NCT00260377

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 9, 2008

Status Verified

September 1, 2008

Enrollment Period

1.4 years

First QC Date

November 29, 2005

Last Update Submit

September 8, 2008

Conditions

Ischemic Heart Disease

Keywords

Aspirin treatmentAspirin resistanceCoronary bypass surgery

Outcome Measures

Primary Outcomes (7)

  • Ventilation

  • Inotropic support

  • Mortality

  • Perioperative MI

  • Perioperative stroke

  • Bleeding / reopen / transfusion

  • Dysrhythmias

Secondary Outcomes (4)

  • ICU stay

  • In-hospital stay

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

  • Need for repeat revascularization

Interventions

Coronary artery bypass surgeryPROCEDURE

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Jacob Lavee, Dr

    jacob.lavee@sheba.health.gov.il

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2006

Study Completion

December 1, 2006

Last Updated

September 9, 2008

Record last verified: 2008-09

Locations

IL(1)