Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event (SWAP)

Lilly

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome; Coronary Arteriosclerosis

Treatments: Drug: clopidogrel; Drug: prasugrel 60 mg; Drug: clopidogrel placebo; Drug: prasugrel 10 mg; Drug: prasugrel placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356135

H7T-MC-TABM (Other Identifier)

10631

Details and patient eligibility

About

This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).

Enrollment: 139 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with a recent history of an ACS event based on the disease diagnostic criteria between 30 and 330 days prior to enrollment, and who state that they are supposed to be taking daily aspirin and maintenance dose 75-mg clopidogrel.
• Are of a legal age (and at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent before entering the study.

Exclusion criteria

• Left main coronary artery stent or left anterior descending (LAD) bifurcation stent.
• Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).
• Have undergone CABG or PCI within 30 days of entry into the study.
• Receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
• Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
• Have any of the following: history of ischemic or hemorrhagic stroke intracranial neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack (TIA), have a body weight less than 60 kilograms (kg).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

139 participants in 3 patient groups

Prasugrel 10/10 mg

Experimental group

Description:

Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.

Treatment:

Drug: clopidogrel placebo

Drug: prasugrel 10 mg

Drug: prasugrel placebo

Drug: clopidogrel

Clopidogrel 75/75 mg

Experimental group

Description:

Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.

Treatment:

Drug: prasugrel placebo

Drug: clopidogrel

Prasugrel 60/10 mg

Experimental group

Description:

Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.

Treatment:

Drug: clopidogrel placebo

Drug: prasugrel 10 mg

Drug: prasugrel 60 mg

Drug: clopidogrel