Status:
COMPLETED
Clopidogrel and Aspirin Together: The Effect on C-Reactive Protein Trial
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
Bristol-Myers Squibb
Sanofi-Synthelabo
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Inflammation is associated with worsening outcomes among individuals with CAD; C-reactive protein is a well-known marker of inflammation. Both healthy patients and those with a history of CAD who exhi...
Detailed Description
The objective of this trial is to assess the effects of combined therapy of clopidogrel and aspirin versus placebo and aspirin on CRP in patients with known CAD. Potential subjects already on stable ...
Eligibility Criteria
Inclusion
- Either gender \> 18 years of age
- Documented coronary artery disease (CAD) of\~ 70% documented lesion
- Must be taking 325 mg/day of aspirin (preferably Ecotrin)and a statin at least 4 weeks prior to enrollment
- The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board
- Able to give informed consent
Exclusion
- Documented sensitivity to aspirin or clopidogrel
- Uncontrolled hypertension as determined by the investigator
- Known bleeding disorder or increased risk of bleeding such as: severe hepatic, insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of bleeding diathesis or coagulopathy
- History of severe systemic bleeding such as: gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
- Hospitalization for any MI or unstable angina in last 90 days
- Scheduled for a major surgery requiring prolonged study drug cessation (more than 4 weeks)
- Currently taking a thienopyridine agent (clopidogrel or ticlopidine), oral GP IIb/IIIa inhibitor, oral anticoagulant, or dipyridamole
- Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00343876
Start Date
July 1 2005
End Date
November 1 2006
Last Update
August 21 2008
Active Locations (1)
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1
LDS Hospital
Salt Lake City, Utah, United States, 84143