Status:
COMPLETED
Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery.
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
* Running title: Effect of Clopidogrel on Postoperative Bleeding in Patients undergoing Coronary Artery Bypass Surgery * Title: Clopidogrel and bleeding in patients undergoing coronary artery bypass g...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients who are using clopidogrel at least 5 days before surgery with a dose of 75 mg clopidogrel without loading dose with or without concomitant use of aspirin.
- Patients who received a loading dose of 300-600 mg clopidogrel 24 hours before CABG, with or without concomitant use of aspirin
- Patients approved for elective or urgent CABG surgery
- Exclusion criteria:
- Patients who are concomitant using oral coumarin derivates, heparine derivates iv., dipiridamol or other anticoagulant treatment, 5 days before operation.
- Patients with pre-existing bleeding disorders, thrombocytopenia
- Patients who have renal insufficiency (creatinine \>2.0 mg/dL) or chronic renal failure requiring dialysis
- Patients in end stage heart failure
- Patients who have evidence of significant hepatic disease including clinical signs or laboratory values of total bilirubin\> 2.0 mg/dL, ALAT or ASAT\> 3X upper limit of normal, or INR \>2X upper limit of normal (not due to anticoagulation therapy)
- Emergency bypass surgery when patients cant be random enrolled in one of the three groups
- Concomitant valvular or other cardiac procedures
- Re-operation (patients known with previous heart operations)
- Off-pump CABG
- Chronic alcoholism
- Immediate post operative complications that in the opinion of the investigator can alter the further results of the trial (thromboembolism or ischemic CVA with use of anticoagulants, severe liver function disorders, sepsis, disseminated intravascular coagulation, adverse effects to blood products, etc)
- Patients whom recently (3-6 months before screening) received PCI and continuation of clopidogrel till the day of operation is advisable (according to the advice of the cardiologist)
- Patients who refuse to accept medically- indicated blood products
- Pregnancy and breast feeding
- Patients who received investigational drugs in the previous 30 days, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00724880
Start Date
June 1 2006
End Date
December 1 2007
Last Update
July 30 2008
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