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

NCT01268917 | Unknown Phase 3 DMC

• 1 other identifier: Fuwai Hospital 2010-259
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Off-pump Coronary Artery Bypass; Aspirin

Keywords

coronary artery disease; off-pump coronary artery bypass; aspirin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Bleeding, transfusion, re-exploration

  perioperative

Study Arms (2)

preoperative aspirin use

EXPERIMENTAL

Drug: aspirin

preoperative aspirin nonuse

NO INTERVENTION

Drug: aspirin

Interventions

aspirin DRUG

aspirin 100mg daily until the surgery day

preoperative aspirin use

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective, off-pump coronary artery bypass with at least two grafts
• patient able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital

Beijing, 100037, China

RECRUITING

Related Publications (1)

• Chen S, Wu H, Yang T, Li B, Hu Y, Sun H. Does Early Graft Patency Benefit from Perioperative Statin Therapy? A Propensity Score-Matched Study of Patients Undergoing Off-Pump Coronary Artery Bypass Surgery. Cardiovasc Ther. 2019 Aug 6;2019:1582183. doi: 10.1155/2019/1582183. eCollection 2019.

  PMID: 31772605 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 31, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Last Updated: December 31, 2010

Record last verified: 2010-03

Locations

CN (1)