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Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

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ClinicalTrials.gov Identifier: NCT00391326
Recruitment Status : Completed
First Posted : October 23, 2006
Last Update Posted : May 21, 2008
Sponsor:
Collaborator:
H:S Laegeambulance
Information provided by:
Rigshospitalet, Denmark

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
Acute Myocardial Infarction

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 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 : November 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Bivalirudin





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications against primary angioplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391326


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

Responsible Party: Peter Clemmensen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00391326     History of Changes
Other Study ID Numbers: J.nr. 2006-41-6849
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008

Keywords provided by Rigshospitalet, Denmark:
Bivalirudin
Heparin
Bleeding
TIMI flow
STEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants