Full Text View
Tabular View
No Study Results Posted
Related Studies
Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery: The Fonda CABG Study
This study is not yet open for participant recruitment.
Verified by McMaster University, May 2007
First Received: May 16, 2007   Last Updated: May 25, 2007   History of Changes
Sponsors and Collaborators: Hamilton Health Sciences
GlaxoSmithKline
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00474591
  Purpose

(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 Intervention Phase
Coronary Bypass Graft Failure/Occlusion
Drug: Fondaparinux
Phase III

MedlinePlus related topics: Blood Thinners Coronary Artery Bypass Surgery Heart Attack Surgery
Drug Information available for: ORG 31540 Fondaparinux sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery

Further study details as provided by McMaster University:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474591

Contacts
Contact: Jack CJ Sun, MD 905-537-3134 sunjc2@mcmaster.ca
Contact: Poonam Sharma, RN 905-521-2100 ext 44071 psharma@ccc.mcmaster.ca

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences
GlaxoSmithKline
Investigators
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
  More Information

No publications provided

Study ID Numbers: 06-361
Study First Received: May 16, 2007
Last Updated: May 25, 2007
ClinicalTrials.gov Identifier: NCT00474591     History of Changes
Health Authority: Canada: Health Canada

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

Study placed in the following topic categories:
Fibrin Modulating Agents
Anticoagulants
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Heparin
Org 31540
Calcium heparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Pharmacologic Actions
Org 31540

ClinicalTrials.gov processed this record on May 07, 2009