Trial record 12 of 180 for:    Open Studies | "Coronary Artery Bypass"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00474591
First received: May 16, 2007
Last updated: May 25, 2007
Last verified: May 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Jack CJ Sun, MD    905-537-3134    sunjc2@mcmaster.ca   
Contact: Poonam Sharma, RN    905-521-2100 ext 44071    psharma@ccc.mcmaster.ca   
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
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 by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00474591     History of Changes
Other Study ID Numbers: 06-361
Study First Received: May 16, 2007
Last Updated: May 25, 2007
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 01, 2014