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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01268917
Recruitment Status : Unknown
Verified March 2010 by Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2010
Last Update Posted : December 31, 2010
Information provided by:
Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Off-pump Coronary Artery Bypass Aspirin Drug: aspirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2010
Estimated Primary Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: preoperative aspirin use Drug: aspirin
aspirin 100mg daily until the surgery day

No Intervention: preoperative aspirin nonuse Drug: aspirin
aspirin is stopped 5-7 days before operation

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Bleeding, transfusion, re-exploration [ Time Frame: perioperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01268917

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Fuwai Hospital Recruiting
Beijing, China, 100037
Contact: Hengchao Wu, MD    8601088398701   
Principal Investigator: Hansong Sun, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Fuwai Hospital Identifier: NCT01268917    
Other Study ID Numbers: Fuwai Hospital 2010-259
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: December 31, 2010
Last Verified: March 2010
Keywords provided by Chinese Academy of Medical Sciences, Fuwai Hospital:
coronary artery disease
off-pump coronary artery bypass
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors