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

Lilly

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: Clopidogrel; Drug: Prasugrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385944

10632

H7T-MC-TABN (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Prasugrel

Experimental group

Description:

Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of clopidogrel two 75 mg tablets and one placebo matched to prasugrel and 100 mg aspirin, all taken orally once a day for the next 14 days.

Treatment:

Drug: Prasugrel

Clopidogrel

Active Comparator group

Description:

Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) Clopidogrel two 75 mg and one placebo tablet, matched to prasugrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of prasugrel one 10 mg tablet and two placebo tablets matched to clopidogrel and 100 mg aspirin, all taken orally once a day for the next 14 days.

Treatment:

Drug: Clopidogrel