Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients
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.
Acute Myocardial Infarction
|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|
|Study Start Date:||November 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391326
|Copenhagen, V, Denmark, 1553|
|Copenhagen, Ø, Denmark, 2100|
|Principal Investigator:||Peter Clemmsensen, MD. phD||Rigshospitalet, Denmark|