Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients

Acute Myocardial Infarction Clinical Trial

Official title:

Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients Redirected for Primary PCI Based on Tele-Transmitted 12-Lead ECGs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391326
• Other study ID #: J.nr. 2006-41-6849
• Status: Completed
• Phase: N/A
• First received: October 19, 2006
• Last updated: May 20, 2008
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Denmark	H:S Lægeambulance	Copenhagen	V
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	H:S Laegeambulance

Country where clinical trial is conducted

Denmark,