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
  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:


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

ClinicalTrials.gov processed this record on October 21, 2014