Clinical Trial:

Regulate-PCI

Full Name

CARDIOLOGY/ A RANDOMIZED, OPEN-LABEL, MULTI-CENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO BIVALIRUDIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (1_PRO00001405)

Eligibility

Inclusion Criteria
  • Must have coronary artery disease (CAD) and be undergoing percutaneous coronary intervention (PCI) as defined in the protocol
  • Must be greater than or equal to 18 years of age
  • Must not have any evidence of history of intracranial bleeding or aneurysm
  • Must not have any planned surgical procedure within 30 days after randomization
  • Must not have a known allergy or intolerance to aspirin, to all available ADP/P2Y12 inhibitors (clopidogrel, prasugel, ticagrelor) or to bivalirudin or REG1 (or any of their respective components)