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Aspirin Resistance Following Coronary Bypass Surgery

This study has been terminated.
(The researcher had left the hospital and the project was stopped)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00260377
First Posted: December 1, 2005
Last Update Posted: September 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
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 Intervention
Ischemic Heart Disease Procedure: Coronary artery bypass surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Ventilation
  • Inotropic support
  • Mortality
  • Perioperative MI
  • Perioperative stroke
  • Bleeding / reopen / transfusion
  • Dysrhythmias

Secondary Outcome Measures:
  • ICU stay
  • In-hospital stay
  • Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias
  • Need for repeat revascularization

Study Start Date: January 2005
Estimated Study Completion Date: December 2006
Estimated Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00260377     History of Changes
Other Study ID Numbers: SHEBA-03-3107-JL-CTIL
First Submitted: November 29, 2005
First Posted: December 1, 2005
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