NCT02448550

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2016

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 15, 2015

Last Update Submit

May 23, 2018

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)

    30-days

Secondary Outcomes (2)

  • all cause mortality, myocardial infarction, or unplanned revascularization for ischemia

    30-days

  • Bleeding Academic Research Consortium grade III or V bleeding events

    30-days

Study Arms (2)

bivalirudin

EXPERIMENTAL

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

Drug: Bivalirudin

unfractionated heparin

ACTIVE COMPARATOR

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

Drug: Unfractionated heparin

Interventions

BivalirudinDRUG
bivalirudin
Unfractionated heparinDRUG
unfractionated heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.
  • Age 18 years or older.

You may not qualify if:

  • Inability to obtain consent
  • Emergency cardiac catheterization for ST-segment elevation myocardial infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

MeSH Terms

Interventions

bivalirudinHeparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

May 1, 2015

Primary Completion

May 6, 2016

Study Completion

June 16, 2016

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

US(1)