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

May 23, 2018 updated by: Kaiser Permanente

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bivalirudin
Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
Drug: Bivalirudin
Active Comparator: unfractionated heparin
Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
Drug: Unfractionated heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)
Time Frame: 30-days
30-days

Secondary Outcome Measures

Outcome Measure
Time Frame
all cause mortality, myocardial infarction, or unplanned revascularization for ischemia
Time Frame: 30-days
30-days
Bleeding Academic Research Consortium grade III or V bleeding events
Time Frame: 30-days
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 6, 2016

Study Completion (Actual)

June 16, 2016

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KP-RRC-CE1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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