Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402675
Status:
COMPLETED
Last Update Posted:
2010-01-05
First Post:
2006-11-20
Brief Title:
Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI
Sponsor:
University of Leipzig
Organization:
University of Leipzig
Study Overview
Official Title:
Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
Status:
COMPLETED
Status Verified Date:
2006-11
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:
LIPSIA-NSTEMI
Brief Summary:
In non-ST-elevation the optimal time of percutaneous coronary intervention PCI is unclear
Some studies showed benefit of very early PCI some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test
The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial
Some studies showed benefit of very early PCI some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test
The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial
Detailed Description:
In this randomized controlled open-label clinical trial we compare a very early cardiac catheterization 25 hours after randomization similar to ST-elevation myocardial infarction treatment versus an early invasive approach within 2-48 hours after randomization versus a selective invasive approach in patients with non-ST-elevation myocardial infarction
All patients are treated with heparin ASA Clopidogrel loading dose 600 mg with subsequent 75 mgd and tirofiban for 24 hours
All patients are treated with heparin ASA Clopidogrel loading dose 600 mg with subsequent 75 mgd and tirofiban for 24 hours
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