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Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

NCT ID: NCT00391326

Last Updated: 2008-05-21

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

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to describe the efficacy and safety of prehospital administration of bivalirudin, as a substitute for heparin, in patients with acute myocardial infarction redirected for primary angioplasty bypassing local hospitals, immediately after the diagnosis is confirmed via tele-transmission of a 12-lead electrocardiogram.

Detailed Description

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Primary angioplasty (pPCI) is the therapy of choice in patients with ST elevation acute myocardial infarction (STEMI) in Denmark. However, time is lost transferring patients from a local hospital to an invasive treatment centre. Time can be saved by redirecting STEMI patients to pPCI based on wireless prehospital 12-lead electrocardiogram (ECG) transmission directly to a cardiologist's handheld device. To prevent complications during the transportation of STEMI patients to the invasive hospital, patients are treated with oxygen, aspirin, clopidogrel, heparin, and nitro-glycerine in the ambulance. However, heparin use is cumbersome for the ambulance personnel since it must be kept at 5 degrees Celsius. An alternative to heparin may be bivalirudin, since it can be kept at room temperature and thus is easily administered in the prehospital setting.

Comparison: Heparin versus bivalirudin treatment. Efficacy is determined by thrombolysis in myocardial infarction (TIMI) flow in the first and final coronary angiogram. Safety is determined by the rate of bleeding complication.

Conditions

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Acute Myocardial Infarction

Keywords

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Bivalirudin Heparin Bleeding TIMI flow STEMI

Study Design

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Observational Model Type

CASE_CONTROL

Eligibility Criteria

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Inclusion Criteria

* ST elevation acute myocardial infarction patients redirected for primary angioplasty
* Symptoms less than 12 hours

Exclusion Criteria

* Contraindications against primary angioplasty
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H:S Laegeambulance

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Rigshospitalet

Principal Investigators

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Peter Clemmsensen, MD. phD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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H:S Lægeambulance

Copenhagen, V, Denmark

Site Status

Rigshospitalet

Copenhagen, Ø, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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J.nr. 2006-41-6849

Identifier Type: -

Identifier Source: org_study_id