Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting: The PAPA CABG Study

NCT00330772 | Completed Phase 3

• 1 other identifier: 06-091
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Main Research Question(s): What is the effect of continuing aspirin until the time of coronary artery bypass graft surgery and of adding clopidogrel to aspirin after coronary artery bypass graft surgery for preventing blockage of coronary grafts, heart attack, stroke, and death? To reliably answer this question requires a large randomised trial. Before applying for a major grant from the Canadian Institute for Health Research to do the large study we would like to perform a small pilot study of 150 patients to demonstrate that it is feasible to recruit patients and to use a new test called "CT angiography" to determine whether the bypass grafts are still working or have become blocked. (ii) Why is this research important? Coronary artery bypass surgery has made a very important contribution to improving the health and survival of patients with advanced coronary artery disease but still has many problems. One in 10 patients experiences a heart attack at the time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization, and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Antiplatelet drugs such as aspirin and clopidogrel are effective for preventing heart attacks, strokes and deaths but aspirin is usually stopped before coronary artery bypass graft surgery because of concerns about increasing the risk of bleeding. The effectiveness of the combination of clopidogrel and aspirin after surgery has not been evaluated. Our pilot study will provide key information about feasibility that will help us to design and perform a large definitive study in the future. (iii) What is being studied? We will be looking at blood flow in bypass grafts as well as the occurrence of heart attack, stroke, and death. For safety we will be looking at bleeding, transfusion, and need for further surgery because of bleeding. We will also perform laboratory tests of platelet function to measure and compare the effect of the study treatments to prevent blood clots from forming.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Grafting

Keywords

Cardiac Surger; Coronary Artery Bypass Grafting; Graft patency; Aspirin; Clopidogrel; Hemorrhage; Transfusion

Outcome Measures

Primary Outcomes (1)

• Graft patency, MI, Death, Stroke

Secondary Outcomes (1)

• Bleeding, transfusion, re-exploration, Platelet function tests

Interventions

Aspirin DRUG

Clopidogrel DRUG

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Undergoing on-pump, elective coronary artery bypass grafting with at least 2 free grafts
• Patient able to give informed consent

You may not qualify if:

• planned date of surgery is \<5 days from planned recruitment date
• patient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
• allergy to or intolerance of aspirin or clopidogrel
• history of bleeding diathesis, significant GI bleed, ICH, or liver failure
• Patient has known renal failure or contraindication for Cardiac CT Angio
• Patient has had previous cardiac surgery

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• Sun JC, Teoh KH, Lamy A, Sheth T, Ellins ML, Jung H, Yusuf S, Anand S, Connolly S, Whitlock RP, Eikelboom JW. Randomized trial of aspirin and clopidogrel versus aspirin alone for the prevention of coronary artery bypass graft occlusion: the Preoperative Aspirin and Postoperative Antiplatelets in Coronary Artery Bypass Grafting study. Am Heart J. 2010 Dec;160(6):1178-84. doi: 10.1016/j.ahj.2010.07.035.

  PMID: 21146675 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Hemorrhage

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jack CJ Sun, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• John W Eikelboom, MD, MSc

  McMaster University

  STUDY DIRECTOR

• Kevin HT Teoh, MD

  McMaster University

  STUDY CHAIR

• Salim Yusuf, MD, DPhil

  McMaster University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

CA (1)