Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391326
Status:
COMPLETED
Last Update Posted:
2008-05-21
First Post:
2006-10-19
Brief Title:
Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients Redirected for Primary PCI Based on Tele-Transmitted 12-Lead ECGs
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cardiologists 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None