The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass

December 30, 2010 updated by: Chinese Academy of Medical Sciences, Fuwai Hospital
Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital
        • Contact:
        • Principal Investigator:
          • Hansong Sun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective, off-pump coronary artery bypass with at least two grafts
  • patient able to give informed consent

Exclusion Criteria:

  • on-pump CABG
  • combined with the valve surgery
  • Preoperative use of clopidogrel and warfarin
  • allergy to aspirin
  • History of severe liver disease
  • History of bleeding diathesis,significant GI bleed
  • Patient has known renal failure or contraindication for Cardiac CT Angio
  • Redo CABG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preoperative aspirin use
Drug: aspirin
aspirin 100mg daily until the surgery day
Drug: aspirin
aspirin is stopped 5-7 days before operation
No Intervention: preoperative aspirin nonuse
Drug: aspirin
aspirin 100mg daily until the surgery day
Drug: aspirin
aspirin is stopped 5-7 days before operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
graft patency examined by CT scan
Time Frame: one week after surgery
we would like to compare the graft patency within the one week after the surgery between the preoperative aspirin use and preoperative nonuse.We just want to know wether preoperative aspirin use could improve the graft patency in off-pump coronary artery bypass.
one week after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding, transfusion, re-exploration
Time Frame: perioperative
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

December 29, 2010

First Submitted That Met QC Criteria

December 30, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

December 31, 2010

Last Update Submitted That Met QC Criteria

December 30, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fuwai Hospital 2010-259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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