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

• Conditions: Stable atherosclerosis; MedDRA version: 7.0Level: HLTClassification code 10011085

• Registration Number: EUCTR2005-005292-15-SE
• Lead Sponsor: Eli Lilly and Company Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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.
9.Prior history or presence of significant bleeding disorders (for example, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding).
10.Prior history or clinical suspicion of cerebral vascular malformations, for example, prior history of cerebral hemorrhage, aneurysm or premature stroke (CVA <65 years of age).
11.Prior history of abnormal bleeding tendency (i.e. prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure).
12.Personal or family history of coagulation or bleeding disorders.
13.Prior history of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (platelet count > 500,000/mm3).
14.Clinically significant out of range values for PT, aPTT, platelet count or hemoglobin at screening, in the investigator’s opinion.
15.History of major surgery, severe trauma, fracture or organ biopsy within 3 months prior to enrollment.
16.Any planned surgical procedure within 40 days following randomization.
Prior/Concomitant Therapy Exclusion Criteria
17.Subjects taking ticlopidine or clopidogrel less than or equal 10 days prior to screening.
18.The use (or planned use) of antiplatelet agents (besides aspirin), heparin, warfarin or fibrinolytic agents within 30 days of screening.
19.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.
General Exclusion Criteria
20.Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
21.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.
22.Subjects who are unreliable and unwilling to make themselves available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions.
23.Subjects enrolled in either another investigational drug study, in another investigational device study, or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
24.Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel, prasugrel or ticlopidine).
25.Evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator’s opi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified