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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Timing of percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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 STEMI Hemodynamic instability Cardiogenic shock Warfarin therapy Contraindications for GpIIb/IIIa-inhibitors life expectancy < 6 months known high bleeding risk Pregnancy Other reasons for Troponin-elevation: Myocarditis, secondary after hypertensive crisis, cardiac decompensation No informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Intervention<br>Patients with NSTEMI undergo immediate invasive angiography (< 2 hours) | Procedure: Timing of percutaneous coronary intervention<br>* Immediate, early or selective invasive angiography<br>|
| Active Comparator: Early Intervention<br>Patients with NSTEMI undergo early invasive angiography (12-48 hours) | Procedure: Timing of percutaneous coronary intervention<br>* Immediate, early or selective invasive angiography<br>|
| Active Comparator: Selective invasive angiography<br>Patients with NSTEMI undergo selective invasive angiography | Procedure: Timing of percutaneous coronary intervention<br>* Immediate, early or selective invasive angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak creatine kinase- MB level |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding complications (GUSTO definition) |  | 30 days | 
| Composite: death, re-myocardial infarction, recurrent unstable angina |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSTEMI, infarction, treatment, percutaneous coronary intervention, non-ST-elevation myocardial infarction