Coronary Bypass Graft Failure/Occlusion Clinical Trial
— Fonda CABGOfficial title:
Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery
| NCT number | NCT00474591 |
| Other study ID # | 06-361 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | Phase 3 |
| First received | May 16, 2007 |
| Last updated | May 25, 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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hamilton General Hospital | Hamilton | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Hamilton Health Sciences Corporation | GlaxoSmithKline |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Graft patency | 28 days | ||
| Secondary | Myocardial infarction | In-hospital | ||
| Secondary | Stroke | In-hospital | ||
| Secondary | Death | In-hospital | ||
| Secondary | Bleeding events | In-hospital, 28 days | ||
| Secondary | Transfusion requirements | In-hospital | ||
| Secondary | Re-operation | In-hospital |