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

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

Participants will include both male and female subjects with stable coronary artery disease (CAD) who are at least 18 years of age and less than 75 years of age (with subjects grouped by body weight, either <60 kg or >=60 kg), and who are not currently indicated for treatment with a thienopyridine. Stable coronary artery disease is defined as any of the following: Subjects diagnosed with chronic stable angina; prior history of unstable angina (including non-ST-segment elevation myocardial infarction) or acute myocardial infarction (AMI); previous coronary revascularisation including percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or CAD in at least one coronary vessel on previous angiography or noninvasive imaging procedure.

Exclusion Criteria

Criteria for exclusion include (but not limited to):
• Unstable coronary artery disease.
• PCI or CABG within the previous 90 days.
• History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
• Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation.
• Any known contraindication to treatment with an antiplatelet agent.
• Significant hypertension at the time of screening or randomisation.
• Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator*s opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator.
• Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders.
• Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, transient ischaemic attack (TIA), or stroke.
• Prior history or presence of thrombocytopaenia or thrombocytosis.
• Use of antiplatelet agents (excluding aspirin) *10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Criteria for Evaluation:<br /><br>Efficacy: No efficacy measures will be collected in this study.<br /><br>Safety: Laboratory measures, adverse events.<br /><br>Pharmacokinetic: Blood samples will be collected for the determination of<br /><br>plasma concentrations of the prasugrel active metabolite (R-138727), prasugrel<br /><br>inactive metabolites (R-95913, R-106583, and R-119251), and the clopidogrel<br /><br>active metabolite (R-130964). Inactive metabolites of clopidogrel will not be<br /><br>analysed in this study.<br /><br>Pharmacodynamic: LTA (ADP); VerifyNow® P2Y12; Vasodilator-associated<br /><br>stimulated phosphoprotein (VASP). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>

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