Status:
UNKNOWN
Time Based Strategy to Reduce Clopidogrel Associated Bleeding Related to Coronary Artery Bypass Graft (CABG)
Lead Sponsor:
LifeBridge Health
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Purpose: In patients with coronary artery disease, aspirin and Plavix are used increasingly to prevent the formation of blood clots in the coronary arteries. These drugs exert their beneficial effects...
Detailed Description
Primary objective: We hypothesize that stratifying patients on clopidogrel into time-based platelet function recovery groups as determined by pre-operative clopidogrel response measured by point of c...
Eligibility Criteria
Inclusion
- Patients must provide written informed consent.
- Patients must currently be on aspirin therapy (81-325 mg).
- Male or female patients between the ages of 18-85 requiring CABG.
Exclusion
- Patients undergoing emergent surgery following failed percutaneous coronary revascularization.
- Patients with a history of previous cardiac surgery and patients needing concomitant valvular surgery.
- Pre-operative exposure to either coumadin or platelet GPIIb/IIIa inhibitors.
- Patients with a history of bleeding diathesis.
- Patients with an activated partial thrombin time \>1.5 normal.
- Patients with platelet count \<120,000/mm3.
- Patients with hematocrit \<30%.
- Patients with creatinine clearance \<30mL/min.
- Patients with known active hepatic disease.
- Patients with any other condition that, in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g. malignancy, limiting life expectancy, noncompliance).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00857155
Start Date
January 1 2009
End Date
February 1 2011
Last Update
March 6 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sinai Hospital
Baltimore, Maryland, United States, 21215