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

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02448550
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 2
• Duration (Months): 13.5
• Patients Per Site Per Month: 18.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention	Drug: Bivalirudin; Drug: Unfractionated heparin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: May 6, 2016
• Actual Study Completion Date: Jun 16, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. all cause mortality, myocardial infarction, or unplanned revascularization for ischemia [30-days]

2. Bleeding Academic Research Consortium grade III or V bleeding events [30-days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027

Sponsors and Collaborators

• Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02448550
• Other Study ID Numbers: KP-RRC-CE1
• First Posted: May 19, 2015
• Last Update Posted: May 24, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Heparin; Calcium heparin; Bivalirudin

Study Results

No Results Posted as of May 24, 2018