Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474591
Status:
UNKNOWN
Last Update Posted:
2007-05-28
First Post:
2007-05-16
Brief Title:
Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery The Fonda CABG Study
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fonda CABG
Brief Summary:
i Main Research Questions 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None