Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI (LIPSIA-NSTEMI)

University of Leipzig

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Procedure: Timing of percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00402675

Leipzig-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. Troponin T:

   Troponin T-elevation ≥ 0,03 μg/l

3. Informed consent

Exclusion criteria

1. Age < 18 years
2. Age > 90 years
3. STEMI
4. Hemodynamic instability
5. Cardiogenic shock
6. Warfarin therapy
7. Contraindications for GpIIb/IIIa-inhibitors
8. life expectancy < 6 months
9. known high bleeding risk
10. Pregnancy
11. Other reasons for Troponin-elevation: Myocarditis, secondary after hypertensive crisis, cardiac decompensation
12. No informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Immediate Intervention

Active Comparator group

Description:

Patients with NSTEMI undergo immediate invasive angiography (\< 2 hours)

Treatment:

Procedure: Timing of percutaneous coronary intervention

Early Intervention

Active Comparator group

Description:

Patients with NSTEMI undergo early invasive angiography (12-48 hours)

Treatment:

Procedure: Timing of percutaneous coronary intervention

Selective invasive angiography

Active Comparator group

Description:

Patients with NSTEMI undergo selective invasive angiography

Treatment:

Procedure: Timing of percutaneous coronary intervention