The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome
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: Acute Coronary Syndrome
Intervention: Prasugrel (Drug); Clopidogrel (Drug)
Phase: Phase 2
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
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Primary outcome: 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: Assess prasugrel & clopidogrel maintenance doses to ADP by MPA; Assess prasugrel & clopidogrel maintenance dose to varying amounts of ADP by IPA.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
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 94010, 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., Paris 75013, France
Additional Information
Lilly Clinical Trial Registry
Starting date: March 2007
Ending date: October 2007
Last updated: December 3, 2007
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