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

NCT ID: NCT02448550

Last Updated: 2018-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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bivalirudin

Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

unfractionated heparin

Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.

Group Type ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type DRUG

Interventions

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Bivalirudin

Intervention Type DRUG

Unfractionated heparin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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KP-RRC-CE1

Identifier Type: -

Identifier Source: org_study_id

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