Percutaneous Coronary Intervention Clinical Trial
— CALIFORNIAOfficial title:
Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction
| NCT number | NCT02448550 |
| Other study ID # | KP-RRC-CE1 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 2015 |
| Est. completion date | June 16, 2016 |
| Verified date | May 2018 |
| Source | Kaiser Permanente |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 250 |
| Est. completion date | June 16, 2016 |
| Est. primary completion date | May 6, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction. 2. Age 18 years or older. Exclusion Criteria: 1. Inability to obtain consent 2. Emergency cardiac catheterization for ST-segment elevation myocardial infarction. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Kaiser Permanente |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints) | 30-days | ||
| Secondary | all cause mortality, myocardial infarction, or unplanned revascularization for ischemia | 30-days | ||
| Secondary | Bleeding Academic Research Consortium grade III or V bleeding events | 30-days |
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