Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- University of Leipzig
- Enrollment
- 600
- Locations
- 5
- Primary Endpoint
- peak creatine kinase- MB level
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical symptoms:
- •Instable angina pectoris:
- •Angina at rest \< 24 hours
- •new onset worsening angina within the last weeks with angina at very low threshold \< 24 h
- •Troponin T:
- •Troponin T-elevation ≥ 0,03 μg/l
- •Informed consent
Exclusion Criteria
- •Age \< 18 years
- •Age \> 90 years
- •Hemodynamic instability
- •Cardiogenic shock
- •Warfarin therapy
- •Contraindications for GpIIb/IIIa-inhibitors
- •life expectancy \< 6 months
- •known high bleeding risk
- •Other reasons for Troponin-elevation: Myocarditis, secondary after hypertensive crisis, cardiac decompensation
- •No informed consent
Outcomes
Primary Outcomes
peak creatine kinase- MB level
Time Frame: 5 days
Secondary Outcomes
- Major bleeding complications (GUSTO definition)(30 days)
- Composite: death, re-myocardial infarction, recurrent unstable angina(6 months)