Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery: The Fonda CABG Study

NCT00474591 | Unknown Phase 3

• 1 other identifier: 06-361
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

(i) Main Research Question(s): What is the effect of fondaparinux on coronary graft patency, heart attack, stroke, and death in patients who have undergone coronary artery bypass grafting (CABG)? To reliably answer this question requires a large randomised trial. We propose a pilot study to demonstrate the feasibility of recruiting patients into this study and of performing CT angiograms to measure graft patency at 30 days. (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. Fondaparinux, a relatively new anticoagulant drug, has been shown to significantly reduce cardiovascular events and death in patients who have suffered a recent heart attack. Compared to established anticoagulant therapies for acute myocardial infarction, fondaparinux has been shown to be more effective with similar or lower risks of bleeding. Fondaparinux, unlike the most commonly used anticoagulants, does not cause Heparin Induced Thrombocytopenia (HIT), a rare condition with extremely high morbidity and mortality. This drug has never been studied in CABG patients. 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, heart attack, stroke, venous thromboembolism 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 for HIT antibodies as their levels are prognostic for the development of HIT and are also related to morbidity and mortality. The incidence of actual HIT cases will also be recorded.

Conditions

Coronary Bypass Graft Failure/Occlusion

Keywords

Coronary artery bypass surgery, fondaparinux, graft patency, graft occlusion, graft failure, anticoagulation

Outcome Measures

Primary Outcomes (1)

• Graft patency

  28 days

Secondary Outcomes (6)

• Myocardial infarction

  In-hospital

• Stroke

  In-hospital

• Death

  In-hospital

• Bleeding events

  In-hospital, 28 days

• Transfusion requirements

  In-hospital

Interventions

Fondaparinux DRUG

Eligibility Criteria

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

You may qualify if:

• age at least 18 years
• undergoing first ever multivessel CABG-only surgery with at least 2 free grafts (e.g. Radial artery, saphenous vein, free internal mammary artery)
• undergoing CABG with cardiopulmonary bypass

You may not qualify if:

• clear indication for anticoagulation (e.g. prosthetic heart valve replacement, recurrent DVT)
• allergy or intolerance of fondaparinux or unfractionated heparin
• renal failure or other contraindication for coronary artery graft CT angiogram
• inability to provide informed consent

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• Warkentin TE, Sheppard JI, Sun JC, Jung H, Eikelboom JW. Anti-PF4/heparin antibodies and venous graft occlusion in postcoronary artery bypass surgery patients randomized to postoperative unfractionated heparin or fondaparinux thromboprophylaxis. J Thromb Haemost. 2013 Feb;11(2):253-60. doi: 10.1111/jth.12098.

  PMID: 23216710 DERIVED

MeSH Terms

Conditions

Bites and Stings

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Jack CJ Sun, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• John W Eikelboom, MD,MSc

  McMaster University

  STUDY DIRECTOR

• Kevin HT Teoh, MD,MSc

  McMaster University

  STUDY CHAIR

• Salim Yusuf, MD,DPhil

  McMaster University

  STUDY CHAIR

Central Study Contacts

Jack CJ Sun, MD

CONTACT

905-537-3134; sunjc2@mcmaster.ca

Poonam Sharma, RN

CONTACT

905-521-2100; psharma@ccc.mcmaster.ca

Study Design

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

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Last Updated: May 28, 2007

Record last verified: 2007-05

Locations

CA (1)