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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02448550
Other study ID # KP-RRC-CE1
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 2015
Est. completion date June 16, 2016

Study information

Verified date May 2018
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 250
Est. completion date June 16, 2016
Est. primary completion date May 6, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Percutaneous Coronary Intervention

Intervention

Drug:
Bivalirudin

Unfractionated heparin


Locations

Country Name City State
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

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