NCT00402675

Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI

Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this randomized, controlled, open-label clinical trial we compare a very early cardiac catheterization (\< 2,5 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 mg/d and tirofiban for 24 hours.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Timing of percutaneous coronary intervention	Immediate, early or selective invasive angiography

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2006-11-22
• Last updated: 2010-01-05

Locations

5 sites across 1 country: Germany