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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00474591
Recruitment Status : Unknown
Verified May 2007 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : May 17, 2007
Last Update Posted : May 28, 2007
Information provided by:
McMaster University

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.

Condition or disease Intervention/treatment Phase
Coronary Bypass Graft Failure/Occlusion Drug: Fondaparinux Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Graft patency [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Myocardial infarction [ Time Frame: In-hospital ]
  2. Stroke [ Time Frame: In-hospital ]
  3. Death [ Time Frame: In-hospital ]
  4. Bleeding events [ Time Frame: In-hospital, 28 days ]
  5. Transfusion requirements [ Time Frame: In-hospital ]
  6. Re-operation [ Time Frame: In-hospital ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00474591

Contact: Jack CJ Sun, MD 905-537-3134
Contact: Poonam Sharma, RN 905-521-2100 ext 44071

Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Jack CJ Sun, MD    905-537-3134   
Contact: Poonam Sharma, RN    905-521-2100 ext 44071   
Principal Investigator: Jack CJ Sun, MD         
Sub-Investigator: John W Eikelboom, MD,MSc         
Sub-Investigator: Mary Lou Ellins, MD         
Sub-Investigator: Tej Sheth, MD         
Sub-Investigator: Theodore Warkentin, MD         
Sub-Investigator: Andre Lamy, MD,MSc         
Sub-Investigator: Sonia Anand, MD,MSc,PhD         
Sub-Investigator: Salim Yusuf, MD,DPhil         
Sub-Investigator: Kevin HT Teoh, MD,MSc         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Jack CJ Sun, MD McMaster University
Study Director: John W Eikelboom, MD,MSc McMaster University
Study Chair: Kevin HT Teoh, MD,MSc McMaster University
Study Chair: Salim Yusuf, MD,DPhil McMaster University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00474591     History of Changes
Other Study ID Numbers: 06-361
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007

Keywords provided by McMaster University:
Coronary artery bypass surgery, fondaparinux, graft patency, graft occlusion, graft failure, anticoagulation

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents