Acute Coronary Syndromes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSwitching from Fondaparinux to Bivalirudin or Unfractionated Heparin
Sponsors
GlaxoSmithKline
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 1. ST elevated myocardial infarction within the preceding 48 hours; 2. Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg); 3. Patients presenting on or received bivalirudin, GP IIb/IIIa inhibitors or low-molecular weight heparin within the preceding 24 hours; 4. Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration. 5. Patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (GI bleed etc.); 6. Known diagnosis of acute bacterial endocarditis; 7. Patients with cardiogenic shock or required intra-aortic balloon pump (IABP) 8. If patient is on warfarin (Coumadin) therapy; 9. Patients who had a major or minor stroke (CVA or TIA) or major surgery within the past 6 months; 10. Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L),) status post renal transplant, patients on chronic dialysis or creatinine clearance ≤ 30 ml/min; 11. A platelet count of less than 100,000 cells/mm3; 12. Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, or contrast that cannot be medically managed; 13. Prior angioplasty within the previous 30 days; 14. Contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin; 15. Pregnant or lactating women; 16. Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study; 17. Currently participating in an investigational drug or another device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During hospitalization, after Fondaparinux administration, prior to randomization | Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | during index hospitalization | Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis |
Countries
Canada, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Heparin unfrationated heparin during angioplasty | 49 |
| Bivalirudin bivalirudin during angioplasty | 51 |
| 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. | 29 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | No PCI per inclusion criteria | 0 | 0 | 29 |
Baseline characteristics
| Characteristic | Heparin | Bivalirudin | Screen Failures | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 24 Participants | 7 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 27 Participants | 22 Participants | 80 Participants |
| Age Continuous | 62.18 years STANDARD_DEVIATION 13.36 | 63.33 years STANDARD_DEVIATION 12.17 | 54.45 years STANDARD_DEVIATION 13.62 | 60.45 years STANDARD_DEVIATION 14.42 |
| Region of Enrollment Canada | 33 participants | 33 participants | 0 participants | 66 participants |
| Region of Enrollment United States | 16 participants | 18 participants | 29 participants | 63 participants |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 8 Participants | 40 Participants |
| Sex: Female, Male Male | 31 Participants | 37 Participants | 21 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 49 | 4 / 51 | 0 / 0 |
| serious Total, serious adverse events | 0 / 49 | 1 / 51 | 0 / 0 |
Outcome results
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)
Time frame: During hospitalization, after Fondaparinux administration, prior to randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heparin | 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 | 0 participants |
| Bivalirudin | 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 | 0 participants |
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)
Time frame: During hospitalization, after randomization, during PCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heparin | 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 | 0 participants |
| Bivalirudin | 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 | 0 participants |
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)
Time frame: During hospitalization, after PCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heparin | 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 | 0 participants |
| Bivalirudin | 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 | 1 participants |
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
Time frame: during index hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heparin | 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 | 4 participants |
| Bivalirudin | 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 | 4 participants |