Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

This study has been completed.
Sponsor:
Collaborator:
H:S Laegeambulance
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00391326
First received: October 19, 2006
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

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
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.

  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391326

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

No publications provided

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:
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
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014