A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Arteriosclerosis; Acute Coronary Syndrome
Intervention: Prasugrel (Drug); Clopidogrel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Evaluate the incidence of major and minor bleeding events in subjects receiving CS-747 or Clopidogrel and overall safety and tolerability of CS-747
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
For more information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Global Quintiles Study Line (1-866-615-4672) or speak with your physician, Indianapolis, Indiana, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: November 2004
Ending date: July 2007
Last updated: November 5, 2007
|
