Page last updated: 2024-11-05

ticlopidine and Body Weight

ticlopidine has been researched along with Body Weight in 22 studies

Ticlopidine: An effective inhibitor of platelet aggregation commonly used in the placement of STENTS in CORONARY ARTERIES.
ticlopidine : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group.

Body Weight: The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.

Research Excerpts

ExcerptRelevanceReference
"Body weight is a predictor of clopidogrel response."9.19Higher body weight patients on clopidogrel maintenance therapy have lower active metabolite concentrations, lower levels of platelet inhibition, and higher rates of poor responders than low body weight patients. ( Angiolillo, DJ; Bergmeijer, TO; Brown, P; Erlinge, D; Jakubowski, JA; James, S; Moser, BA; Small, DS; Ten Berg, JM; Wagner, H; Winters, KJ; Zhou, C, 2014)
" Patients with an episode of noncardioembolic ischemic stroke at least 8 days prior to randomization, who were aged <75 years or had a body weight >50 kg were randomized to 50 or 75 mg clopidogrel once daily for 52 weeks."9.16Clopidogrel two doses comparative 1-year assessment of safety and efficacy (COMPASS) study in Japanese patients with ischemic stroke. ( Minematsu, K; Tanahashi, N; Uchiyama, S, 2012)
"Bleeding is the most common adverse reaction to aspirin and can lead to drug discontinuation or even be life-threatening in the secondary prevention of stroke or transient ischemic attack."8.12Effect of body weight on bleeding events of aspirin in ischemic stroke or transient ischemic attack patients. ( Cheng, J; Deng, X; Li, H; Ma, Y; Shi, T; Wang, X; Wu, Y; Zhang, Z; Zhu, Q, 2022)
"The systemic treatment effects of OP-1206 alpha-CD (17S-20-dimethyl-trans-delta 2-PGE1 alpha-cyclodextrin clathrate), a prostaglandin E1 (PGE1) analogue, on walking dysfunction, spinal cord blood flow (SCBF) and skin blood flow (SKBF) were assessed in the rat neuropathic intermittent claudication (IC) model in comparison with nifedipine (dimethyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate), ticlopidine (5-[(2-chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno[3,2-C]pyridine hydrochloride) and cilostazol (6-[4-(1-cyclohexyl-1H-tetrazol-5-yl)-butoxy]-3,4-dihydro-2(1H)-quinolinone)."7.72Effects of OP-1206 alpha-CD on walking dysfunction in the rat neuropathic intermittent claudication model: comparison with nifedipine, ticlopidine and cilostazol. ( Akimaru, S; Ito, H; Katsube, N; Maegawa, H; Marsala, M; Nakai, K; Takenobu, Y; Takimizu, H, 2003)
"Body weight is a predictor of clopidogrel response."5.19Higher body weight patients on clopidogrel maintenance therapy have lower active metabolite concentrations, lower levels of platelet inhibition, and higher rates of poor responders than low body weight patients. ( Angiolillo, DJ; Bergmeijer, TO; Brown, P; Erlinge, D; Jakubowski, JA; James, S; Moser, BA; Small, DS; Ten Berg, JM; Wagner, H; Winters, KJ; Zhou, C, 2014)
"We identified 9 independent risk factors for SICH: baseline National Institutes of Health Stroke Scale, serum glucose, systolic blood pressure, age, body weight, stroke onset to treatment time, aspirin or combined aspirin and clopidogrel, and history of hypertension."5.16Predicting the risk of symptomatic intracerebral hemorrhage in ischemic stroke treated with intravenous alteplase: safe Implementation of Treatments in Stroke (SITS) symptomatic intracerebral hemorrhage risk score. ( Ahmed, N; Egido, JA; Ford, GA; Lees, KR; Mazya, M; Mikulik, R; Toni, D; Wahlgren, N, 2012)
" Patients with an episode of noncardioembolic ischemic stroke at least 8 days prior to randomization, who were aged <75 years or had a body weight >50 kg were randomized to 50 or 75 mg clopidogrel once daily for 52 weeks."5.16Clopidogrel two doses comparative 1-year assessment of safety and efficacy (COMPASS) study in Japanese patients with ischemic stroke. ( Minematsu, K; Tanahashi, N; Uchiyama, S, 2012)
"Patients with medically managed unstable angina or non-ST-segment elevation myocardial infarction were enrolled in the TRILOGY ACS trial (2008 to 2011) comparing clopidogrel vs prasugrel."5.16Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. ( Armstrong, PW; Brown, E; Chan, MY; Cornel, JH; Erlinge, D; Fox, KA; Goodman, SG; Gurbel, PA; Huber, K; Jakubowski, JA; Neely, B; Neely, M; Ohman, EM; Prabhakaran, D; Roe, MT; Tantry, US; White, HD; Zhou, C, 2012)
"Oral antiplatelet therapy with clopidogrel and aspirin is an important and widely prescribed strategy to prevent ischemic events in patients with cardiovascular diseases."4.85Recent developments in clopidogrel pharmacology and their relation to clinical outcomes. ( Antonino, MJ; Gurbel, PA; Tantry, US, 2009)
"Bleeding is the most common adverse reaction to aspirin and can lead to drug discontinuation or even be life-threatening in the secondary prevention of stroke or transient ischemic attack."4.12Effect of body weight on bleeding events of aspirin in ischemic stroke or transient ischemic attack patients. ( Cheng, J; Deng, X; Li, H; Ma, Y; Shi, T; Wang, X; Wu, Y; Zhang, Z; Zhu, Q, 2022)
"In this blinded, 3-period, crossover study in stable patients with coronary artery disease (CAD) taking aspirin, prasugrel 5 and 10 mg and clopidogrel 75 mg were administered to LBW (56."3.78Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients: results from the FEATHER trial. ( Angiolillo, DJ; Bergmeijer, T; Brown, PB; Erlinge, D; Foley, D; Jakubowski, JA; James, S; Luo, J; Moser, B; Small, DS; Ten Berg, J; Wagner, H; Winters, KJ; Zhou, C, 2012)
"Data obtained in this study suggest a suboptimal clopidogrel response in patients with greater body weight and body mass index."3.77Body weight: a risk factor for subtherapeutic antithrombotic therapy in neurovascular stenting. ( Alexander, MJ; Choulakian, A; Drazin, D; Kornbluth, P; Nuño, M, 2011)
"The systemic treatment effects of OP-1206 alpha-CD (17S-20-dimethyl-trans-delta 2-PGE1 alpha-cyclodextrin clathrate), a prostaglandin E1 (PGE1) analogue, on walking dysfunction, spinal cord blood flow (SCBF) and skin blood flow (SKBF) were assessed in the rat neuropathic intermittent claudication (IC) model in comparison with nifedipine (dimethyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate), ticlopidine (5-[(2-chlorophenyl)methyl]-4,5,6,7-tetrahydrothieno[3,2-C]pyridine hydrochloride) and cilostazol (6-[4-(1-cyclohexyl-1H-tetrazol-5-yl)-butoxy]-3,4-dihydro-2(1H)-quinolinone)."3.72Effects of OP-1206 alpha-CD on walking dysfunction in the rat neuropathic intermittent claudication model: comparison with nifedipine, ticlopidine and cilostazol. ( Akimaru, S; Ito, H; Katsube, N; Maegawa, H; Marsala, M; Nakai, K; Takenobu, Y; Takimizu, H, 2003)
" The therapeutic usefulness of clopidogrel has been limited by documented inter-individual heterogeneity in platelet inhibition, which may be attributable to known clopidogrel pharmacokinetic variability."2.73Smoking behaviour modulates pharmacokinetics of orally administered clopidogrel. ( Al-Zumyli, R; Arafat, T; Bulatova, NR; Yousef, AM, 2008)
"Despite a lack of clear recommendations to guide decision-making, reductions in enoxaparin sodium dosage in the elderly and in patients with mild and moderate renal dysfunction are common in patients with acute coronary syndrome."1.35Factors associated with bleeding in elderly hospitalized patients treated with enoxaparin sodium : a prospective, open-label, observational study. ( Beckerman, P; Ben-Artzi, M; Ben-Yehuda, A; Haber, G; Levin, A; Muszkat, M; Varon, D, 2009)
"In the AA-induced sudden death model, 30 min after beraprost administration (1 or 3 mg/kg, po), AA was injected into the rabbit internal carotid artery, and incidence of convulsion and sudden death were assessed."1.28The effects of beraprost Na, a stable prostacyclin analog, on animal models of stroke. ( Hirano, T; Kanai, N; Nishio, S; Umetsu, T; Yamori, Y, 1992)

Research

Studies (22)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (4.55)18.2507
2000's8 (36.36)29.6817
2010's12 (54.55)24.3611
2020's1 (4.55)2.80

Authors

AuthorsStudies
Wang, X1
Zhu, Q1
Wu, Y1
Li, H1
Deng, X1
Cheng, J1
Zhang, Z1
Ma, Y1
Shi, T1
Wagner, H2
Angiolillo, DJ4
Ten Berg, JM2
Bergmeijer, TO1
Jakubowski, JA4
Small, DS3
Moser, BA2
Zhou, C4
Brown, P1
James, S3
Winters, KJ3
Erlinge, D4
Brown, PB2
Vengoechea, F1
Olivier, CB1
Schnabel, K1
Weber, S1
Zhou, Q1
Bode, C1
Moser, M1
Diehl, P1
Yousef, AM1
Arafat, T1
Bulatova, NR1
Al-Zumyli, R1
Levin, A1
Ben-Artzi, M1
Beckerman, P1
Haber, G1
Varon, D1
Ben-Yehuda, A1
Muszkat, M1
Gurbel, PA2
Antonino, MJ1
Tantry, US2
Aleil, B1
Léon, C1
Cazenave, JP1
Gachet, C2
Takeda, M1
Yamashita, T1
Shinohara, M1
Sasaki, N1
Tawa, H1
Nakajima, K1
Momose, A1
Hirata, K1
Drazin, D1
Choulakian, A1
Nuño, M1
Kornbluth, P1
Alexander, MJ1
Mazya, M1
Egido, JA1
Ford, GA1
Lees, KR1
Mikulik, R1
Toni, D1
Wahlgren, N1
Ahmed, N1
Morel, O1
El Ghannudi, S1
Hess, S1
Reydel, A1
Crimizade, U1
Jesel, L1
Radulescu, B1
Wiesel, ML1
Ohlmann, P1
Uchiyama, S1
Tanahashi, N1
Minematsu, K1
Ten Berg, J1
Foley, D1
Luo, J1
Moser, B1
Bergmeijer, T1
Ohman, EM1
Neely, B1
Neely, M1
Goodman, SG1
Huber, K1
Chan, MY1
Cornel, JH1
Brown, E1
White, HD1
Fox, KA1
Prabhakaran, D1
Armstrong, PW1
Roe, MT1
Fihn, SD1
Gardin, JM1
Abrams, J1
Berra, K1
Blankenship, JC1
Dallas, AP1
Douglas, PS1
Foody, JM1
Gerber, TC1
Hinderliter, AL1
King, SB1
Kligfield, PD1
Krumholz, HM1
Kwong, RY1
Lim, MJ1
Linderbaum, JA1
Mack, MJ1
Munger, MA1
Prager, RL1
Sabik, JF1
Shaw, LJ1
Sikkema, JD1
Smith, CR1
Smith, SC1
Spertus, JA1
Williams, SV1
Nakai, K1
Takenobu, Y1
Takimizu, H1
Akimaru, S1
Maegawa, H1
Ito, H1
Marsala, M1
Katsube, N1
Fernández-Ortiz, A1
Bernardo, E1
Barrera Ramírez, C1
Sabaté, M1
Fernandez, C1
Hernández-Antolín, R1
Escaned, J1
Alfonso, F1
Macaya, C1
Patel, MR1
Peterson, ED1
Payne, DA1
Jones, CI1
Hayes, PD1
Naylor, AR1
Goodall, AH1
Hirano, T1
Yamori, Y1
Kanai, N1
Umetsu, T1
Nishio, S1

Clinical Trials (7)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight Aspirin-Treated Subjects With Stable Coronary Artery Disease[NCT01107925]Phase 172 participants (Actual)Interventional2010-03-31Completed
Comparative Study of Clinical Efficacy and Safety of Different Clopidogrel Salts in Patients With Cardiovascular Disease. A Multi-center Non-interventional Clinical Trial.[NCT02126982]1,500 participants (Actual)Observational2012-10-31Completed
Reversal of the Anti-platelet Effects of Ticagrelor in Healthy Persons and Patients With Coronary Artery Disease[NCT02383771]Phase 464 participants (Actual)Interventional2015-03-31Completed
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed[NCT00699998]Phase 39,326 participants (Actual)Interventional2008-06-30Completed
Laboratory Implications of Non Obstructive Atherosclerotic Plaques Identified by Multiple Detector Coronary Angiotomography[NCT03632785]90 participants (Actual)Observational2017-03-27Completed
Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline[NCT03067402]1,100 participants (Anticipated)Interventional2017-03-20Not yet recruiting
Register of Cardiovascular Complications Among People Living With HIV[NCT02453919]800 participants (Anticipated)Observational [Patient Registry]2010-02-28Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)

A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances. (NCT01107925)
Timeframe: baseline (pre-dose) up to 4 hours post-dose

Interventionnanogram•hour/milliliter (ng•hr/mL) (Geometric Mean)
Prasugrel 5 mg (LBW)28.9
Prasugrel 10 mg (LBW)59.3
Clopidogrel 75 mg (LBW)18.4
Prasugrel 5 mg (HBW)19.4
Prasugrel 10 mg (HBW)46.7
Clopidogrel 75 mg (HBW)12.7

Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy

MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition. (NCT01107925)
Timeframe: Baseline , Day 12

,,,,,
Interventionpercent aggregation (Mean)
BaselineDay 12 ( n= 32,32,31,35,37,35)
10 mg Prasugrel (HBW)77.9347.92
10 mg Prasugrel (LBW)76.2038.11
5 mg Prasugrel (HBW)77.6361.90
5 mg Prasugrel (LBW)76.2748.10
75 mg Clopidogrel (HBW)77.6365.28
75 mg Clopidogrel (LBW)76.2051.41

Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)

MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition. (NCT01107925)
Timeframe: Baseline, Day 12

,
Interventionpercent aggregation (Median)
BaselineDay 12 (n=32, 37)
Prasugrel 10 mg (HBW)76.4047.00
Prasugrel 5 mg (LBW)75.0047.00

Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy

VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition. (NCT01107925)
Timeframe: Baseline, Day 12

,,,,,
Interventionpercentage PRI (Mean)
BaselineDay 12 (n=32,31,30,32,36,34)
10 mg Prasugrel (HBW)86.7627.79
10 mg Prasugrel (LBW)86.4415.09
5 mg Prasugrel (HBW)86.7756.87
5 mg Prasugrel (LBW)86.5733.54
75 mg Clopidogrel (HBW)86.7756.35
75 mg Clopidogrel (LBW)86.4439.01

Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy

The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation. (NCT01107925)
Timeframe: Baseline, Day 12

,,,,,
InterventionP2Y12 reaction units (PRU) (Mean)
BaselineDay 12 (n=32,31,32,35,34,34)
10 mg Prasugrel (HBW)311.0102.1
10 mg Prasugrel (LBW)315.355.9
5 mg Prasugrel (HBW)312.8193.9
5 mg Prasugrel (LBW)317.9129.5
75 mg Clopidogrel (HBW)312.8207.0
75 mg Clopidogrel (LBW)315.3151.7

Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke

The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age10.61
Prasugrel: 75 Years of Age or Older27.04
Clopidogrel: <75 Years of Age11.12
Clopidogrel: 75 Years of Age or Older26.83

Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke

The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age10.06
Prasugrel: 75 Years of Age or Older24.64
Clopidogrel: <75 Years of Age10.96
Clopidogrel: 75 Years of Age or Older24.13

Percentage of Participants With a Composite Endpoint of CV Death and MI

The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age9.61
Prasugrel: 75 Years of Age or Older22.53
Clopidogrel: <75 Years of Age10.21
Clopidogrel: 75 Years of Age or Older22.69

Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)

The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

Interventionpercentage of participants with an event (Number)
Prasugrel: <75 Years of Age12.13
Prasugrel: 75 Years of Age or Older26.27
Clopidogrel: <75 Years of Age12.83
Clopidogrel: 75 Years of Age or Older25.67

Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)

Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. (NCT00699998)
Timeframe: Day 30 and 6 Months

,,,
Interventionpicograms per milliliter (pg/mL) (Geometric Mean)
Day 306 Months (n=725, 125, 701, 174)
Clopidogrel: <75 Years of Age319.345250.982
Clopidogrel: 75 Years of Age or Older951.359722.750
Prasugrel: <75 Years of Age313.494253.434
Prasugrel: 75 Years of Age or Older1082.396770.132

Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)

C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. (NCT00699998)
Timeframe: Day 30 and Month 6

,,,
Interventionmilligrams per liter (mg/L) (Geometric Mean)
Day 306 Months (n=755, 143, 745, 178)
Clopidogrel: <75 Years of Age2.2872.149
Clopidogrel: 75 Years of Age or Older2.2261.543
Prasugrel: <75 Years of Age2.3302.272
Prasugrel: 75 Years of Age or Older2.4411.593

Economic and Quality of Life Outcomes

Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life. (NCT00699998)
Timeframe: Baseline and follow-up (24 months)

,
Interventionunits on a scale (Mean)
Baseline, physical limitationsBaseline, angina frequency24 Months, physical limitations (n=420, 412)24 Months, angina frequency (n=420, 412)
Clopidogrel67.073.174.589.5
Prasugrel67.873.675.189.7

Genotyping Related to Drug Metabolism

Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100. (NCT00699998)
Timeframe: Baseline

,,,
Interventionpercentage participants with geneotype (Number)
UM, *1/*17UM, *17/*17EM (non-UM), *1/*1IM, *1/*2IM, *1/*3IM, *1/*4IM, *1/*6IM, *1/*8PM, *2/*2PM, *2/*3PM, *2/*4PM, *2/*6PM, *2/*8PM, *3/*3UNK, *1/*10UNK, *1/*13UNK, *1/*9UNK, *1/*9, *9/*17UNK, *13/*17UNK, *2/*13UNK, *2/*17UNK, *2/*9UNK, *3/*17UNK, *4/*17UNK, *4/*9UNK, *6/*17UNK, *8/*17UNK, *9/*17UNK, Undefined genotype
Clopidogrel: <75 Years of Age25.15.435.719.80.50.10.00.44.30.30.20.00.00.20.10.00.00.00.00.06.80.10.00.20.00.00.10.00.5
Clopidogrel: 75 Years of Age or Older21.84.341.219.70.60.30.20.33.80.30.20.00.00.00.00.00.00.00.00.06.20.00.30.00.00.20.00.00.6
Prasugrel: <75 Years of Age24.05.138.818.60.80.40.00.13.90.30.00.00.00.00.00.00.10.00.00.06.30.00.10.20.00.00.20.00.7
Prasugrel: 75 Years of Age or Older25.03.642.118.30.60.00.20.52.20.20.20.00.00.00.00.20.20.00.00.06.10.00.00.20.00.00.00.00.6

Platelet Aggregation Measures

Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization. (NCT00699998)
Timeframe: Day 30 and 12 Months

,,,
InterventionP2Y12 Reaction Units (PRU) (Least Squares Mean)
Day 30Month 12 (n=386, 76, 400, 103)
Clopidogrel: <75 Years of Age193.489199.003
Clopidogrel: 75 Years of Age or Older200.285181.360
Prasugrel: <75 Years of Age93.28094.529
Prasugrel: 75 Years of Age or Older151.872135.096

Summary of All Deaths

All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module. (NCT00699998)
Timeframe: Randomization through end of study (30-month visit)

,,,
Interventionparticipants (Number)
Congestive Heart FailureCardiogenic ShockCardiac RuptureMyocardial InfarctionDysrhythmiaStent ThrombosisDirectly Related to Revascularization-CABG or PCIIntracranial HemorrhageNon-Hemorrhagic StrokeSudden death due to cardiovascular eventPulmonary EmbolismStroke, unknown typeOther Cardiovascular EventCardiovascular event, unknown typeAccidentalTraumaHemorrhage, not intracranialInfectionMalignancySuicideOther Non-Cardiovascular eventCause unknown (nonadjudicated event)
Clopidogrel: <75 Years of Age13100246014470200451001614080
Clopidogrel: 75 Years of Age or Older2390213011343101451141711060
Prasugrel: <75 Years of Age1080165012475006401211414180
Prasugrel: 75 Years of Age or Older214124201143911141031217041

Reviews

2 reviews available for ticlopidine and Body Weight

ArticleYear
Management of acute coronary syndrome in the hospital: a focus on ACCF/AHA guideline updates to oral antiplatelet therapy.
    Hospital practice (1995), 2014, Volume: 42, Issue:3

    Topics: Acute Coronary Syndrome; Adenosine; Age Factors; Aspirin; Body Weight; Clopidogrel; Humans; Myocardi

2014
Recent developments in clopidogrel pharmacology and their relation to clinical outcomes.
    Expert opinion on drug metabolism & toxicology, 2009, Volume: 5, Issue:8

    Topics: Animals; Body Weight; Cardiovascular Diseases; Clopidogrel; Cytochrome P-450 Enzyme System; Humans;

2009
Recent developments in clopidogrel pharmacology and their relation to clinical outcomes.
    Expert opinion on drug metabolism & toxicology, 2009, Volume: 5, Issue:8

    Topics: Animals; Body Weight; Cardiovascular Diseases; Clopidogrel; Cytochrome P-450 Enzyme System; Humans;

2009
Recent developments in clopidogrel pharmacology and their relation to clinical outcomes.
    Expert opinion on drug metabolism & toxicology, 2009, Volume: 5, Issue:8

    Topics: Animals; Body Weight; Cardiovascular Diseases; Clopidogrel; Cytochrome P-450 Enzyme System; Humans;

2009
Recent developments in clopidogrel pharmacology and their relation to clinical outcomes.
    Expert opinion on drug metabolism & toxicology, 2009, Volume: 5, Issue:8

    Topics: Animals; Body Weight; Cardiovascular Diseases; Clopidogrel; Cytochrome P-450 Enzyme System; Humans;

2009

Trials

6 trials available for ticlopidine and Body Weight

ArticleYear
Higher body weight patients on clopidogrel maintenance therapy have lower active metabolite concentrations, lower levels of platelet inhibition, and higher rates of poor responders than low body weight patients.
    Journal of thrombosis and thrombolysis, 2014, Volume: 38, Issue:2

    Topics: Adolescent; Adult; Aged; Blood Platelets; Body Weight; Clopidogrel; Female; Humans; Male; Middle Age

2014
Smoking behaviour modulates pharmacokinetics of orally administered clopidogrel.
    Journal of clinical pharmacy and therapeutics, 2008, Volume: 33, Issue:4

    Topics: Administration, Oral; Adult; Area Under Curve; Body Weight; Clopidogrel; Drug Interactions; Half-Lif

2008
Predicting the risk of symptomatic intracerebral hemorrhage in ischemic stroke treated with intravenous alteplase: safe Implementation of Treatments in Stroke (SITS) symptomatic intracerebral hemorrhage risk score.
    Stroke, 2012, Volume: 43, Issue:6

    Topics: Age Factors; Aged; Aspirin; Body Weight; Brain Ischemia; Cerebral Hemorrhage; Clopidogrel; Female; F

2012
Clopidogrel two doses comparative 1-year assessment of safety and efficacy (COMPASS) study in Japanese patients with ischemic stroke.
    Cerebrovascular diseases (Basel, Switzerland), 2012, Volume: 34, Issue:3

    Topics: Age Factors; Aged; Asian People; Body Weight; Clopidogrel; Dose-Response Relationship, Drug; Double-

2012
Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy.
    JAMA, 2012, Nov-07, Volume: 308, Issue:17

    Topics: Acute Coronary Syndrome; Age Factors; Aged; Angina, Unstable; Aspirin; Body Weight; Clopidogrel; Fem

2012
Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy.
    JAMA, 2012, Nov-07, Volume: 308, Issue:17

    Topics: Acute Coronary Syndrome; Age Factors; Aged; Angina, Unstable; Aspirin; Body Weight; Clopidogrel; Fem

2012
Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy.
    JAMA, 2012, Nov-07, Volume: 308, Issue:17

    Topics: Acute Coronary Syndrome; Age Factors; Aged; Angina, Unstable; Aspirin; Body Weight; Clopidogrel; Fem

2012
Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy.
    JAMA, 2012, Nov-07, Volume: 308, Issue:17

    Topics: Acute Coronary Syndrome; Age Factors; Aged; Angina, Unstable; Aspirin; Body Weight; Clopidogrel; Fem

2012
Therapeutic benefit of low-dose clopidogrel in patients undergoing carotid surgery is linked to variability in the platelet adenosine diphosphate response and patients' weight.
    Stroke, 2007, Volume: 38, Issue:9

    Topics: Adenosine Diphosphate; Aspirin; Blood Platelets; Body Weight; Clopidogrel; Endarterectomy, Carotid;

2007

Other Studies

14 other studies available for ticlopidine and Body Weight

ArticleYear
Effect of body weight on bleeding events of aspirin in ischemic stroke or transient ischemic attack patients.
    Journal of clinical pharmacy and therapeutics, 2022, Volume: 47, Issue:10

    Topics: Aspirin; Body Weight; Clopidogrel; Drug Therapy, Combination; Hemorrhage; Humans; Ischemic Attack, T

2022
The influence of body size on the pharmacodynamic and pharmacokinetic response to clopidogrel and prasugrel: a retrospective analysis of the FEATHER study.
    Thrombosis research, 2014, Volume: 134, Issue:3

    Topics: Adult; Aged; Biomarkers; Blood Platelets; Body Mass Index; Body Size; Body Surface Area; Body Weight

2014
Platelet reactivity after administration of third generation P2Y12-antagonists does not depend on body weight in contrast to clopidogrel.
    Journal of thrombosis and thrombolysis, 2016, Volume: 42, Issue:1

    Topics: Adenosine; Body Weight; Clopidogrel; Dose-Response Relationship, Drug; Drug Dosage Calculations; Hum

2016
Factors associated with bleeding in elderly hospitalized patients treated with enoxaparin sodium : a prospective, open-label, observational study.
    Drugs & aging, 2009, Volume: 26, Issue:1

    Topics: Aged; Aged, 80 and over; Anticoagulants; Body Weight; Clopidogrel; Creatinine; Dose-Response Relatio

2009
CYP2C19*2 polymorphism is not the sole determinant of the response to clopidogrel: implications for its monitoring.
    Journal of thrombosis and haemostasis : JTH, 2009, Volume: 7, Issue:10

    Topics: Aged; Aryl Hydrocarbon Hydroxylases; Body Weight; Clopidogrel; Comorbidity; Cytochrome P-450 CYP2C19

2009
Beneficial effect of anti-platelet therapies on atherosclerotic lesion formation assessed by phase-contrast X-ray CT imaging.
    The international journal of cardiovascular imaging, 2012, Volume: 28, Issue:5

    Topics: Animals; Aorta; Apolipoproteins E; Atherosclerosis; Body Weight; Brachiocephalic Trunk; Cell Adhesio

2012
Body weight: a risk factor for subtherapeutic antithrombotic therapy in neurovascular stenting.
    Journal of neurointerventional surgery, 2011, Volume: 3, Issue:2

    Topics: Aspirin; Body Mass Index; Body Weight; Carotid Stenosis; Cerebrovascular Disorders; Clopidogrel; Fem

2011
The extent of P2Y12 inhibition by clopidogrel in diabetes mellitus patients with acute coronary syndrome is not related to glycaemic control: roles of white blood cell count and body weight.
    Thrombosis and haemostasis, 2012, Volume: 108, Issue:2

    Topics: Acute Coronary Syndrome; Aged; Body Weight; Clopidogrel; Diabetes Complications; Diabetes Mellitus;

2012
Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients: results from the FEATHER trial.
    Journal of the American College of Cardiology, 2012, Nov-13, Volume: 60, Issue:20

    Topics: Adolescent; Adult; Aged; Blood Platelets; Body Weight; Clopidogrel; Coronary Artery Disease; Cross-O

2012
2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the
    Journal of the American College of Cardiology, 2012, Dec-18, Volume: 60, Issue:24

    Topics: Acute Coronary Syndrome; Adrenergic beta-Antagonists; Alcohol Drinking; Angina Pectoris; Body Weight

2012
2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the
    Journal of the American College of Cardiology, 2012, Dec-18, Volume: 60, Issue:24

    Topics: Acute Coronary Syndrome; Adrenergic beta-Antagonists; Alcohol Drinking; Angina Pectoris; Body Weight

2012
2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the
    Journal of the American College of Cardiology, 2012, Dec-18, Volume: 60, Issue:24

    Topics: Acute Coronary Syndrome; Adrenergic beta-Antagonists; Alcohol Drinking; Angina Pectoris; Body Weight

2012
2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the
    Journal of the American College of Cardiology, 2012, Dec-18, Volume: 60, Issue:24

    Topics: Acute Coronary Syndrome; Adrenergic beta-Antagonists; Alcohol Drinking; Angina Pectoris; Body Weight

2012
Effects of OP-1206 alpha-CD on walking dysfunction in the rat neuropathic intermittent claudication model: comparison with nifedipine, ticlopidine and cilostazol.
    Prostaglandins & other lipid mediators, 2003, Volume: 71, Issue:3-4

    Topics: Alprostadil; Animals; Body Weight; Cilostazol; Disease Models, Animal; Exercise Test; Intermittent C

2003
Platelet aggregation according to body mass index in patients undergoing coronary stenting: should clopidogrel loading-dose be weight adjusted?
    The Journal of invasive cardiology, 2004, Volume: 16, Issue:4

    Topics: Aged; Blood Vessel Prosthesis Implantation; Body Mass Index; Body Weight; Clopidogrel; Coronary Sten

2004
Clopidogrel dosing in overweight patients: does one size fit all?
    The Journal of invasive cardiology, 2004, Volume: 16, Issue:4

    Topics: Blood Vessel Prosthesis Implantation; Body Mass Index; Body Weight; Clopidogrel; Coronary Stenosis;

2004
The effects of beraprost Na, a stable prostacyclin analog, on animal models of stroke.
    Molecular and chemical neuropathology, 1992, Volume: 17, Issue:1

    Topics: Animals; Arachidonic Acid; Blood Pressure; Body Weight; Cerebrovascular Circulation; Cerebrovascular

1992