The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

• Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).

• Are between the ages of 18 and 85 years.

• Willing and able to sign informed consent.

Exclusion Criteria:

• Have overt ST-segment elevation myocardial infarction (STEMI).

• Have cardiogenic shock.

• Have refractory ventricular arrhythmias.

• Have New York Heart Association (NYHA) Class IV congestive heart failure.

• Have severe and uncontrolled hypertension.

• Have active internal bleeding or history of bleeding diathesis.

• Have an increased risk of bleeding.

• Have history of cerebrovascular accidents.

• Have certain abnormal blood level values.

• Are currently receiving chemotherapy or radiation therapy.