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How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention

NCT01519518 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1829

Last updated 2015-05-13

Study results available
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Summary

The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the performance and subsequent outcomes of Primary percutaneous coronary intervention. This will be a pragmatic trial. Interventional procedures will be performed to reflect current and evolving standards, including predominant radial access. All patients will be treated with routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for 'bail out' treatment only.

Conditions

  • Acute ST Elevation Myocardial Infarction

Interventions

DRUG

unfractionated heparin

70 units/kg body weight intravenous

DRUG

Bivalirudin

intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour

Sponsors & Collaborators

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Rod Stables, MA DM FRCP · Liverpool Heart and Chest Hospital, Liverpool, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01519518 on ClinicalTrials.gov