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The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bivalirudin | Experimental | Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. |
|
| unfractionated heparin | Active Comparator | Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug |
| ||
| Unfractionated heparin |
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints) | 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality, myocardial infarction, or unplanned revascularization for ischemia | 30-days | |
| Bleeding Academic Research Consortium grade III or V bleeding events | 30-days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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