Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Los Angeles, California 90027


Purpose:

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.


Criteria:

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:


Original ID:

KP-RRC-CE1


NCT ID:

NCT02448550


Secondary ID:


Study Acronym:

CALIFORNIA


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:

Terminated


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


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:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

250


Enrollment Type:

Actual


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
Name:Bivalirudin
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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.