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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin | Active Comparator | Patients are switched from fondaparinux to heparin, receiving a dose of 60 U/Kg IV during the PCI |
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| Bivalirudin | Active Comparator | Patients switched from fondaparinux to bivalirudin, received a bolus of 0.75 mg/kg IV followed by infusion of 1.75 mg/g per hour infusion during the PCI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switching from Fondaparinux to Bivalirudin or Unfractionated Heparin | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | During hospitalization, after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
1. The patient is, male or female, > 18 years of age; 2. The patient presents with coronary syndrome, unstable angina or non ST segment elevated myocardial infarction (NSTEMI) defined as at least one of the following criteria:
Elevated creatine kinase MB or Troponin I or T (above ULN)
ECG changes indicative of ischemia 3. The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease; 4. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
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| Name | Affiliation | Role |
|---|---|---|
| Ron Waksman, MD | Washington Hospital Center, Washington, DC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States | ||
| Washington Hospital Center |
Patients who were enrolled and received fondaparinux and who did not have sufficient disease requiring any revascularization procedure will be followed through the duration of the hospitalization. Patients will have a complete blood count (CBC) prior to discharge. These patients are enrolled, but considered screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Heparin | All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV. |
| FG001 | Bivalirudin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| during index hospitalization |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Baptist Cardiac and Vascular Institute | Miami | Florida | 33176 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Hamilton General Hospital | Hamilton | Ontario | L8L2X2 | Canada |
| Institut Universitaire de cardiologie et de Pneumologie de Québec (Hôpital Laval) | Québec | Quebec | G1V 4G5 | Canada |
All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI. |
| FG002 | Screen Failures | These patients were enrolled because they received study drug, but did not have enough disease to require PCI. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Heparin | unfrationated heparin during angioplasty |
| BG001 | Bivalirudin | bivalirudin during angioplasty |
| BG002 | Screen Failures | Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | participants | During hospitalization, after Fondaparinux administration, prior to randomization |
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| Secondary | 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 | Posted | Number | participants | during index hospitalization |
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| Primary | 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) | Posted | Number | participants | During hospitalization, after randomization, during PCI |
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| Primary | 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) | Posted | Number | participants | During hospitalization, after PCI |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heparin | unfrationated heparin during angioplasty | 0 | 49 | 4 | 49 | ||
| EG001 | Bivalirudin | bivalirudin during angioplasty | 1 | 51 | 4 | 51 | ||
| EG002 | Screen Failures | Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention. | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major Bleed | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Site Complication | Vascular disorders |
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| Dissection | Cardiac disorders |
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| Ventricular fibrillation | Cardiac disorders |
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| Repeat revascularization | Cardiac disorders |
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This trial included only small number of patients and is not powered to detect intergroup differences
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Waksman, MD | Medstar Health Research Institute | 202-877-2812 | ron.waksman@medstar.net |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Canada |
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