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NCT01268917 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01268917
Other study ID # Fuwai Hospital 2010-259
Secondary ID
Status Recruiting
Phase Phase 3
First received December 29, 2010
Last updated December 30, 2010
Start date March 2010

Study information
Verified date March 2010
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug AdministrationChina: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• aspirin
aspirin 100mg daily until the surgery day
• aspirin
aspirin is stopped 5-7 days before operation

Locations
Country Name City State
China Fuwai Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary graft patency examined by CT scan 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 No
Secondary Bleeding, transfusion, re-exploration perioperative Yes
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