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

This study has been completed.
Sponsor:
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT01216150
First received: October 6, 2010
Last updated: June 22, 2011
Last verified: October 2010
  Purpose

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.


Condition
Coronary Surgery
Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding and Platelets Functions in Coronary Surgical Patients Treated Prophylactically With Tranexamic Acid: the ICARE Study.

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • chest blood output during the first 24 hours [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    Chest blood collected through chest tubes during the first 24 postoperative hours.


Secondary Outcome Measures:
  • the rate of re-exploration for excessive bleeding, transfusion requirement, prolonged mechanical ventilation (>10 h), and intensive care unit length of stay (>72 h). [ Time Frame: During critical care unit hospitalisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
aspirin
group treated with aspirin alone
aspirin clopidogrel
Goup treated with aspirin and clopidogrel

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

During the planned 11 months of investigation, all patients undergoing isolated first-time coronary artery by-pass grafting will be enrolled. Patients admitted for emergency procedure, following failed percutaneous transluminal coronary angioplasty and off-pump coronary surgery, will be excluded. Because antithrombotic therapy management may differ during the postoperative period, we will exclude patients in whom a mechanical support or intra-aortic balloon pump will be required for a difficult weaning from cardiopulmonary bypass. Finally, we will exclude all patients who will not have received any oral antiplatelet agents within 5 days prior surgery, those who will have been preoperatively exposed to platelet glycoprotein IIb/IIIa inhibitors, and those with history of haematological disease. Patients treated with aspirin and clopidogrel and in whom clopidogrel will be stopped more than 5 days before surgery will also be excluded.

Criteria

Inclusion Criteria:

  • all patients undergoing isolated first-time coronary artery by-pass grafting will be enrolled.

Exclusion Criteria:

  • patient who do not want to be include
  • pregnant
  • patient < 18 yrs old
  • emergency procedure with failed percutaneous transluminal coronary angioplasty
  • off-pump coronary surgery
  • patients in whom a mechanical support (ECMO) or intra-aortic balloon pump will be required for a difficult weaning from cardiopulmonary bypass
  • patients who will not have received any oral antiplatelet agents within 5 days prior surgery
  • patient who will be preoperatively exposed to platelet glycoprotein IIb/IIIa inhibitors
  • Patients treated with aspirin and clopidogrel and in whom clopidogrel will be stopped more than 5 days before surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216150

Locations
France
Hopital Pitié Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Investigators
Study Director: Julien Amour, MD.PhD HOPITAL PITIE-SALPETRIERE
  More Information

No publications provided

Responsible Party: AMOUR julien, Hôpital Pitié Salpêtrière, Paris, France
ClinicalTrials.gov Identifier: NCT01216150     History of Changes
Other Study ID Numbers: ICARE Study
Study First Received: October 6, 2010
Last Updated: June 22, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
antifibrinolytic drug
coronary surgery
hemorrhage
aspirin
clopidogrel

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on August 01, 2014