Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding in Coronary Surgical Patients (ICARE)
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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. |
- 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.
- 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 |
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.
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 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 May 21, 2013