Skip to main content
OpenTrials
Completed

NCT Number: NCT00724880

Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery.

* 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 grafting. Is surgical delay necessary in patients using clopidogrel? And if so, which is the safety time interval when clopidogrel should be stopped before surgery in order to avoid bleeding and other related complications. * Background: By blockade of the platelet ADP receptor, clopidogrel inhibits the binding of fibrinogen to the platelet GPIIb/IIIa receptor complex, thereby preventing platelet aggregation from ADP stimulation. Some authors suggest that the platelet function is completely recovered in 7 days after stopping clopidogrel in healthy subjects. Other researches suggest full recovery of platelet function in 3 to 5 days. * Study objectives: To investigate if the interruption of the clopidogrel is necessary before CABG in order to prevent bleeding and other complications.

To trace the increased risk patients for postoperative bleeding and to individualize the therapy according to TEG measurements.

* Design: A prospective, randomized mono- center study * Patients: Patients who are receiving elective or urgent CABG surgery and are pre-treated at least 5 days before surgery with clopidogrel * Primary endpoint: To determine if there are significant differences in blood loss, transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel To asses the predictive value of the TEG clot strength in postoperative bleeding in patients using Clopidogrel. * Secondary endpoints: Death, myocardial infarction, stroke, respiratory failure, renal failure requiring dialysis, mediastinitis,readmission rates within 30 days from discharge, and ICU and hospital lengths of stay * Risks: Using standard dose of aprotinin, we consider no increased risk in blood loss and other related complications for this three groups of patients. * Possible benefits: Reduction of time delay in operating patients under treatment with clopidogrel.

A more accurate time interval when clopidogrel should be stopped before surgery in order to eliminate the risk of bleeding and associated complications.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Clopidogrel is stopped 5 days prior to surgery

Other names: plavix

Primary outcomes

  1. The primary end point of this study is to determine if there are significant differences in blood loss, transfusions and rethoracotomies in the three selected groups of patients treated with clopidogrel

    Time frame: within 30 days (+/- 5 days) after surgery

  2. To asses the predictive value of the TEG clot strength in postoperative bleeding in patients using clopidogrel

    Time frame: within 30 days (+/- 5 days) after surgery

Secondary outcomes

  1. death

    Time frame: within 30 days (+/- 5 days) after surgery

  2. myocardial infarction

    Time frame: within 30 days (+/- 5 days) after surgery

  3. stroke

    Time frame: within 30 days (+/- 5 days) after surgery

  4. respiratory failure

    Time frame: within 30 days (+/- 5 days) after surgery

  5. renal failure requiring dialysis

    Time frame: within 30 days (+/- 5 days) after surgery

  6. mediastinitis

    Time frame: within 30 days (+/- 5 days) after surgery

  7. wound infection

    Time frame: within 30 days (+/- 5 days) after surgery

  8. readmission rates within 30 days from discharge

    Time frame: within 30 days (+/- 5 days) after surgery

  9. ICU and hospital lengths of stay.

    Time frame: within 30 days (+/- 5 days) after surgery

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

Effect of Clopidogrel (Plavix) on Postoperative Bleeding in Patients Undergoing Coronary Artery Bypass Surgery. A Prospective Randomized Controlled Study

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 30, 2008
Registry last updated
Jul 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.