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Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00391326
Collaborator
H:S Laegeambulance (Other)
102
Enrollment
2
Locations
17
Duration (Months)
51
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    102 participants
    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
    Study Start Date :
    Nov 1, 2006
    Actual Primary Completion Date :
    Apr 1, 2008
    Actual Study Completion Date :
    Apr 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • ST elevation acute myocardial infarction patients redirected for primary angioplasty

      • Symptoms less than 12 hours

      Exclusion Criteria:
      • Contraindications against primary angioplasty

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 H:S Lægeambulance Copenhagen V Denmark 1553
      2 Rigshospitalet Copenhagen Denmark 2100

      Sponsors and Collaborators

      • Rigshospitalet, Denmark
      • H:S Laegeambulance

      Investigators

      • Principal Investigator: Peter Clemmsensen, MD. phD, Rigshospitalet, Denmark

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00391326
      Other Study ID Numbers:
      • J.nr. 2006-41-6849
      First Posted:
      Oct 23, 2006
      Last Update Posted:
      May 21, 2008
      Last Verified:
      May 1, 2008
      Keywords provided by , ,
      Bivalirudin
      Heparin
      Bleeding
      TIMI flow
      STEMI
      Additional relevant MeSH terms:
      Myocardial Infarction
      Infarction

      Study Results

      No Results Posted as of May 21, 2008