Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial (CALIFORNIA)

Kaiser Permanente

Status and phase: Terminated; Phase 3

Conditions: Percutaneous Coronary Intervention

Treatments: Drug: Bivalirudin; Drug: Unfractionated heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02448550

KP-RRC-CE1

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

bivalirudin

Experimental group

Description:

Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.

Treatment:

Drug: Bivalirudin

unfractionated heparin

Active Comparator group

Description:

Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.

Treatment:

Drug: Unfractionated heparin