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

This study has been completed.

First Received: October 6, 2006 Last Updated: December 3, 2007 History of Changes

Sponsors and Collaborators:	Eli Lilly and Company Daiichi Sankyo Inc.
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00385944

Purpose

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 of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose of clopidogrel.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Prasugrel Drug: Clopidogrel	Phase II

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Cross-Over Study Comparing the Pharmacodynamic Response in Subjects With Acute Coronary Syndrome Receiving 14 Days 10-mg MD Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg LD of Clopidogrel to Reduce Ongoing Platelet Activation

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Establish an advantage of prasugrel compared with clopidogrel as assessed by mean MPA at the end of the specified treatment periods in subjects with ACS.

Secondary Outcome Measures:

Assess prasugrel & clopidogrel maintenance doses to ADP by MPA; Assess prasugrel & clopidogrel maintenance dose to varying amounts of ADP by IPA.

Estimated Enrollment:	70
Study Start Date:	March 2007
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel.
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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385944

Locations

France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Creteil, France, 94010
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris, France, 75013

Sponsors and Collaborators

Eli Lilly and Company

Daiichi Sankyo Inc.

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

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	10632, H7T-MC-TABN
Study First Received:	October 6, 2006
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00385944 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Clopidogrel
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Platelet Aggregation Inhibitors
Ischemia

Additional relevant MeSH terms:

Disease
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Pharmacologic Actions
Pathologic Processes

Syndrome
Clopidogrel
Therapeutic Uses
Acute Coronary Syndrome
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 06, 2009