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Aspirin Resistance Following Coronary Bypass Surgery

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ClinicalTrials.gov Identifier: NCT00260377
Recruitment Status : Terminated (The researcher had left the hospital and the project was stopped)
First Posted : December 1, 2005
Last Update Posted : September 9, 2008
Sponsor:
Information provided by:
Sheba Medical Center

Brief Summary:
Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. It appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. the exact effective dose is not known.

Condition or disease Intervention/treatment
Ischemic Heart Disease Procedure: Coronary artery bypass surgery

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2005
Estimated Primary Completion Date : June 2006
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources




Primary Outcome Measures :
  1. Ventilation
  2. Inotropic support
  3. Mortality
  4. Perioperative MI
  5. Perioperative stroke
  6. Bleeding / reopen / transfusion
  7. Dysrhythmias

Secondary Outcome Measures :
  1. ICU stay
  2. In-hospital stay
  3. Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias
  4. Need for repeat revascularization


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Coronary artery bypass surgery
  • Patients who signed Informed Consent Form

Exclusion Criteria:

  • Concomitant valve surgery or carotid surgery or off-pump surgery
  • Need for anticoagulation therapy for any reason
  • Another antiplatelet medications at least 7 days prior to surgery
  • Contra-indication for aspirin treatment
  • Thrombocytopenia / thrombocytopathia
  • NSAIDs treatment for chronic medical conditions
  • Reluctance to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260377


Locations
Israel
Sheba Medical Center
Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Jacob Lavee, Dr jacob.lavee@sheba.health.gov.il

ClinicalTrials.gov Identifier: NCT00260377     History of Changes
Other Study ID Numbers: SHEBA-03-3107-JL-CTIL
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Sheba Medical Center:
Aspirin treatment
Aspirin resistance
Coronary bypass surgery

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics