Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial
Phase 3
Terminated
- Conditions
- Percutaneous Coronary Intervention
- Interventions
- Registration Number
- NCT02448550
- Lead Sponsor
- Kaiser Permanente
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.
- Age 18 years or older.
Exclusion Criteria
- Inability to obtain consent
- Emergency cardiac catheterization for ST-segment elevation myocardial infarction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description unfractionated heparin Unfractionated heparin Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted. bivalirudin Bivalirudin Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
- Primary Outcome Measures
Name Time Method Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints) 30-days
- Secondary Outcome Measures
Name Time Method all cause mortality, myocardial infarction, or unplanned revascularization for ischemia 30-days Bleeding Academic Research Consortium grade III or V bleeding events 30-days
Trial Locations
- Locations (1)
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States