Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

This study has been completed.
H:S Laegeambulance
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
First received: October 19, 2006
Last updated: May 20, 2008
Last verified: May 2008
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.

Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients Redirected for Primary PCI Based on Tele-Transmitted 12-Lead ECGs

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Enrollment: 102
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with STEMI transferred directly to primary PCI based og transmission of a prehospital ECG

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications against primary angioplasty
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00391326

H:S Lægeambulance
Copenhagen, V, Denmark, 1553
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
H:S Laegeambulance
Principal Investigator: Peter Clemmsensen, MD. phD Rigshospitalet, Denmark
  More Information

Responsible Party: Peter Clemmensen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00391326     History of Changes
Other Study ID Numbers: J.nr. 2006-41-6849 
Study First Received: October 19, 2006
Last Updated: May 20, 2008
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
TIMI flow

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Serine Proteinase Inhibitors

ClinicalTrials.gov processed this record on May 25, 2016