Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery: The Fonda CABG Study (Fonda CABG)
|ClinicalTrials.gov 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
(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|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery|
- Graft patency [ Time Frame: 28 days ]
- Myocardial infarction [ Time Frame: In-hospital ]
- Stroke [ Time Frame: In-hospital ]
- Death [ Time Frame: In-hospital ]
- Bleeding events [ Time Frame: In-hospital, 28 days ]
- Transfusion requirements [ Time Frame: In-hospital ]
- Re-operation [ Time Frame: In-hospital ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474591
|Contact: Jack CJ Sun, MDfirstname.lastname@example.org|
|Contact: Poonam Sharma, RN||905-521-2100 ext email@example.com|
|Hamilton General Hospital||Not yet recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Contact: Jack CJ Sun, MD 905-537-3134 firstname.lastname@example.org|
|Contact: Poonam Sharma, RN 905-521-2100 ext 44071 email@example.com|
|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|
|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|