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Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding in Coronary Surgical Patients

NCT01216150 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2011-06-23

No results posted yet for this study

Summary

Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary syndromes. Although the maintenance of aspirin until surgery does not affect postoperative bleeding after coronary artery bypass graft (CABG) surgery, the latter may be dramatically increased when clopidogrel is continued over a period of 5 days preoperatively. Methods and results: This prospective observational study will include 136 consecutive patients scheduled for first-time CABG. Postoperative bleeding and blood transfusion requirements will be compared (non inferiority)between patients pretreated during a period of 5 days prior surgery by either aspirin alone or combined with clopidogrel. Tranexamic acid will be systematically used in all these patients considered as high risk for bleeding.

In concusion, this study has to to test the hypothesis that with tranexamic acid also, bleeding in the aspirin + clopidogrel group is not 25% more important than in the aspirin alone group after CABG surgery, according to the previous study using aprotinin.

Conditions

Sponsors & Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Principal Investigators

  • Julien Amour, MD.PhD · Groupe Hospitalier Pitie-Salpetriere

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216150 on ClinicalTrials.gov