A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel (LY640315) versus Clopidogrel in Subjects with Stable Atherosclerosis - TABR

Eli Lilly and Company Ltd.0 sites110 target enrollmentJanuary 18, 2006

Overview

No summary available.

Registry

who.int

Start Date

January 18, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Eli Lilly and Company Ltd.

•1\.Male or female subjects with a history of stable coronary artery disease in whom co\-administration of aspirin and a thienopyridine (i.e., clopidogrel or ticlopidine) is not contraindicated.
•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 revascularization 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.
•2\.Subjects between the ages of 40 and 75 years (inclusive) with a competent mental condition to provide written informed consent before entering the study. Subjects must provide written informed consent approved by Eli Lilly and Company and the Ethical Review Board governing each site.
•3\.Women who are not of child\-bearing potential; in other words, either post\-menopausal and/or surgical sterilization (including tubal ligation). Post menopausal females are defined as at least 2 years post cessation of menses.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•Cardiovascular Exclusion Criteria
•1\.Subjects with unstable coronary artery disease, defined as any of the following observed at screening: new, increased, or rest angina; hospitalization for unstable angina within the previous 30 days; diagnosis of MI within previous 30 days; PCI within previous 90 days; or CABG within previous 90 days.
•2\.Subjects with a history of refractory ventricular arrhythmias.
•3\.Subjects with a history of an implantable defibrillator device.
•4\.Subjects with a history or evidence of congestive heart failure (NYHA Class III or above) within 6 months prior to screening.
•5\.Subjects with significant hypertension (systolic blood pressure \>180 or diastolic blood pressure \>110 mmHg) at the time of screening or randomization.
•6\.Any coronary revascularization (surgical or percutaneous) performed within 3 months prior to randomization.
•7\.Any coronary revascularization (surgical or percutaneous) planned within 40 days following randomization.
•Bleeding Risk Exclusion Criteria
•8\.Any known contraindication to treatment with an anticoagulant or antiplatelet agent.