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

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

Sponsors

Lead sponsor: Eli Lilly and Company

Collaborator: Daiichi Sankyo, Inc.

Source Eli Lilly and Company
Brief Summary

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.

Overall Status Completed
Start Date November 2004
Completion Date July 2007
Primary Completion Date July 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke Randomization up to 15 months
Secondary Outcome
Measure Time Frame
Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events First dose of study drug up to 15 months (while at risk)
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR) Randomization to 30 days; randomization to 90 days
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke Randomization to 30 days; randomization to 90 days
Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events Randomization up to 15 months
Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke Randomization up to 15 months
Enrollment 13619
Condition
Intervention

Intervention type: Drug

Intervention name: Prasugrel

Description: Administered orally

Arm group label: Prasugrel

Intervention type: Drug

Intervention name: Clopidogrel

Description: Administered orally

Arm group label: Clopidogrel

Eligibility

Criteria:

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
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 Eli Lilly and Company
Location
facility 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
Location Countries

United States

Verification Date

August 2010

Responsible Party

Name title: Chief Medical Officer

Organization: Eli LIlly

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Prasugrel

Arm group type: Experimental

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

Arm group label: Clopidogrel

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov