The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.
This is a prospective open label, randomized, multi-center registry. One hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. The patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. All patients will be followed throughout the duration of the hospital stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Bridgeport Hospital
Bridgeport, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Time frame: During hospitalization, after Fondaparinux administration, prior to randomization
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Time frame: During hospitalization, after randomization, during PCI
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)
Time frame: During hospitalization, after PCI
Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis
Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis
Time frame: during index hospitalization
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University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Hamilton General Hospital
Hamilton, Ontario, Canada
Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval)
Québec, Quebec, Canada