A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

Lilly

Status and phase: Completed; Phase 3

Conditions: Coronary Arteriosclerosis; Acute Coronary Syndromes

Treatments: Drug: Prasugrel; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097591

H7T-MC-TAAL (Other Identifier)

8695

Details and patient eligibility

About

The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Enrollment: 13,619 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.
• A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
• If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion criteria

• A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
• A person who has active internal bleeding or has a history of a bleeding disorder.
• Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
• A person who has liver disease; for example, cirrhosis.
• A person who has a condition such as alcoholism, mental illness, or is drug dependent.
• A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13,619 participants in 2 patient groups

Prasugrel

Experimental group

Description:

Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily

Treatment:

Drug: Prasugrel

Clopidogrel

Active Comparator group

Description:

Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily

Treatment:

Drug: Clopidogrel