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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
  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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
unfractionated heparinUnfractionated heparinUnfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
bivalirudinBivalirudinBivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
Primary Outcome Measures
NameTimeMethod
Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)30-days
Secondary Outcome Measures
NameTimeMethod
all cause mortality, myocardial infarction, or unplanned revascularization for ischemia30-days
Bleeding Academic Research Consortium grade III or V bleeding events30-days

Trial Locations

Locations (1)

Kaiser Permanente Los Angeles Medical Center

🇺🇸

Los Angeles, California, United States

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