Expired Study
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Los Angeles, California 90027


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.


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 is Available At:

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Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Kaiser Permanente

Oversight Authority:

United States: Data and Safety Monitoring Board

Reasons Why Stopped:

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Study Design:

Number of Arms:


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Study Dates

Start Date:May 2015
Completion Date:June 16, 2016
Completion Type:Actual
Primary Completion Date:May 6, 2016
Primary Completion Type:Actual
Verification Date:May 2018
Last Changed Date:May 23, 2018
First Received Date:May 15, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Bleeding Academic Research Consortium grade III or V bleeding events
Time Frame:30-days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:all cause mortality, myocardial infarction, or unplanned revascularization for ischemia
Time Frame:30-days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)
Time Frame:30-days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Arm Name:bivalirudin
Intervention Type:Drug
Name:Unfractionated heparin
Arm Name:unfractionated heparin

Study Arms

Study Arm Type:Active Comparator
Arm Name:unfractionated heparin
Description:Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.
Study Arm Type:Experimental
Arm Name:bivalirudin
Description:Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Kaiser Permanente

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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