A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Brief Summary

The sponsors of this investigational drug are developing prasugrel 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 will be compared with clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Test the hypothesis that CS-747 plus aspirin is superior to clopidogrel plus aspirin in the treatment of subjects with acute coronary syndrome who are to undergo percutaneous coronary intervention (PCI),
as measured by a reduction in the composite endpoint of cardiovascular (CV) death,nonfatal myocardial infarction (MI), or nonfatal stroke at a median follow-up of at least 12 months

Secondary Outcome Measure ^†

Evaluate the incidence of major and minor bleeding events in subjects receiving CS-747 or Clopidogrel and overall safety and tolerability of CS-747

Condition ^†

Coronary Arteriosclerosis
Acute Coronary Syndrome

Intervention ^†

Drug: Prasugrel
Drug: Clopidogrel

MEDLINE PMIDs

Links

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

13000

Start Date ^†

November 2004

Completion Date

July 2007

Eligibility Criteria ^†

Inclusion Criteria:

A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous 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 a stroke within the last 3 months.
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.
A person who has liver disease; for example, cirrhosis.
A person who has a condition such as alcoholism, mental illness, or is drug dependent.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00097591

Organization ID

8695

Secondary IDs ^††

H7T-MC-TAAL

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Investigators ^†

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

First Received Date ^†

November 24, 2004

Last Updated Date

November 5, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.