Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00391326
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-19
• Study First Posted: 2006-10-23
• Study Start: 2006-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-20
• Last Update Posted: 2008-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

• Contraindications against primary angioplasty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

H:S Lægeambulance; 🇩🇰 Copenhagen, V, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark