Aspirin Resistance Following Coronary Bypass Surgery

Ischemic Heart Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00260377
• Other study ID #: SHEBA-03-3107-JL-CTIL
• Status: Terminated
• Phase: N/A
• First received: November 29, 2005
• Last updated: September 8, 2008
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: September 2008
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary artery bypass surgery

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilation
Primary	Inotropic support
Primary	Mortality
Primary	Perioperative MI
Primary	Perioperative stroke
Primary	Bleeding / reopen / transfusion
Primary	Dysrhythmias
Secondary	ICU stay
Secondary	In-hospital stay
Secondary	Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias
Secondary	Need for repeat revascularization