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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:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00260377
First received: November 29, 2005
Last updated: September 8, 2008
Last verified: September 2008
History of Changes
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00260377     History of Changes
Other Study ID Numbers: SHEBA-03-3107-JL-CTIL
Study First Received: November 29, 2005
Last Updated: September 8, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013