- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01268917
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
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
-
-
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Beijing, China, 100037
- Recruiting
- Fuwai Hospital
-
Contact:
- Hengchao Wu, MD
- Phone Number: 8601088398701
- Email: whcwuhengchao@163.com
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Principal Investigator:
- Hansong Sun, MD
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-
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
|
aspirin 100mg daily until the surgery day
aspirin is stopped 5-7 days before operation
|
No Intervention: preoperative aspirin nonuse
|
aspirin 100mg daily until the surgery day
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.
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.
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
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
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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