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Aspirin Resistance Following Coronary Bypass Surgery

Primary Purpose

Ischemic Heart Disease

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Coronary artery bypass surgery

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Aspirin treatment, Aspirin resistance, Coronary bypass surgery

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sheba Medical Center

Outcomes

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

Full Information

NCT ID

NCT00260377

First Posted

November 29, 2005

Last Updated

September 8, 2008

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00260377

Brief Title

Aspirin Resistance Following Coronary Bypass Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Terminated

Why Stopped

The researcher had left the hospital and the project was stopped

Study Start Date

January 2005 (undefined)

Primary Completion Date

June 2006 (undefined)

Study Completion Date

December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

Aspirin treatment, Aspirin resistance, Coronary bypass surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Coronary artery bypass surgery

Primary Outcome Measure Information:

Title

Ventilation

Title

Inotropic support

Title

Mortality

Title

Perioperative MI

Title

Perioperative stroke

Title

Bleeding / reopen / transfusion

Title

Dysrhythmias

Secondary Outcome Measure Information:

Title

ICU stay

Title

In-hospital stay

Title

Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias

Title

Need for repeat revascularization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob Lavee, Dr

Organizational Affiliation

jacob.lavee@sheba.health.gov.il

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Ramat-Gan

Country

Israel

12. IPD Sharing Statement

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Aspirin Resistance Following Coronary Bypass Surgery

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