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

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01268917
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2

Study Details

Study Description

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; Drug: aspirin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2010
• Anticipated Primary Completion Date: Mar 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. graft patency examined by CT scan [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 [perioperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing		China	100037

Sponsors and Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01268917
• Other Study ID Numbers: Fuwai Hospital 2010-259
• First Posted: Dec 31, 2010
• Last Update Posted: Dec 31, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: coronary artery disease; off-pump coronary artery bypass; aspirin
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aspirin

Study Results

No Results Posted as of Dec 31, 2010