Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate how platelets recover to normal function in subjects who have symptoms of a heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for planned coronary angiography.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Daiichi Sankyo Co., Ltd.
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

• Men or women ≥18 to <80 years of age who present with any one of the following:

• symptoms of Acute Coronary Syndromes (ACS)

• clinical symptoms of angina, or a positive stress test or who return for routine follow up angiography post stent placement in whom co-administration of aspirin and a thienopyridine (that is, clopidogrel, ticlopidine, or prasugrel) is not contraindicated

Exclusion Criteria:

• Those presenting with ST-elevation MI (STEMI)

• histories of refractory ventricular arrhythmias

• an implanted defibrillator device

• congestive heart failure (NYHA Class III or above) within 6 months prior to screening

• significant hypertension

• subjects with a history or clinical suspicion of cerebral vascular malformations, transient ischaemic attack, or stroke

• bleeding disorders

• women known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding