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

Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02448550
Acronym
CALIFORNIA
Enrollment
250
Registered
2015-05-19
Start date
2015-05-31
Completion date
2016-06-16
Last updated
2018-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Intervention

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.

Interventions

DRUGBivalirudin
DRUGUnfractionated heparin

Sponsors

Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)30-days

Secondary

MeasureTime frame
all cause mortality, myocardial infarction, or unplanned revascularization for ischemia30-days
Bleeding Academic Research Consortium grade III or V bleeding events30-days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026