placebo | 32.7 |
Intensity of Critical Care Management - Pressors
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | % of participants with pressors (Number) |
|---|
| Alteplase | 24.1 |
| Saline Placebo | 25.1 |
Intensity of Critical Care Management - Shunts
Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. (NCT00784134)
Timeframe: 30 days
| Intervention | % of participants with shunts (Number) |
|---|
| Alteplase | 18.5 |
| Saline Placebo | 17.5 |
Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis
The modified Rankin Scale (mRS) is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | mRS score (Median) |
|---|
| Alteplase | 4 |
| Saline Placebo | 4 |
Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis
Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 47.6 |
| Saline Placebo | 44.9 |
Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis
The modified Rankin Scale (mRS) is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 64.2 |
| Saline Placebo | 61.6 |
Predicting Hazards of Death by Treatment Group
Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group. (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 18.5 |
| Saline Placebo | 29.1 |
Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)
Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine). (NCT00784134)
Timeframe: 180 days
| Intervention | EuroQol score (Mean) |
|---|
| Alteplase | 62.8 |
| Saline Placebo | 65.1 |
Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 59.33 |
| Saline Placebo | 61.19 |
Quality of Life - Stroke Impact Scale (SIS) - Communication
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 76.02 |
| Saline Placebo | 79.60 |
Quality of Life - Stroke Impact Scale (SIS) - Emotion
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 73.14 |
| Saline Placebo | 73.45 |
Quality of Life - Stroke Impact Scale (SIS) - Hand Function
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 53.41 |
| Saline Placebo | 56.52 |
Quality of Life - Stroke Impact Scale (SIS) - Mobility
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 58.30 |
| Saline Placebo | 60.10 |
Quality of Life - Stroke Impact Scale (SIS) - Participation
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 47.46 |
| Saline Placebo | 49.58 |
Quality of Life - Stroke Impact Scale (SIS) - Recovery
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 60.04 |
| Saline Placebo | 63.44 |
Quality of Life - Stroke Impact Scale (SIS) - Strength
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 54.97 |
| Saline Placebo | 58.75 |
Quality of Life - Stroke Impact Scale (SIS) - Thinking
Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. (NCT00784134)
Timeframe: 180 days
| Intervention | SIS score (Mean) |
|---|
| Alteplase | 58.48 |
| Saline Placebo | 62.68 |
Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3
The modified Rankin Scale (mRS) is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 47.6 |
| Saline Placebo | 44.9 |
Safety/Mortality - Bacterial Brain Infections Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. (NCT00784134)
Timeframe: 30 days
| Intervention | % of participants with brain infection (Number) |
|---|
| Alteplase | 6.8 |
| Saline Placebo | 10.4 |
Safety/Mortality - Mortality Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. (NCT00784134)
Timeframe: 30 days
| Intervention | Percentage of patients (Number) |
|---|
| Alteplase | 8.8 |
| Saline Placebo | 14.3 |
Safety/Mortality - Systematic Bleeds Within 30 Days
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. (NCT00784134)
Timeframe: 30 days
| Intervention | % of participants with systematic bleeds (Number) |
|---|
| Alteplase | 3.6 |
| Saline Placebo | 3.2 |
Safety/Mortality - Systematic Bleeds Within 72 Hours
Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. (NCT00784134)
Timeframe: 72 hours
| Intervention | % of participants with systematic bleeds (Number) |
|---|
| Alteplase | 2.4 |
| Saline Placebo | 2.0 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | Percentage of participants (Number) |
|---|
| Alteplase | 53.6 |
| Saline Placebo | 52.1 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | Percentage of participants (Number) |
|---|
| Alteplase | 31.3 |
| Saline Placebo | 29.5 |
Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)
Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used 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. It is scored from 0 (perfect health without symptoms) to 6 (death). (NCT00784134)
Timeframe: 180 days
| Intervention | percentage of participants (Number) |
|---|
| Alteplase | 47.6 |
| Saline Placebo | 45.6 |
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse. (NCT00790335)
Timeframe: At 12 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 3.22 |
| B-Control | 4.38 |
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse. (NCT00790335)
Timeframe: At 6 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 3.11 |
| B-Control | 4.33 |
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item) (NCT00790335)
Timeframe: At 12 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 1.80 |
| B-Control | 2.37 |
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item) (NCT00790335)
Timeframe: At 18 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 1.74 |
| B-Control | 2.80 |
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item) (NCT00790335)
Timeframe: At 24 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 1.87 |
| B-Control | 2.42 |
Venous Clinical Severity Score
Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse (NCT00790335)
Timeframe: At 6 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 1.73 |
| B-Control | 2.68 |
Any (Major + Minor) Bleeding
Clinically overt bleeding that occurred within 24 months post-randomization (NCT00790335)
Timeframe: Within 24 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 46 |
| B-Control | 38 |
Any (Minor + Major) Bleeding
Clinically overt bleeding that occurred through 10 days post-randomization (NCT00790335)
Timeframe: Within 10 days after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 15 |
| B-Control | 6 |
Any Treatment Failure
Composite of PTS and major non-PTS treatment failure (NCT00790335)
Timeframe: Through 24 months
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 158 |
| B-Control | 176 |
Change in General Quality of Life - Mental
Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life. (NCT00790335)
Timeframe: Baseline to 24 months post-randomization
| Intervention | units on a scale (Mean) |
|---|
| A-Intervention | 2.70 |
| B-Control | 2.70 |
Change in General Quality of Life - Physical
Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life. (NCT00790335)
Timeframe: Baseline to 24 months post-randomization
| Intervention | units on a scale (Mean) |
|---|
| A-Intervention | 11.18 |
| B-Control | 10.06 |
Change in Leg Circumference
Mean calf circumference measured 10 cm below the tibial tuberosity (NCT00790335)
Timeframe: Baseline to 10 days post-randomization
| Intervention | centimeters (Mean) |
|---|
| A-Intervention | -0.26 |
| B-Control | 0.27 |
Change in Leg Circumference
Mean calf circumference measured 10 cm below the tibial tuberosity (NCT00790335)
Timeframe: Baseline to 30 days post-randomization
| Intervention | centimeters (Mean) |
|---|
| A-Intervention | -0.74 |
| B-Control | -0.28 |
Change in Leg Pain Severity
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain (NCT00790335)
Timeframe: Baseline to 10 days post-randomization
| Intervention | points (Mean) |
|---|
| A-Intervention | -1.62 |
| B-Control | -1.29 |
Change in Leg Pain Severity
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain (NCT00790335)
Timeframe: Baseline to 30 days post-randomization
| Intervention | points (Mean) |
|---|
| A-Intervention | -2.17 |
| B-Control | -1.83 |
Change in Venous Disease-specific Quality of Life
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline. (NCT00790335)
Timeframe: Baseline to 24 months post-randomization
| Intervention | units on a scale (Mean) |
|---|
| A-Intervention | 27.67 |
| B-Control | 23.47 |
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse. (NCT00790335)
Timeframe: Between 6 and 24 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 157 |
| B-Control | 171 |
Death
All-cause mortality (NCT00790335)
Timeframe: Within 10 days after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 0 |
| B-Control | 0 |
Death
All-cause mortality (NCT00790335)
Timeframe: Within 24 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 7 |
| B-Control | 8 |
Major Bleeding
Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal). (NCT00790335)
Timeframe: Within 10 days after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 6 |
| B-Control | 1 |
Major Bleeding
Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal). (NCT00790335)
Timeframe: Within 24 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 19 |
| B-Control | 13 |
Major Non-post-thrombotic Syndrome Treatment Failure
A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months. (NCT00790335)
Timeframe: Through 24 months
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 4 |
| B-Control | 7 |
Moderate-to-severe Post-thrombotic Syndrome
Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse. (NCT00790335)
Timeframe: Between 6 and 24 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 60 |
| B-Control | 84 |
Recurrent Venous Thromboembolism
Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE) (NCT00790335)
Timeframe: Within 10 days after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 6 |
| B-Control | 4 |
Recurrent Venous Thromboembolism
Symptomatic recurrent venous thromboembolism (DVT and/or PE) (NCT00790335)
Timeframe: Within 24 months after randomization
| Intervention | Participants (Count of Participants) |
|---|
| A-Intervention | 42 |
| B-Control | 30 |
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse. (NCT00790335)
Timeframe: At 18 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 3.32 |
| B-Control | 4.44 |
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse. (NCT00790335)
Timeframe: At 24 months
| Intervention | points (Mean) |
|---|
| A-Intervention | 3.43 |
| B-Control | 4.50 |
Mortality
(NCT01183533)
Timeframe: 90 days
| Intervention | participants (Number) |
|---|
| Off Label Rt-PA | 2 |
90-day Modified Rankin Scale (mRS) Score 0 or 1
Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention. (NCT01183533)
Timeframe: 90 days
| Intervention | participants (Number) |
|---|
| Off Label Rt-PA | 20 |
Number of Participants With Primary Liver Graft Nonfunction
(NCT01197573)
Timeframe: 1 month
| Intervention | Participants (Count of Participants) |
|---|
| Standard DCD Liver Transplant | 2 |
| rTPA Treatment | 1 |
Delayed Kidney Graft Function
(NCT01197573)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|
| rTPA Treatment - Kidney | 5 |
| Standard DCD Kidney Transplant | 7 |
Number of Participants With Liver Ischemic-Type Biliary Strictures
(NCT01197573)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Standard DCD Liver Transplant | 0 |
| rTPA Treatment | 3 |
The Proportion of Subjects With >50% Thrombolysis
The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography. (NCT01222117)
Timeframe: 5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)
| Intervention | percentage of participants (Number) |
|---|
| Plasmin Open-label Treatment Group A | 43.8 |
| Plasmin Open-label Treatment Group B | 47.4 |
| Plasmin Open-label Treatment Group C | 81.0 |
| Plasmin Open-label Treatment Group D | 47.4 |
| Plasminogen Activator Blinded Group E | 88.9 |
| PA Placebo Blinded Treatment Arm F | 40.0 |
| Plasmin Open-label Treatment Group G | 66.7 |
| Plasmin Open-label Treatment Group H | 66.7 |
| Plasmin Open-label Treatment Group I | 73.3 |
| Plasmin Open-label Treatment Group J | 42.9 |
| Plasmin Open-label Treatment Group M | 33.3 |
The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.
The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability. (NCT01222117)
Timeframe: 30 days
| Intervention | percentage of participants (Number) |
|---|
| Adverse events | Serious adverse events | Major bleeding events | Minor bleeding events | Deaths | Abnormal laboratory values |
|---|
| PA Placebo Blinded Treatment Arm F | 88.9 | 55.6 | 11.1 | 33.3 | 11.1 | 22.2 |
,| Plasmin Open-label Treatment Group A | 80.0 | 50.0 | 15.0 | 5.0 | 5.0 | 15.0 |
,| Plasmin Open-label Treatment Group B | 60.0 | 20.0 | 5.0 | 20.0 | 0 | 10.0 |
,| Plasmin Open-label Treatment Group C | 81.8 | 27.3 | 4.5 | 9.1 | 0 | 13.7 |
,| Plasmin Open-label Treatment Group D | 70.0 | 20.0 | 0 | 20.0 | 0 | 0 |
,| Plasmin Open-label Treatment Group G | 69.2 | 30.8 | 0 | 46.2 | 0 | 15.4 |
,| Plasmin Open-label Treatment Group H | 58.3 | 25.0 | 0 | 8.3 | 0 | 0 |
,| Plasmin Open-label Treatment Group I | 66.7 | 33.3 | 9.5 | 28.6 | 0 | 4.8 |
,| Plasmin Open-label Treatment Group J | 58.8 | 11.8 | 0 | 11.8 | 0 | 0 |
,| Plasmin Open-label Treatment Group M | 50.0 | 0 | 0 | 33.3 | 0 | 0 |
,| Plasminogen Activator Blinded Group E | 77.8 | 22.2 | 11.1 | 33.3 | 11.1 | 11.1 |
Number of Subjects With Symptomatic Intracerebral Hemorrhage
Safety of IV rt-PA as evident by rates of symptomatic ICH defined by an increase of 4 points or more on the NIHSS . (NCT01282242)
Timeframe: Within 7 days from tPA administration.
| Intervention | Participants (Count of Participants) |
|---|
| SIR <1.15 | 1 |
| SIR < 1.25 | 1 |
Number of Subjects With Symptomatic Cerebral Edema
Safety of IV rt-PA as evident by rates of symptomatic cerebral edema defined as brain edema with mass effect as the predominant cause of clinical deterioration. (NCT01282242)
Timeframe: Within 96 hours of tPA administration
| Intervention | Participants (Count of Participants) |
|---|
| SIR <1.15 | 3 |
| SIR < 1.25 | 0 |
Good Clinical Outcome
Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIH stroke scale score at Discharge, a NIH stroke scale score of 0-1 at Discharge; or a 30-day modified Rankin scale score of 0-2 (NCT01429350)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| IV rtPA | 17 |
| IV rtPA and IA Penumbra System | 24 |
Good Functional Outcome as Defined by a Modified Rankin Score of 0-2
The assessor is blinded to patient treatment assignment. (NCT01429350)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| IV rtPA | 14 |
| IV rtPA and IA Penumbra System | 19 |
Incidence of All Serious Adverse Events
"A Serious Adverse Event is defined as an event that:~Led to death~Led to a serious deterioration in the health of the patient that:~Resulted in life-threatening illness or injury~Resulted in permanent impairment of a body structure or a body function~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function~Led to fetal distress, fetal death or a congenital abnormality or birth defect" (NCT01429350)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| IV rtPA | 30 |
| IV rtPA and IA Penumbra System | 18 |
Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage
A symptomatic intracranial hemorrhage is defined as 24 hour CT evidence of an ECASS defined ICH and a 4-point or more worsening of the NIH Stroke Scale score (NCT01429350)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| IV rtPA | 6 |
| IV rtPA and IA Penumbra System | 4 |
Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration
Symptomatic intracranial hemorrhage (sICH) is defined as any evidence of bleeding on CT scan that in the opinion of the treating physician and/or an independent safety monitor is associated with a clinically significant neurological worsening. A four or more point increase in the NIHSS score from baseline (or last score obtained prior to blood found on CT scan) to subsequent CT scan at the time of potential worsening can be used as a guide by the clinical investigator or safety monitor for what represents a significant worsening in neurologic status but sICH can include any worsening deemed significant by the clinical investigator or independent safety monitor. (NCT01464788)
Timeframe: 48-hours
| Intervention | participants (Number) |
|---|
| Low Dose Argatroban + Rt-PA (Alteplase) | 4 |
| High Dose Argatroban + Rt-PA (Alteplase) | 2 |
| Rt-PA (Alteplase) | 3 |
Number of Participants With 0 or 1 on Modified Rankin Scale
Excellent functional outcome as measured by the number of patients with a 0 or 1 on the modified Rankin Scale (mRS) at day 90 as assessed by study personnel blinded to treatment. (NCT01464788)
Timeframe: 90 days
| Intervention | participants (Number) |
|---|
| Low Dose Argatroban + Rt-PA | 9 |
| High Dose Argatroban + Rt-PA | 10 |
| Rt-PA (Alteplase) | 6 |
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis. (NCT01513759)
Timeframe: Baseline, within 48 +/- 6 hours of initiation of therapy
| Intervention | ratio (Mean) |
|---|
| Baseline | Change within 48 +/- 6 hours |
|---|
| EkoSonic® Endovascular System | 1.55 | -0.42 |
Number of Participants With Major Bleeding
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01513759)
Timeframe: From start of study drug infusion up to 72 hours
| Intervention | Participants (Count of Participants) |
|---|
| EkoSonic® Endovascular System | 14 |
Number of Participants Who Died Due to Any Cause
Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported. (NCT01513759)
Timeframe: Baseline up to Day 30
| Intervention | Participants (Count of Participants) |
|---|
| EkoSonic® Endovascular System | 4 |
Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01513759)
Timeframe: Baseline up to Day 30
| Intervention | percentage of participants (Number) |
|---|
| EkoSonic® Endovascular System | 0 |
Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure. (NCT01513759)
Timeframe: Baseline, Hour 48 after initiation of therapy
| Intervention | millimeters of mercury (mmHg) (Mean) |
|---|
| Baseline | Change at Hour 48 |
|---|
| EkoSonic® Endovascular System | 51.4 | -14.4 |
Number of Devices That Could Not be Successfully Used for Infusion
Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure. (NCT01513759)
Timeframe: Baseline up to Day 30
| Intervention | devices (Count of Units) |
|---|
| EkoSonic® Endovascular System | 7 |
Functional Outcome by the Modified Rankin Scale at 90 Days
"The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6.~0, no symptoms at all.~no significant disability despite symptoms; able to carry out all usual duties and activities.~slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.~moderate disability; requiring some help, but able to walk without assistance.~moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.~severe disability; bedridden, incontinent and requiring constant nursing care and attention.~dead." (NCT01643902)
Timeframe: 90 days
| Intervention | units on a scale (Mean) |
|---|
| IV tPA | 1 |
Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment
"Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison.~ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline.~NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage." (NCT01643902)
Timeframe: within 36 hours of treatment
| Intervention | participants (Number) |
|---|
| IV Rt-PA | 0 |
Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days
(NCT01657461)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 59 |
| IV t-PA | 33 |
Death Due to Any Cause at 90 Days
(NCT01657461)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 9 |
| IV t-PA | 12 |
Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage
(NCT01657461)
Timeframe: 27±6 hours post randomization
| Intervention | Correlation (Number) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 0.46 |
Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. (NCT01657461)
Timeframe: Baseline to 27±6 hours post randomization
| Intervention | units on a scale (Mean) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | -8.5 |
| IV t-PA | -3.9 |
Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
(NCT01657461)
Timeframe: Post procedure
| Intervention | Participants (Count of Participants) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 73 |
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
"mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead" (NCT01657461)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| mRS 0 | mRS 1 | mRS 2 | mRS 3 | mRS 4 | mRS 5/6 |
|---|
| IV t-PA | 8 | 10 | 15 | 16 | 20 | 24 |
,| IV t-PA With Solitaire™ Revascularization Device | 17 | 25 | 17 | 12 | 15 | 12 |
Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization
(NCT01657461)
Timeframe: 27±6 hours post randomization
| Intervention | cc (Mean) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 60.2 |
| IV t-PA | 65.9 |
Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization
(NCT01657461)
Timeframe: 27±6 hours post randomization
| Intervention | Reperfusion ratio (Mean) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 81 |
| IV t-PA | 61.9 |
Incidence of sICH at 27±6 Hours Post Randomization
(NCT01657461)
Timeframe: 27±6 hours post randomization
| Intervention | Participants (Count of Participants) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 0 |
| IV t-PA | 3 |
Incidence of All Serious Adverse Events (SAEs)
(NCT01657461)
Timeframe: Through 90 days
| Intervention | Participants (Count of Participants) |
|---|
| IV t-PA With Solitaire™ Revascularization Device | 35 |
| IV t-PA | 30 |
Time to Drain Removal
Time from drain insertion to drain removal. (NCT01717742)
Timeframe: up to 4 months
| Intervention | days (Mean) |
|---|
| Intervention | 6.9 |
| Control | 6.9 |
Time to Hospital Discharge
Time from insertion of the chest drain to discharge from hospital. (NCT01717742)
Timeframe: up to 4 months
| Intervention | days (Mean) |
|---|
| Intervention | 9.0 |
| Control | 9.1 |
Time to Meeting Discharge Criteria
"Time from insertion of the chest drain to meeting discharge criteria.~Discharge criteria:~Chest tube removed~No fever [temperature less than 38°C]~Normal respiratory rate forage~No hypoxia~Drinking fluids wel" (NCT01717742)
Timeframe: up to 4 months
| Intervention | days (Mean) |
|---|
| Intervention | 8.2 |
| Control | 8.5 |
Mortality
Mortality from any cause during the hospitalization for empyema. (NCT01717742)
Timeframe: up to 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 0 |
| Control | 0 |
Cost of the Hospitalization
An economic evaluation will compare the relative costs of DNase-tPA with tPA alone in previously well children who present with pleural empyema, using patient-level data from the trial. (NCT01717742)
Timeframe: up to 4 months
| Intervention | 2018 US $ (Mean) |
|---|
| Intervention | 11329 |
| Control | 10760 |
Duration of Fever After Intervention
Duration of fever (defined as temperature >38 degrees celsius taken by any method) from insertion of the chest drain until resolution. (NCT01717742)
Timeframe: up to 4 months
| Intervention | days (Mean) |
|---|
| Intervention | 2.8 |
| Control | 3.3 |
Number of Participants With Further Interventions
Number of participants who needed further intervention such as placement of another chest drain (by any technique) or surgical intervention such as thoracotomy and decortication, video-assisted thorascopic surgery, or pneumonectomy. (NCT01717742)
Timeframe: up to 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 4 |
| Control | 2 |
Number of Participants With Hospital Readmission
Number of Participants who had any hospital readmission after discharge from hospital for initial treatment for pleural empyema within three months related to pleural empyema or its treatment. (NCT01717742)
Timeframe: 3 months post-discharge
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 2 |
| Control | 0 |
Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention
Number of Participants with need for any kind of ventilatory support or any kind of non-invasive ventilation right after the intervention. (NCT01717742)
Timeframe: up to 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 9 |
| Control | 8 |
Number of Participants With Serious Bleeding
Number of Participants who had intrapleural bleeding resulting in a drop in hemoglobin of greater than 20 g/L or needing a transfusion. (NCT01717742)
Timeframe: up to 4 months
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | 2 |
| Control | 4 |
Mortality and Safety Events: Summary of AE and SAE by MedDRA Code and Grouped by Organ System Within the First 30 Days Post Ictus
By group comparison of the total number of adjudicated adverse events (AE) and serious adverse events (SAE) across all coded organ systems that occurred within the first 30 days post ictus. (NCT01827046)
Timeframe: Day 30
| Intervention | Number of events (Number) |
|---|
| Serious Adverse Events | Adverse Events |
|---|
| Medical Management | 136 | 378 |
,| MIS Plus Rt-PA Management | 123 | 477 |
Patient Disposition: Patient Location at 365 Days Post Ictus (i.e., Good vs. Bad Location) (Adjusted)
"Patient disposition: By group comparison of residential location at day 365 post ictus adjusted for baseline severity.~Good locations refers to home and rehabilitation; and bad locations refers to acute care, long-term care and death." (NCT01827046)
Timeframe: Day 365
| Intervention | Participants (Count of Participants) |
|---|
| Good Location | Bad location |
|---|
| Medical Management | 151 | 98 |
,| MIS Plus Rt-PA Management | 163 | 87 |
Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 180 Days Post Ictus (Adjusted)
"Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 180 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).~The eGOS is a commonly used 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. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3." (NCT01827046)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| eGOS UGR-US (4-8) | eGOS LS-Death (1-3) |
|---|
| Medical Management | 76 | 167 |
,| MIS Plus Rt-PA Management | 81 | 169 |
EuroQol 5 Dimensional Scale (EQ-5D)
By group comparison of EQ-5D at day 365 post ictus. The EuroQol 5 Dimensional Scale (Eq-5D) is a self-reported measure of health status. It is arranged to assess domains related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each domain, codes were 1=no problems, 2=some problems, 3=extreme problems, and 9=unknown. Having a problem in at least 1 domain was coded as 1 (originally represented by 2 or 3) and no problems as 0 (originally represented by 1) . (NCT01827046)
Timeframe: Day 365
| Intervention | Participants (Count of Participants) |
|---|
| Any problem | No problem |
|---|
| Medical Management | 155 | 15 |
,| MIS Plus Rt-PA Management | 176 | 16 |
Dichotomized, Adjudicated, Cross-sectional Modified Rankin Scale (mRS) Score 0-3 vs. 4-6 180 Days Post Ictus (Adjusted)
"Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 180 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).~The mRS is a commonly used 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. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death" (NCT01827046)
Timeframe: Day 180
| Intervention | Participants (Count of Participants) |
|---|
| mRS 0-3 | mRS 4-6 |
|---|
| Medical Management | 93 | 150 |
,| MIS Plus Rt-PA Management | 99 | 151 |
Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted)
"Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 365 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). Ictus refers to symptom onset.~The mRS is a commonly used 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. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death." (NCT01827046)
Timeframe: Day 365
| Intervention | Participants (Count of Participants) |
|---|
| mRS 0-3 | mRS 4-6 |
|---|
| Medical Management | 100 | 140 |
,| MIS Plus Rt-PA Management | 110 | 139 |
Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 365 Days Post Ictus (Adjusted)
"Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 365 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).~The eGOS is a commonly used 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. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3." (NCT01827046)
Timeframe: Day 365
| Intervention | Participants (Count of Participants) |
|---|
| eGOS UGR-US (4-8) | eGOS LS-Death (1-3) |
|---|
| Medical Management | 84 | 150 |
,| MIS Plus Rt-PA Management | 94 | 150 |
Mortality and Safety Events: Adjudicated Bacterial Brain Infection
By group comparison of the percentage of subjects experiencing one or more adjudicated brain bacterial infection events within the first 30 days post randomization. (NCT01827046)
Timeframe: Day 30
| Intervention | Participants (Count of Participants) |
|---|
| MIS Plus Rt-PA Management | 2 |
| Medical Management | 0 |
EQ-VAS
By group comparison of EQ-VAS at day 365 post ictus. The EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where subjects draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine). (NCT01827046)
Timeframe: Day 365
| Intervention | score on a scale (Median) |
|---|
| MIS Plus Rt-PA Management | 70 |
| Medical Management | 70 |
All Cause Mortality Longitudinally From Ictus to 365 Days (Adjusted)
By group comparison of mortality from ictus to 365 days adjusted for baseline severity. (NCT01827046)
Timeframe: Day 365
| Intervention | Participants (Count of Participants) |
|---|
| MIS Plus Rt-PA Management | 48 |
| Medical Management | 62 |
Mortality and Safety Events: Adjudicated Symptomatic Brain Bleeding Within 72 Hours After Last Dose
By group comparison of the percentage of subjects experiencing one or more adjudicated symptomatic brain bleeding events within the first 30 days post randomization. (NCT01827046)
Timeframe: 72 hours after last dose
| Intervention | Participants (Count of Participants) |
|---|
| MIS Plus Rt-PA Management | 6 |
| Medical Management | 3 |
Mortality and Safety Events: All Cause Mortality
By group comparison of mortality from all causes within the first 30 days post randomization. (NCT01827046)
Timeframe: Day 30
| Intervention | Participants (Count of Participants) |
|---|
| MIS Plus Rt-PA Management | 23 |
| Medical Management | 37 |
Mortality and Safety Events: First-week (Operative) Mortality
Mortality and Safety events: By group comparison of mortality within the first 7 days post randomization. (NCT01827046)
Timeframe: Day 7
| Intervention | Participants (Count of Participants) |
|---|
| MIS Plus Rt-PA Management | 2 |
| Medical Management | 10 |
Clot Removal (Amount of Residual Blood)
Relationship between clot removal as an Area Under the Curve (AUC) clot-assessment that estimates the time-averaged clot volume from ictus to end of treatment (EOT i.e. 24 hours after last dose) as AUC clot exposure and functional outcome (proportion 0-3 Modified Rankin Scale (mRS)). (NCT01827046)
Timeframe: 24 hours after last dose
| Intervention | 10mL x days (Mean) |
|---|
| mRS 0-3 | mRS 4-6 |
|---|
| Medical Management | 4.11 | 5.26 |
,| MIS Plus Rt-PA Management | 2.69 | 3.32 |
Mortality and Safety Events: Total Serious Adverse Events (SAE) at 30 Days
By group comparison of the total number of adjudicated serious adverse events that occurred within the first 30 days post randomization. (NCT01827046)
Timeframe: Day 30
| Intervention | Number of events (Number) |
|---|
| MIS Plus Rt-PA Management | 123 |
| Medical Management | 136 |
Patient Disposition: Home Days Over 365 Days Time From Ictus.
By group comparison of cumulative days at home during the 365 days post ictus. (NCT01827046)
Timeframe: During 365 days of follow-up
| Intervention | Days (Median) |
|---|
| MIS Plus Rt-PA Management | 306 |
| Medical Management | 300 |
Type and Intensity of ICU Management: Hospital Days
By group comparison of total number of days in the hospital (NCT01827046)
Timeframe: Up to 365 days
| Intervention | Days (Median) |
|---|
| MIS Plus Rt-PA Management | 17 |
| Medical Management | 17 |
Type and Intensity of ICU Management: ICU Days
By group comparison of cumulative number of days in the Intensive Care Unit (ICU) in a hospital (NCT01827046)
Timeframe: Up to 365 days
| Intervention | Days (Median) |
|---|
| MIS Plus Rt-PA Management | 10 |
| Medical Management | 10 |
Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.
This endpoint was defined as the number of doses required to achieve restored CVAD function in patients from the actilyse treatment group but was analysed as the percentage of participants who achieved restored CVAD function after 1 dose and 2 doses, in patients from the actilyse treatment group. (NCT01958164)
Timeframe: 0 minutes and 240 minutes
| Intervention | percentage of participants (Number) |
|---|
| After 1 dose of Actilyse | After 2 doses of Actilyse |
|---|
| Actilyse | 83.3 | 16.7 |
Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse
Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0) (NCT01958164)
Timeframe: 150 minutes after first drug administration
| Intervention | percentage of participants (Number) |
|---|
| Actilyse | 100.0 |
| Saline Solution + Actilyse | 55.6 |
Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0
Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution) (NCT01958164)
Timeframe: 30 minutes after first drug administration
| Intervention | percentage of participants (Number) |
|---|
| Actilyse | 66.7 |
| Saline Solution + Actilyse | 0.0 |
Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse
Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0) (NCT01958164)
Timeframe: 240 minutes after first drug administration
| Intervention | percentage of participants (Number) |
|---|
| Actilyse | 100.0 |
| Saline Solution + Actilyse | 77.8 |
Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication
Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution). (NCT01958164)
Timeframe: 120 minutes after first drug administration
| Intervention | percentage of participants (Number) |
|---|
| Actilyse | 83.3 |
| Saline Solution + Actilyse | 10.0 |
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0-1, National Institutes of Health Stroke Scale (NIHSS) Score 0-1, Barthel Index [BI] greater than or equal to 95, and Glasgow Outcome Scale [GOS] equal to 1. mRS Score 0-1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales. (NCT02072226)
Timeframe: Day 90
| Intervention | percentage of participants (Number) |
|---|
| mRS 0 - 1 at Day 90 | NIHSS 0 - 1 at Day 90 | BI >= 95 at Day 90 | GOS = 1 at Day 90 |
|---|
| Alteplase + Aspirin Placebo | 78.2 | 85.0 | 79.3 | 81.5 |
,| Alteplase Placebo + Aspirin | 81.5 | 81.7 | 88.7 | 85.6 |
Percentage of Participants With Serious Adverse Events
A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. (NCT02072226)
Timeframe: From baseline to Day 90
| Intervention | percentage of participants (Number) |
|---|
| Alteplase + Aspirin Placebo | 26.0 |
| Alteplase Placebo + Aspirin | 13.1 |
Distribution of Participants Across the Ordinal mRS
mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death before Day 90. Reported are the percentages of participants for all scores on the mRS. (NCT02072226)
Timeframe: Day 90
| Intervention | percentage of participants (Number) |
|---|
| mRS at Day 90 - 0 | mRS at Day 90 - 1 | mRS at Day 90 - 2 | mRS at Day 90 - 3 | mRS at Day 90 - 4 | mRS at Day 90 - 5 or 6 (death) |
|---|
| Alteplase + Aspirin Placebo | 44.9 | 33.3 | 11.5 | 2.6 | 5.1 | 2.6 |
,| Alteplase Placebo + Aspirin | 50.3 | 31.2 | 11.5 | 3.2 | 2.5 | 1.3 |
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02072226)
Timeframe: From baseline up to Day 90: Non-serious adverse events were collected through the Day 30 visit. Serious adverse events were collected through the end of study at Day 90.
| Intervention | percentage of participants (Number) |
|---|
| Alteplase + Aspirin Placebo | 77.3 |
| Alteplase Placebo + Aspirin | 68.0 |
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90
mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS. (NCT02072226)
Timeframe: Day 90
| Intervention | percentage of participants (Number) |
|---|
| Alteplase + Aspirin Placebo | 78.2 |
| Alteplase Placebo + Aspirin | 81.5 |
Percentage of Participants Who Died Due to Stroke and Neurological Disorders
Reported here is the percentage of participants who died due to stroke and neurological disorders. (NCT02072226)
Timeframe: From baseline to Day 90
| Intervention | percentage of participants (Number) |
|---|
| Alteplase + Aspirin Placebo | 0 |
| Alteplase Placebo + Aspirin | 0 |
Overall Mortality
Reported here is the percentage of participants who died due to any cause during the study. (NCT02072226)
Timeframe: From baseline to Day 90
| Intervention | percentage of participants (Number) |
|---|
| Alteplase + Aspirin Placebo | 0.6 |
| Alteplase Placebo + Aspirin | 0 |
Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )
ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration. (NCT02072226)
Timeframe: Within 36 hours after study drug administration on Day 1
| Intervention | percentage of participants (Number) |
|---|
| Alteplase + Aspirin Placebo | 3.2 |
| Alteplase Placebo + Aspirin | 0 |
Percentage of Participants With Any ICH
To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration. (NCT02072226)
Timeframe: Within 36 hours after study drug administration on Day 1
| Intervention | percentage of participants (Number) |
|---|
| Any ICH within 36 hours reported by site | Any ICH within 36 hours reported by central reader |
|---|
| Alteplase + Aspirin Placebo | 7.1 | 7.1 |
,| Alteplase Placebo + Aspirin | 2.6 | 3.3 |
Number of Participants With Major Bleeding
Major bleeding was defined as: Fatal bleeding; and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or bleeding causing a fall in hemoglobin of ≥2.0 grams/deciliter (g/dL), or leading to transfusion of ≥2 units of whole blood or red blood cells. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT02159521)
Timeframe: From start of study drug infusion up to 72 hours
| Intervention | Participants (Count of Participants) |
|---|
| EkoSonic® Endovascular System | 1 |
Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Day 30
Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Limbs with revascularization procedures were considered non-responders. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment), Day 30
| Intervention | percentage of segments (Number) |
|---|
| EkoSonic® Endovascular System | 64 |
Time From Starting Initial Thrombolytic Infusion to Discharge From the Hospital
This Outcome Measure was to measure the time that the participant's initial thrombolytic infusion started to the time the participant was discharged from the hospital. (NCT02159521)
Timeframe: From the time of the EkoSonic® procedure (Day 0) up to 365 days
| Intervention | days (Median) |
|---|
| EkoSonic® Endovascular System | 2 |
Change From Baseline in Blood Flow (Calculated by Time to Washout in the Affected Segment) at Post-Adjunctive Therapy
Change in blood flow was calculated by time to washout in the affected segments in the participants. Time to femoral vein (FV) washout and external iliac vein (EIV) washout was reported. (NCT02159521)
Timeframe: Baseline (Within 30 days of treatment), Day 0
| Intervention | seconds (Mean) |
|---|
| FV washout: Baseline | FV washout: Change at Day 0 | EIV washout: Baseline | EIV washout: Change at Day 0 |
|---|
| EkoSonic® Endovascular System | 4.39 | -2.17 | 3.28 | -0.96 |
Change From Baseline in Ouriel Score (Venous Volumetric Index [VVI]) at Post-Adjunctive Therapy
The Ouriel score was designed to provide a more accurate quantitative estimate of the thrombus mass by calculating a volumetric index for all the venous segments. 10 venous segments were considered. Included segments were the inferior vena cava, common iliac veins, external iliac veins, internal iliac veins, common femoral veins, superficial and deep femoral veins, and popliteal veins and segments of the anterior tibial veins, posterior tibial veins, and peroneal veins. A normalized volumetric score was calculated for each segment by combining measurements from computed tomography, ultrasonography, and venography. Partially occluded veins were assigned a score of one-half the score value for the segment. The score varies from 1 for a single calf vein to 26 for the infrarenal inferior vena cava. The maximum score was 63 per limb. Higher score indicated worse disease prognoses. (NCT02159521)
Timeframe: Baseline (Within 30 days of treatment), Day 0
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Post-EkoSonic® procedure |
|---|
| EkoSonic® Endovascular System | 10.58 | 6.88 |
Number of Treated Limbs With Shift From Baseline in Clinical Stages (Symptomatic and Asymptomatic) of Clinical, Etiologic, Anatomic, Pathophysiological (CEAP) Classification at Days 30, 90, 180, and 365
Status of clinical signs and symptoms of lower limb venous disease was measured by CEAP classification. The CEAP clinical Categories were as follows: C0- no visible or palpable signs of venous disease, C1- telangiectasies or reticular veins, C2- varicose veins, C3- edema, C4a- pigmentation and eczema, C4b- lipodermatosclerosis and atrophie blanche, C5- healed venous ulcer, and C6- active venous ulcer. C0 was of the least clinical concern and C6 was the worst stage. Each clinical class was further characterized by the (clinical stages) presence or absence of symptoms (ache, pain, tightness, skin irritation, heaviness, muscle cramps, as well as other complaints attributable to venous dysfunction): asymptomatic and symptomatic. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment), Days 30, 90, 180, and 365
| Intervention | Limbs (Count of Units) |
|---|
| Baseline to Day 3071961279 | Baseline to Day 9071961279 | Baseline to Day 18071961279 | Baseline to Day 36571961279 |
|---|
| Symptomatic - Asymptomatic | Symptomatic - Symptomatic |
|---|
| EkoSonic® Endovascular System | 67 |
| EkoSonic® Endovascular System | 12 |
| EkoSonic® Endovascular System | 56 |
| EkoSonic® Endovascular System | 19 |
| EkoSonic® Endovascular System | 45 |
| EkoSonic® Endovascular System | 25 |
| EkoSonic® Endovascular System | 40 |
Change From Baseline in Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) Score At Days 30, 90, 180, and 360
The VEINES-QOL/Sym is a participant-based questionnaire designed for self-completion and measures deep vein thrombosis (DVT) impact on symptoms and quality of life from the participants' perspective. It contains 26 items covering participant DVT: symptoms, limitations in daily activities, and psychological impact. A separate summary score VEINES-QOL ranges from 0 (worst quality of life) to 100 (best quality of life). Higher scores indicated a better quality of life. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment), Days 30, 90, 180, and 365
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Day 30 | Change at Day 90 | Change at Day 180 | Change at Day 365 |
|---|
| EkoSonic® Endovascular System | 61.1 | 10.3 | 16.3 | 18.9 | 18.7 |
Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment Procedure
Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment), Day 30
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Day 30 |
|---|
| EkoSonic® Endovascular System | 15.5 | -5.9 |
Change From Baseline in Villalta Score at Days 90, 180, and 365 Post-EkoSonic® Study Treatment Procedure
Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment), Days 90, 180, and 365
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Day 90 | Change at Day 180 | Change at Day 365 |
|---|
| EkoSonic® Endovascular System | 15.5 | -6.9 | -7.8 | -8.2 |
Number of Participants With PTS-induced Admission to an Emergency Room or Unplanned Visits to a Physician's Office or Hospitalization
Number of participants with PTS-induced admission to an emergency room or unplanned visits to a physician's office or hospitalization, are reported. A participant can have more than one PTS-induced health issue. (NCT02159521)
Timeframe: From the time of the EkoSonic® procedure (Day 0) up to 365 days
| Intervention | Participants (Count of Participants) |
|---|
| Total | Emergency Room | Unplanned Physician Office Visit | Hospitalization |
|---|
| EkoSonic® Endovascular System | 24 | 13 | 18 | 8 |
Percentage of Treated Veins Segments of Limbs With Absence of Re-Occlusion, as Documented by Duplex Imaging
Absence of re-occlusion in following treated veins has been reported: common femoral vein (CFV), common iliac vein (CIV), distal femoral vein (FV), external iliac vein (EIV), popliteal vein, and proximal femoral vein (FV). (NCT02159521)
Timeframe: Day 365
| Intervention | percentage of segments (Number) |
|---|
| CFV | CIV | Distal FV | EIV | Popliteal Vein | Proximal FV |
|---|
| EkoSonic® Endovascular System | 100 | 100 | 100 | 100 | 97.9 | 100 |
Number of Participants Who Died Due to Any Cause
Number of participants who died due to any cause for up to 365 days following the conclusion of the study procedure, were reported. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment) up to Day 365
| Intervention | Participants (Count of Participants) |
|---|
| EkoSonic® Endovascular System | 1 |
Number of Participants Who Had Symptomatic PE During Hospitalization for Study Procedure
Symptomatic PE was diagnosed using computed tomography pulmonary angiogram (CTPA), single positron emission computed tomography (SPECT), and ventilation-perfusion (VQ). (NCT02159521)
Timeframe: From starting the initial thrombolytic infusion (Day 0) through discharge from hospital (up to Day 38)
| Intervention | Participants (Count of Participants) |
|---|
| EkoSonic® Endovascular System | 0 |
Number of Participants With at Least 5-Point Reduction From Baseline in Ouriel Score at Post-Adjunctive Therapy
The Ouriel score was designed to provide a more accurate quantitative estimate of the thrombus mass by calculating a volumetric index for all the venous segments. 14 venous segments were considered. Included segments were the inferior vena cava, common iliac veins, external iliac veins, internal iliac veins, common femoral veins, superficial femoral veins, deep femoral veins, and popliteal veins and segments of the anterior tibial veins, posterior tibial veins, and peroneal veins. A normalized volumetric score was calculated for each segment by combining measurements from computed tomography, ultrasonography, and venography. Partially occluded veins were assigned a score of one-half the score value for the segment. The score varies from 1 for a single calf vein to 26 for the infrarenal inferior vena cava. The maximum score was 63 per limb. Higher score indicated worse disease prognoses. (NCT02159521)
Timeframe: Baseline (Within 30 days of treatment), Day 0
| Intervention | Participants (Count of Participants) |
|---|
| EkoSonic® Endovascular System | 0 |
Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Days 90, 180, and 365
Limbs with revascularization procedures were considered non-responders. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment), Days 90, 180, and 365
| Intervention | percentage of segments (Number) |
|---|
| Day 90 | Day 180 | Day 365 |
|---|
| EkoSonic® Endovascular System | 66 | 74 | 74 |
Change From Baseline in Venous Clinical Severity Score (VCSS) in Study Leg at Days 30, 90, 180, and 365
The VCSS system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration, and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 = absent, 1 = mild, 2 = moderate and 3 = severe. Total VCSS was the sum of all VCSS assessment scores from categories for a given time point. Total score ranged from 0 (absent) to 30 (severe). Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline. (NCT02159521)
Timeframe: Baseline (within 30 days of treatment), Days 30, 90, 180, and 365
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Day 30 | Change at Day 90 | Change at Day 180 | Change at Day 365 |
|---|
| EkoSonic® Endovascular System | 12.0 | -3.8 | -4.5 | -5.2 | -5.7 |
Detection of Fibrin Degradation Product (FDP) in the Systemic Circulation
Blood samples will be assayed for FDP (mg/L) during the study. This is a measure of fibrin degradation in the blood and is a value that can be altered by tPA treatment. An FDP (or D-dimer) value <0.5 mg/L is considered normal. (NCT02315898)
Timeframe: FDP will be assessed at screening (if applicable), prior to treatment and then daily during the hospital stay (~1 week) and again at 30 days
| Intervention | mg/L (Mean) |
|---|
| Pre-treatment | Hospital discharge (~1 week) |
|---|
| Treatment-inhaled tPA | 0.32 | 4.14 |
Forced Expiratory Flow 25-75% (FEF25-75)
The FEF25-75 will be assessed for each patient in the treatment arm prior to study drug, during study drug administration (days 0-4), at hospital discharge (~ 1 week after treatment) and again at 30 days. (NCT02315898)
Timeframe: Participants will be assessed at screening (if applicable), just prior to treatment and then daily for the duration of tPA treatment, up to 4 days, at hospital discharge and again at 30 days.
| Intervention | Liters/second (Mean) |
|---|
| Pre-treatment | Treatment (days 0-4) | Hospital discharge (~1 week) |
|---|
| Treatment-inhaled tPA | 1.23 | 1.76 | 1.14 |
Forced Expiratory Volume in One Second (FEV1)
The change in FEV1 (L) from pre- to post- tPA treatment will be assessed for each patient. (NCT02315898)
Timeframe: Participants will be assessed at screening (if applicable), just prior to treatment and then daily for the duration of tPA treatment, up to 4 days, at hospital discharge and again at 30 days.
| Intervention | Liters (Mean) |
|---|
| Pre-treatment | Treatment (days 0-4) | Hospital Discharge (~1 week) |
|---|
| Treatment-inhaled tPA | 1.7 | 1.60 | 1.42 |
Forced Vital Capacity (FVC)
The FVC (L) from prior to, during and after tPA treatment will be assessed for each patient. (NCT02315898)
Timeframe: Participants will be assessed at screening (if applicable), just prior to treatment and then daily for the duration of tPA treatment, up to 4 days, at hospital discharge and again at 30 days.
| Intervention | Liters (Mean) |
|---|
| Pre-treatment | Treatment (days 0-4) | Hospital discharge (~1 week) |
|---|
| Treatment-inhaled tPA | 2.0 | 1.91 | 1.80 |
Requirement for Urgent or Emergent Bronchoscopy
Requirement for urgent or emergent bronchoscopy during treatment was assessed. (NCT02315898)
Timeframe: Participants will be followed for the duration of tPA treatment, up to 4 days.
| Intervention | Participants (Count of Participants) |
|---|
| Treatment-inhaled tPA | 0 |
Frequency of Production/Expectoration of Airway Casts
Episodes of the production of airway casts by participants enrolled in the treatment arm will be assessed. (NCT02315898)
Timeframe: Episodes of cast production will be assessed daily for the duration tPA treatment, up to 4 days and from hospital discharge (~1 week after treatment) up to 30 days
| Intervention | episodes of cast production (30d) (Number) |
|---|
| Treatment-inhaled tPA | 9 |
Primary Endpoint: Number of Subjects That Develop New, Active Bleeding
The number of subjects with new systemic and/or pulmonary and/or gross hematuria (NCT02315898)
Timeframe: Participants will be assessed every 24 hours (daily) for the duration of tPA treatment which was up to 4 days and at hospital discharge which typically occurred within 1 week of treatment initiation.
| Intervention | Participants (Count of Participants) |
|---|
| Treatment-inhaled tPA | 0 |
Requirement for Mechanical Ventilation
Requirement for mechanical ventilation will be assessed in participants enrolled in the treatment arm during the treatment period. (NCT02315898)
Timeframe: Participants will be followed for the duration of tPA treatment, up to 4 days.
| Intervention | Participants (Count of Participants) |
|---|
| Treatment-inhaled tPA | 0 |
Arterial Oxygen Saturation (%)
Changes in oxygen saturation (%) will be monitored by pulse oximetry (oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood). Since this measurement was made at different times for each participant, the mean (SD) oxygen saturation (%) prior to study drug administration (pre-treatment) and at hospital discharge (~ 1 week post-treatment) was calculated. (NCT02315898)
Timeframe: Participants will be assessed at screening (if applicable), just prior to treatment and daily for the duration of tPA treatment, up to 4 days, at hospital discharge (~ 1 week) and again at 30 days.
| Intervention | percent (Mean) |
|---|
| Pre-treatment | Post-treatment (hospital discharge) |
|---|
| Treatment-inhaled tPA | 90.6 | 90.6 |
Changes in the Chest X-ray (CXR)
tPA treatment-induced changes in the CXR will be assessed. The chest x-ray will be scored prior to and after tPA treatment at hospital discharge (~1 week post treatment). The scores will be derived using the Brasfield scoring system which assesses air trapping, linear markings (bronchial wall thickness), bronchiectasis, lobar involvement and overall severity. A score of 25 represents a normal CXR. Points are deducted from 25 for abnormalities so the lower the score the greater the disease severity. (NCT02315898)
Timeframe: A CXR will be acquired and assessed two times during the study- once just prior to the initiation of study drug and again at hospital discharge, up to ~1 week.
| Intervention | score on a scale (0-25 normal) (Mean) |
|---|
| Pre-treatment | Post-treatment |
|---|
| Treatment-inhaled tPA | 20.6 | 20.9 |
Change in Borg Scale Score Before and After 6MW Distance Test at Days 30, 90, and 365
Borg is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) and fatigue experienced before and after the 6MW distance test. Scores ranges from 0 (for no shortness of breath, or no fatigue) to 10 (for the greatest shortness of breath ever experienced, or maximum amount of fatigue felt). Higher scores indicates worse outcome. (NCT02396758)
Timeframe: Days 30, 90, and 365
| Intervention | units on a scale (Median) |
|---|
| Day 30: Dyspnea | Day 30: Fatigue | Day 90: Dyspnea | Day 90: Fatigue | Day 365: Dyspnea | Day 365: Fatigue |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 0.75 | 0.25 | 1 | 0 | 0.25 | 0 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 0 | 0 | 0.5 | 0 | 0.5 | 0 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 0.5 | 0 | 0.5 | 0 | 0 | 0 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 0 | 0 | 0 | 0 | 0 | 0 |
Percentage of Participants With Collapse of the Inferior Vena Cava (IVC) With Respiration at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph
The collapse of IVC was measured at specified timepoints using echocardiogram. (NCT02396758)
Timeframe: Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)
| Intervention | percentage of participants (Number) |
|---|
| Baseline | 4 hrs post-APT | 48 hrs post-APT | Day 30 post-APT | Day 90 post-APT | Day 365 post-APT |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 96.55 | 89.66 | 100.00 | 96.55 | 100.00 | 94.44 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 100.00 | 96.00 | 100.00 | 96.30 | 92.00 | 100.00 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 96.00 | 89.29 | 92.86 | 96.67 | 96.43 | 86.96 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 81.25 | 87.50 | 82.35 | 92.31 | 100.00 | 83.33 |
For Participants of UK Sites: Time From Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for PE
Duration of time between Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for pulmonary embolism (PE) measured in hours for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Baseline through Day 3
| Intervention | hour (Mean) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 25.33 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 24.53 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 30.08 |
Healthcare Resource Utilization: Number of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only)
Number of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Day 30 up to Day 365
| Intervention | Participants (Count of Participants) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 0 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 0 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1 |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 0 |
Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12month Follow-up. (UK Participants Only)
Number of Healthcare Professional (HCP) Specialists involved with care of participant for Venous Thromboembolism (VTE) after hospitalization through 365 days for UK participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Day 30 up to Day 365
| Intervention | HCP visits per participant (Mean) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 1.5 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 1.3 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1.0 |
Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12 Month Follow-up. (UK Participants Only)
Number of Healthcare Professional (HCP) Specialists involved with care of participant for Venous Thromboembolism (VTE) after hospitalization through 365 days for UK participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Day 30 up to Day 365
| Intervention | HCP visits per participant (Mean) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 1.5 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 1.3 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1.0 |
Healthcare Resource Utilization: Duration of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only)
Duration of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Day 30 through Day 365
| Intervention | Days per subject (Mean) |
|---|
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 2 |
For Participants of UK Sites: Time From Hospital Admission to Diagnosis of PE
Duration of time between hospital admission and the diagnosis of pulmonary embolism (PE) measured in hours for UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Baseline through Day 3
| Intervention | hour (Mean) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 10.77 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 9.30 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 7.29 |
For Participants of UK Sites: Freedom From Major Harm Occurring Between Enrolment and 30 Days
Number of UK participants with freedom from major harms assessed by Safety Monitor using the following criteria: 1) Mortality - all cause and PE related; 2) Cardiovascular (CV) collapse defined as one or more of the following: a) Greater than (>) 40 millimeters of mercury (mmHg) drop in systolic blood pressure (SBP) (for >15 minutes from documented blood pressure as an in-patient) despite intravenous (IV) fluid challenge and absence of new atrial arrhythmia; b) Requirement for emergency systemic thrombolysis; c) Requirement for emergency surgical embolectomy ; d) Requirement for vasopressors; e)and/or Intubation/Ventilation; 3) Major bleeding per ISTH; 4) Recurrent PE (confirmed by imaging); and/or 5) Surgical correction of device related complication. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Baseline up to Day 30
| Intervention | Participants (Count of Participants) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 10 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 9 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 9 |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 0 |
Change From Baseline in RV/LV at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph.
An echocardiogram was obtained at specified timepoints to evaluate RV/LV. (NCT02396758)
Timeframe: Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)
| Intervention | Ratio (Mean) |
|---|
| Baseline | Change at 48 hrs post-APT | Change at Day 30 post-APT | Change at Day 90 follow-up | Change at Day 365 follow-up |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 1.19 | -0.23 | -0.38 | -0.41 | -0.44 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 1.20 | -0.29 | -0.37 | -0.39 | -0.46 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1.13 | -0.17 | -0.30 | -0.31 | -0.35 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 1.20 | -0.29 | -0.37 | -0.43 | -0.32 |
Number of Participants With Major Bleeding Within 72 Hours After Initiating the APT Procedure
Criteria for major bleeding events, as defined by the International Society on Thrombosis and Haemostasis (ISTH): 1. Fatal bleeding and/or; 2. Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome) and/or; 3. Bleeding causing a fall in hemoglobin level of 20 grams/liter (g/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells. (NCT02396758)
Timeframe: Day 3 (within 72 hours after initiating the APT procedure)
| Intervention | Participants (Count of Participants) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 0 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 2 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1 |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 2 |
For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge
Levels are defined according to National Framework Document: Level 0 - normal acute ward care (patients whose needs can be met through normal ward care in an acute hospital), Level 1 - acute ward care, with additional advice and support from the critical care team (Patients at risk of their condition deteriorating, or those recently relocated from higher levels of care, whose needs can be met on an acute ward with additional advice from a critical care team), Level 2 - more detailed observation or intervention (requiring more detailed observation or intervention including support for a single failing organ system or post-operative care and those 'stepping down' from higher levels of care) and Level 3 - advanced respiratory support alone, or basic respiratory support together with support of at least two organ systems (includes all complex patients requiring support for multi-organ failure). Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Baseline up to Hospital Discharge
| Intervention | hour (Mean) |
|---|
| Level 0 and 1 | Level 2 | Level 3 |
|---|
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 57.04 | 62.34 | 66.80 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 64.39 | 94.56 | 14.10 |
For Participants of UK Sites:Change in EuroQual - 5 Dimensions - 5 Levels (EQ-5D-5L) Score From Day 30 to Day 365
The EQ-5D-5L consists of 2 parts - the descriptive system (Index Score) and the EQ Visual Analogue scale (VAS Score). The EQ-5D-5L descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Each one digit number expressing the level selected for each dimension is combined into a 5-digit number describing the respondent's heath state. These 5-digit numbers are converted into an index value, where 1 represents full health and 0 is equivalent to death. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale with 100 being the best health imaginable and 0 being the worst health imaginable. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: Day 30, Day 365
| Intervention | units on a scale (Mean) |
|---|
| Day 30 - EQ-5D-5L Index Score | Day 30- EQ-5D-5L VAS Score | Change at Day 365 - EQ-5D-5L Index Score | Change at Day 365 - EQ-5D-5L VAS Score |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 0.732 | 66.7 | 0.039 | -1.6 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 0.819 | 77.8 | -0.107 | -0.4 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 0.934 | 82.5 | -0.042 | 7.1 |
Number of Participants Who Received Oxygen Therapy
Oxygen source is categorized as room air, nasal prongs, mask, and intubated. (NCT02396758)
Timeframe: Days 30, 90, and 365
| Intervention | Participants (Count of Participants) |
|---|
| Day 30: Before 6MW test - Room air | Day 30: After 6MW test - Room air | Day 90: Before 6MW test - Room air | Day 90: After 6MW test - Room air | Day 365: Before 6MW test - Room air | Day 365: After 6MW test - Room air |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 29 | 28 | 26 | 26 | 21 | 21 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 30 | 30 | 30 | 30 | 27 | 28 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 34 | 33 | 36 | 36 | 30 | 30 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 10 | 10 | 10 | 10 | 10 | 10 |
Change in 6 Minute Walk (6MW) Distance From Day 30 to Day 90 and 365
The 6 minute Walk Test is a measure of functional exercise capacity. Participants will be asked to walk as far as possible within a 6-minute period, and the distance covered at the end will be noted and recorded. (NCT02396758)
Timeframe: Days 30, 90, 365
| Intervention | meters (Mean) |
|---|
| Day 30 | Change at Day 90 | Change at Day 365 |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 355.4 | 23.8 | 21.6 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 366.90 | 70.6 | 2.0 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 362.3 | 33.8 | 57.9 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 327.3 | -6.3 | -1.9 |
Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph
The extent of displacement of the tricuspid valves, termed as TAPSE was measured at specified timepoints using echocardiogram. (NCT02396758)
Timeframe: Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)
| Intervention | Millimeters (Mean) |
|---|
| Baseline | Change at 4 hrs post-APT | Change at 48 hrs post-APT | Change at Day 30 post-APT | Change at Day 90 follow-up | Change at Day 365 follow-up |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 16.32 | 0.27 | 2.86 | 5.42 | 6.32 | 6.83 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 17.20 | 0.79 | 1.75 | 5.39 | 3.69 | 5.22 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 16.39 | 0.51 | 2.61 | 2.36 | 3.97 | 4.79 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 18.02 | 2.17 | 3.34 | 2.26 | 2.07 | 3.50 |
Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Score From Day 30 to Day 365
The PEmb-QoL questionnaire contains 6 dimensions that has been created based on the contents of the items, frequency of complaints (Question [Q]1; score range: 1 [every day] to 5 [never]), activities of daily living (ADL) limitations (Q4; score range: 1 [limited a lot] to 3 [not at all]), work-related problems (Q5; response: yes/no), social limitations (Q6; score range: 1 [not at all] to 5 [extremely]), intensity of complaints (Q7 [pain in chest/shoulders]/8 [breathlessness]; score range: 1 [none] to 6 [very serious]) and emotional complaints (Q9; score range: 1 [at all times] to 6 [none of the times]). Total Score for all dimensions are calculated by the sum of the scores for each item of the dimension divided by the number of items. Total score ranges from 1 (better quality of life) to 100 (worst quality of life). Higher scores indicate poorer outcome (decreased quality of life). Questions 1, 4, 5, and 9 are reverse scored. Questions 2 and 3 provide descriptive information. (NCT02396758)
Timeframe: Day 30, Day 365
| Intervention | units on a scale (Mean) |
|---|
| Day 30 | Change at Day 365 |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 38.30 | -16.79 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 27.85 | -8.86 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 24.25 | -8.75 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 25.63 | -12.01 |
Change From Baseline in Thrombus Burden by Modified Miller Score as Assessed by CTA Scan at 48 ± 6 Hours After the Start of the APT Procedure
Modified miller score quantifies thrombus burden on CTA scans. Each segmental pulmonary artery (9 on the right, 7 on the left) that is fully or partly occluded by thrombus is given a score of 1. Any further proximal involves vessels score the number of segmental branches distal to that vessel, thereby giving a modified miller score of 0 (no thrombus) to 16 (thrombus in all segmental arteries or saddle embolism). (NCT02396758)
Timeframe: From Baseline to 48 hrs ± 6 hours
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at 48 hrs post-APT |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 20.72 | -1.24 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 20.00 | -2.20 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 20.92 | -2.62 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 20.44 | -5.22 |
Change From Baseline in Thrombus Burden by Miller Score as Assessed by Pulmonary Arteriogram (PAgram) at Day 0
Miller score is composed of a score for arterial obstruction (objective score) and a score for reduction of peripheral perfusion of lungs (subjective evaluation). Right pulmonary artery (PA) is assigned 9 segmental arteries (3 to the upper, 2 to the middle, and 4 to the lower lobe), and left PA is assigned only 7 segmental arteries (2 to the upper, 2 to the lingula, and 3 to the lower lobe). Presence of segmental emboli, regardless of the degree of obstruction, is scored 1 point. Proximal emboli to the segmental level are scored a value equal to the number of segmental arteries arising distally. Maximal score of obstruction=16. Reduction of peripheral perfusion is scored by dividing each lung into upper, middle, and lower zones and by using a 4-point scale: 0=normal perfusion; 1=moderately reduced perfusion; 2=severely reduced perfusion; 3=no perfusion. Maximal score of reduced perfusion=18. Thus, the maximal Miller score =34. Higher Miller score=more thrombus burden. (NCT02396758)
Timeframe: Baseline, Day 0 (within 4 hours after APT end)
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at 4 hrs post-APT |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 23.71 | -1.00 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 23.29 | -2.29 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 24.21 | -3.11 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 22.93 | -9.20 |
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio to 48 ± 6 Hours After the Start of the APT Procedure
Change from baseline in RV/LV will be determined by computed tomographic angiography (CTA). (NCT02396758)
Timeframe: Change from Baseline to 48 hrs ± 6 hours
| Intervention | ratio (Mean) |
|---|
| Baseline | Change at 48 ± 6 hours |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 1.53 | -0.43 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 1.47 | -0.37 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1.52 | -0.41 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 1.51 | -0.48 |
Change From Baseline in Estimated Right Ventricular Systolic Pressure (RVSP) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph
RVSP was measured at specified timepoints using echocardiogram. (NCT02396758)
Timeframe: Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)
| Intervention | Millimeters (Mean) |
|---|
| Baseline | Change at 4 hrs post-APT | Change at 48 hrs post-APT | Change at Day 30 post-APT | Change at Day 90 follow-up | Change at Day 365 follow-up |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 31.59 | -2.18 | 0.98 | -7.92 | -8.30 | -9.78 |
,| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 36.64 | -10.87 | -5.35 | -13.84 | -15.60 | -12.87 |
,| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 35.57 | -3.54 | -9.31 | -14.06 | -16.39 | -18.96 |
,| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 25.75 | 2.13 | -7.80 | -4.86 | -7.08 | -7.16 |
Percentage of Participants With Treatment Success of an APT Procedure
Treatment success of an APT procedure will be assessed by an Adjudication Committee that is blinded to the participant's treatment. The criteria for treatment success are defined as follows: A decrease in RV/LV from baseline to 48 hours after the start of the procedure of at least 0.2; and no life-threatening adverse events related to PE or its treatment through 30 days after the start of the APT procedure. (NCT02396758)
Timeframe: From Baseline up to Day 30
| Intervention | Percentage of participants (Number) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 73.9 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 68.0 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 69.2 |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 61.6 |
Number of Participants With Symptomatic Recurrent Pulmonary Embolism (Per Adjudication)
Number of participants with symptomatic recurrent pulmonary embolism up to 365 days following the APT procedure, were reported. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT02396758)
Timeframe: From Baseline up to Day 365
| Intervention | Participants (Count of Participants) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 0 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 1 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1 |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 0 |
Number of Participants Who Encountered Technical Procedural Complications
Technical complications associated with the use of the EKOS device will be recorded during catheter placement in the pulmonary artery and during the infusion procedure. (NCT02396758)
Timeframe: From device placement through Day 2
| Intervention | Participants (Count of Participants) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 0 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 0 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 1 |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 0 |
Number of Participants Who Die Due to Any Cause
Number of participants who died due to any cause for up to 365 days following the APT procedure, were reported. (NCT02396758)
Timeframe: From Baseline up to Day 365
| Intervention | Participants (Count of Participants) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 1 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 1 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 0 |
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | 1 |
Healthcare Resource Utilization: Team Managing the Participant During Hospitalization - Number of Healthcare Professional (HCP) Specialties Involved. (UK Participants Only)
Number of Healthcare Professional (HCP) Specialists involved with care of participant during hospitalization of UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Baseline up to Day 365
| Intervention | HCP per participant (Mean) |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 3.9 |
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | 4.2 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter | 4.0 |
For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge
Levels are defined according to National Framework Document: Level 0 - normal acute ward care (patients whose needs can be met through normal ward care in an acute hospital), Level 1 - acute ward care, with additional advice and support from the critical care team (Patients at risk of their condition deteriorating, or those recently relocated from higher levels of care, whose needs can be met on an acute ward with additional advice from a critical care team), Level 2 - more detailed observation or intervention (requiring more detailed observation or intervention including support for a single failing organ system or post-operative care and those 'stepping down' from higher levels of care) and Level 3 - advanced respiratory support alone, or basic respiratory support together with support of at least two organ systems (includes all complex patients requiring support for multi-organ failure). Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. (NCT02396758)
Timeframe: From Baseline up to Hospital Discharge
| Intervention | hour (Mean) |
|---|
| Level 0 and 1 | Level 2 |
|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | 74.64 | 86.77 |
Average Time to rtPA
(NCT02752256)
Timeframe: 24 hours
| Intervention | Minutes (Mean) |
|---|
| Intervention/Transfer | 74.5 |
| Control | 60 |
Percentage of Participants With a rtPA Protocol Violation
Protocol violations can include any of the following recorded outcomes: inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight, intracranial bleeding, and angioedema (NCT02752256)
Timeframe: 24 hours
| Intervention | Participants (Count of Participants) |
|---|
| Intervention/Transfer | 7 |
| Control | 0 |
The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema
The percentage of patients with incidence of cerebral herniation and symptomatic edema. (NCT02930837)
Timeframe: 90 days
| Intervention | Percentage of patients (Number) |
|---|
| Alteplase (Rt-PA) | 4.2 |
The Percentage of Patients With Severity of Adverse Events
The percentage of patients with severity of adverse events (AEs). The percentage of patients with different categories of AEs are presented. (NCT02930837)
Timeframe: On-treatment period, that is, within 7 days from the start of bolus
| Intervention | Percentage of patients (Number) |
|---|
| Any AE | Severe AE | Investigator defined drug-related AEs | AEs leading to discontinuation of study drug | Serious AEs | Results in death | Immediately life threatening | Persistent or significant disability/ incapacity | Required/prolonged hospitalization | Congenital anomaly/ birth defect | Other comparable medical criteria |
|---|
| Alteplase (Rt-PA) | 85.8 | 20.8 | 12.5 | 0.0 | 10.0 | 4.2 | 3.3 | 1.7 | 5.0 | 0.0 | 0.0 |
Patient Survival Probability at Visit 5 (Censoring at Day 90)
Patient survival probability at visit 5 (censoring at day 90). The percentage of patients who died until Day 1, Day 7, Day 30, Day 90. (NCT02930837)
Timeframe: 90 days
| Intervention | Percentage of patients (Number) |
|---|
| Day 0-1 | Day 2-7 | Day 8-30 | Day 31-90 |
|---|
| Alteplase (Rt-PA) | 0.0 | 3.3 | 1.7 | 0.0 |
The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
Percentage of global outcome responder at day 90 if he/she obtains the following results at day 90 for the endpoints mRS score of 0 to 1; Barthel Index score >= 95; NIHSS score of 0 to 1; Glasgow Outcome Scale score of 1. mRS: 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead. NIHSS is composed of 11 items, and for each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Glasgow Outcome Score applies to patients with brain damage allowing the objective assessment of their recovery in five categories: 1 Good Recovery, 2 Moderately Disabled, 3 Severely Disabled, 4 Vegetative State, 5 Dead. Barthel Index score to measure performance in activities of daily living with the scale ranging from 0 to 100. Global outcome response is the intersection of above four respective outcomes. (NCT02930837)
Timeframe: 90 days
| Intervention | Percentage of patients (Number) |
|---|
| Global outcome response | A response of 0 or 1 on mRS | A response of least 95 on the Barthel index score | A response of 0 or 1 on NIHSS | A Glasgow outcome of 1 |
|---|
| Alteplase (Rt-PA) | 55.0 | 63.3 | 65.8 | 56.7 | 69.2 |
The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
The percentage of patients with symptomatic intracranial haemorrhage (sICH) centrally evaluated by data-monitoring committee (DMC) consultants according to European Cooperative Acute Stroke Study (ECASS) III definition within the whole study period. According to the protocol, sICH (ECASS III criteria) was defined as: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration (defined by an increase in the NIHSS score of 4 or more points), or that led to death and that was identified as the predominant cause of the neurological deterioration. sICH event was firstly evaluated by investigator. The DMC consultants evaluated all the patients with NIHSS score increase of at least 4 any time after treatment (including all fatal patients and sICH events evaluated by investigator). Wilson score confidence interval is presented. (NCT02930837)
Timeframe: 90 days
| Intervention | Percentage of patients (Number) |
|---|
| Day 0-1 | Day 2-7 | Day 8-30 | Day 31-90 | Day>90 |
|---|
| Alteplase (Rt-PA) | 2.5 | 0.0 | 0.0 | 0.0 | 0.0 |
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
The percentage of patients with modified Rankin Scale (mRS 0-1) (favourable outcome) response at Visit 5 (Day 90) after stroke onset by face-to-face interview with patient. Modified Rankin Scale (mRS): 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead. (NCT02930837)
Timeframe: 90 days
| Intervention | Percentage of patients (Number) |
|---|
| No symptom at all | No sign. disability | Slight disability | Moderate disability | Moderate Severe disability | Severe disability | Dead |
|---|
| Alteplase (Rt-PA) | 42.5 | 20.8 | 8.3 | 14.2 | 1.7 | 7.5 | 5.0 |
Duration of Hospital Stay After Intervention
duration of hospital stay in days from time of procedure to discharge from hospital. (NCT03468933)
Timeframe: 12 week follow up period
| Intervention | days (Median) |
|---|
| Fibrinolytic Therapy Group | 4 |
| Medical Thoracoscopy Group | 2 |
Number of Participants Necessitating Intervention After the Assigned Treatment
"Need for surgical intervention (VATS, Open Thoracotomy) in any arm~Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure~Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure" (NCT03468933)
Timeframe: 12 week follow up period
| Intervention | Participants (Count of Participants) |
|---|
| Fibrinolytic Therapy Group | 3 |
| Medical Thoracoscopy Group | 4 |
Total Length of Hospital Stay
Total days spent in the hospital (NCT03468933)
Timeframe: 12 week follow up period
| Intervention | days (Median) |
|---|
| Fibrinolytic Therapy Group | 6 |
| Medical Thoracoscopy Group | 3.5 |
In Hospital and 30-day Mortality
Death of a patient while being hospitalized or up to 30 days after (NCT03468933)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Fibrinolytic Therapy Group | 0 |
| Medical Thoracoscopy Group | 1 |
Adverse Events
any Adverse events (pain, bleeding) (NCT03468933)
Timeframe: 12 week follow up period
| Intervention | Participants (Count of Participants) |
|---|
| Fibrinolytic Therapy Group | 1 |
| Medical Thoracoscopy Group | 1 |
Episodes of CVC Dysfunction
Episodes of CVC dysfunction (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | episodes (Number) |
|---|
| Alteplase | 5 |
| Heparin | 2 |
Clinical Bleeding
clinically significant bleeding (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | episodes (Number) |
|---|
| Alteplase | 0 |
| Heparin | 0 |
Catheter-associated Bloodstream Infection
CLABSI (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | Participants (Count of Participants) |
|---|
| Alteplase | 0 |
| Heparin | 0 |
Off Study Use of t-PA
off study use (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | doses (Median) |
|---|
| Alteplase | 0.5 |
| Heparin | 0 |
Catheter-associated Venous Thrombosis
Catheter-associated Venous Thrombosis upon ICU discharge or 30 days (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | Participants (Count of Participants) |
|---|
| Alteplase | 3 |
| Heparin | 3 |
PaO2/FiO2 Ratio at 24 Hours
PaO2/FiO2 ratio measured at 24 hours post-randomization (NCT04357730)
Timeframe: 24 hours post-randomization
| Intervention | ratio (Median) |
|---|
| Phase 1 Control | 146.7 |
| Alteplase-50 Bolus | 144 |
PaO2/FiO2 Change (Increase) From Pre-to-post Intervention
PaO2/FiO2 change (increase) from pre-to-post intervention at 48 hours post randomization. Ideally, the PaO2/FiO2 will be measured with the patient in the same prone/supine position as in baseline, as change in positions may artificially reduce the change (increase) attributable to the study drug. However, given the pragmatic nature of the trial, the prone/supine position will be determined by the attending physician, in which case, we will use as an outcome the PaO2/FiO2 closest to the 48 hours obtained prior to the change in position as the outcome. (NCT04357730)
Timeframe: at 48 hours post randomization
| Intervention | percent change (Median) |
|---|
| Phase 1 Control | 16.9 |
| Alteplase-50 Bolus | 29.8 |
| Phase 2 Control | -11.9 |
| Alteplase-50 Drip | -19.6 |
PaO2/FiO2 at 48 Hours
PaO2/FiO2 ratio measured at 48 hours post-randomization (NCT04357730)
Timeframe: 48 hours post-randomization
| Intervention | ratio (Median) |
|---|
| Phase 1 Control | 125 |
| Alteplase-50 Bolus | 157.1 |
| Phase 2 Control | 113.7 |
| Alteplase-50 Drip | 103.5 |
PaO2/FiO2 at 24 Hours
PaO2/FiO2 ratio measured at 24 hours post-randomization (NCT04357730)
Timeframe: 24 hours post-randomization
| Intervention | ratio (Median) |
|---|
| Phase 2 Control | 119.2 |
| Alteplase-50 Drip | 94.5 |
Number of Patients Who Required Paralytics 48 Hours Post-randomization
Number of patients who required paralytics 48 hours post-randomization (NCT04357730)
Timeframe: 48 hours post-randomization
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Control | 10 |
| Alteplase-50 Bolus | 8 |
| Phase 2 Control | 6 |
| Alteplase-50 Drip | 4 |
Number of Participants With Adverse Events
Number of Participants with Adverse Events (NCT04357730)
Timeframe: Duration of hospital stay, up to 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Control | 13 |
| Alteplase-50 Bolus | 13 |
| Phase 2 Control | 5 |
| Alteplase-50 Drip | 2 |
National Early Warning Score 2 (NEWS2)
NEWS2 is a standardised clinical scoring system developed to improve detection of deterioration in acutely ill patients. It is based on aggregate scoring of six physiological parameters; respiratory rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion, and body temperature. A NEWS2 score of 5 or 6 is considered a key threshold that may indicate clinical deterioration and should prompt urgent response by a clinician or a team with competence in assessment and treatment of acutely ill patients.The total score range is 0 to 20. (NCT04357730)
Timeframe: at 48 hours post randomization
| Intervention | percent change (Median) |
|---|
| Phase 1 Control | 0 |
| Alteplase-50 Bolus | 0 |
| Phase 2 Control | -12.5 |
| Alteplase-50 Drip | 65.7 |
INR at 24 Hours
This outcome measure shows patients' median INR at 24 hours post randomization. (NCT04357730)
Timeframe: at 24 hours post randomization
| Intervention | ratio (Median) |
|---|
| Phase 1 Control | 1.3 |
| Alteplase-50 Bolus | 1.2 |
| Phase 2 Control | 1.1 |
| Alteplase-50 Drip | 1.1 |
aPTT at 48 Hours
This outcome measure shows patients' median aPTT at 48 hours post randomization. (NCT04357730)
Timeframe: at 48 hours post randomization
| Intervention | seconds (Median) |
|---|
| Phase 1 Control | 30 |
| Alteplase-50 Bolus | 64.3 |
| Phase 2 Control | 53.1 |
| Alteplase-50 Drip | 33 |
D-dimer at 48 Hours
This outcome measure shows patients' median D-dimer (ng/mL) at 48 hours post randomization. (NCT04357730)
Timeframe: at 48 hours post randomization
| Intervention | ng/mL (Median) |
|---|
| Phase 1 Control | 1326 |
| Alteplase-50 Bolus | 1975 |
| Phase 2 Control | 3480.5 |
| Alteplase-50 Drip | 4957.5 |
Intensive Care Unit (ICU) Days
(NCT04357730)
Timeframe: Duration of hospital stay, up to 28 days
| Intervention | days (Median) |
|---|
| Phase 1 Control | 18 |
| Alteplase-50 Bolus | 16 |
| Phase 2 Control | 27 |
| Alteplase-50 Drip | 19 |
Fibrinogen at 24 Hours
This outcome measure shows patients' median Fibrinogen (mg/dL) at 24 hours post randomization. (NCT04357730)
Timeframe: at 24 hours post randomization
| Intervention | mg/dL (Median) |
|---|
| Phase 1 Control | 595 |
| Alteplase-50 Bolus | 627 |
| Phase 2 Control | 588.5 |
| Alteplase-50 Drip | 612 |
INR at 48 Hours
This outcome measure shows patients' median INR at 48 hours post randomization. (NCT04357730)
Timeframe: at 48 hours post randomization
| Intervention | ratio (Median) |
|---|
| Phase 1 Control | 1.2 |
| Alteplase-50 Bolus | 1.2 |
| Phase 2 Control | 1.2 |
| Alteplase-50 Drip | 1.2 |
28 Days In-hospital Mortality
28 days mortality for hospitalized patients (NCT04357730)
Timeframe: 28 days post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Control | 5 |
| Alteplase-50 Bolus | 4 |
| Phase 2 Control | 4 |
| Alteplase-50 Drip | 4 |
Ventilation Days
Number of days patient required ventilation support (NCT04357730)
Timeframe: Duration of hospital stay, up to 28 days
| Intervention | days (Median) |
|---|
| Phase 1 Control | 18 |
| Alteplase-50 Bolus | 13 |
| Phase 2 Control | 24.5 |
| Alteplase-50 Drip | 17.5 |
Fibrinogen at 48 Hours
This outcome measure shows patients' median Fibrinogen (mg/dL) at 48 hours post randomization. (NCT04357730)
Timeframe: at 48 hours post randomization
| Intervention | mg/dL (Median) |
|---|
| Phase 1 Control | 612 |
| Alteplase-50 Bolus | 567 |
| Phase 2 Control | 480.5 |
| Alteplase-50 Drip | 698.5 |
Achievement of PaO2/FiO2 ≥ 200 or 50% Increase in PaO2/FiO2
Number of Participants with Achievement of PaO2/FiO2 ≥ 200 or 50% Increase in PaO2/FiO2 (whatever is lower) (NCT04357730)
Timeframe: at 48 hours post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Control | 2 |
| Alteplase-50 Bolus | 9 |
| Phase 2 Control | 3 |
| Alteplase-50 Drip | 1 |
aPTT at 24 Hours
This outcome measure shows patients' median aPTT at 24 hours post randomization. (NCT04357730)
Timeframe: at 24 hours post randomization
| Intervention | seconds (Median) |
|---|
| Phase 1 Control | 32.9 |
| Alteplase-50 Bolus | 51.7 |
| Phase 2 Control | 35.6 |
| Alteplase-50 Drip | 27.7 |
Number of Participants With Bleeding Events
Number of Participants with Bleeding Events (NCT04357730)
Timeframe: Duration of hospital stay, up to 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1 Control | 2 |
| Alteplase-50 Bolus | 3 |
| Phase 2 Control | 1 |
| Alteplase-50 Drip | 0 |
D-dimer at 24 Hours
This outcome measure shows patients' median D-dimer (ng/mL) at 24 hours post randomization. (NCT04357730)
Timeframe: at 24 hours post randomization
| Intervention | ng/mL (Median) |
|---|
| Phase 1 Control | 1426 |
| Alteplase-50 Bolus | 2296 |
| Phase 2 Control | 3855 |
| Alteplase-50 Drip | 8477 |
ICU-free Days
ICU-free days will be calculated based on (28 - number of days spent in the ICU) formula (NCT04357730)
Timeframe: 28 days of hospital stay or until hospital discharge (whichever comes first)
| Intervention | days (Median) |
|---|
| Phase 1 Control | 0 |
| Alteplase-50 Bolus | 6 |
| Phase 2 Control | 0 |
| Alteplase-50 Drip | 0 |
Ventilator-free Days
Ventilator-free days will be calculated based on (28 - number of days on mechanical ventilation) formula. (NCT04357730)
Timeframe: 28 days of hospital stay or until hospital discharge (whichever comes first)
| Intervention | days (Median) |
|---|
| Phase 1 Control | 0 |
| Alteplase-50 Bolus | 12 |
| Phase 2 Control | 0 |
| Alteplase-50 Drip | 0 |
Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax)
Maximum measured concentration of Alteplase in plasma (Cmax) is reported. (NCT04419493)
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
| Intervention | nanogram / milliliter (ng/mL) (Geometric Least Squares Mean) |
|---|
| Part B: Alteplase, TPA -02 | 738.35 |
| Part B: Alteplase, TPA-05 | 781.24 |
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of alteplase in plasma over the interval from 0 extrapolated to infinity is reported. (NCT04419493)
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
| Intervention | hour*nanogram/milliliter (h*ng/mL) (Geometric Least Squares Mean) |
|---|
| Part B: Alteplase, TPA -02 | 371.85 |
| Part B: Alteplase, TPA-05 | 379.90 |
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)
The area under the concentration-time curve of Alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. (NCT04419493)
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
| Intervention | hour * nanogram / milliliter (h*ng/mL) (Geometric Least Squares Mean) |
|---|
| Part B: Alteplase, TPA -02 | 369.21 |
| Part B: Alteplase, TPA-05 | 377.35 |