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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Cardiovascular Institute & Fuwai Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01268917
First received: December 29, 2010
Last updated: December 30, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
Off-pump Coronary Artery Bypass
Aspirin
 Drug: aspirin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • graft patency examined by CT scan [ Time Frame: one week after surgery ] [ Designated as safety issue: No ]
    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:
  • Bleeding, transfusion, re-exploration [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268917

Locations
China
Fuwai Hospital Recruiting
Beijing, China, 100037
Contact: Hengchao Wu, MD     8601088398701     whcwuhengchao@163.com    
Principal Investigator: Hansong Sun, MD            
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
  More Information

No publications provided

Responsible Party: Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01268917     History of Changes
Other Study ID Numbers: Fuwai Hospital 2010-259
Study First Received: December 29, 2010
Last Updated: December 30, 2010
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
coronary artery disease
off-pump coronary artery bypass
aspirin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013