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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402675

Acronym

LIPSIA-NSTEMI

Enrollment

600

Registered

2006-11-22

Start date

2006-07-31

Completion date

2010-01-31

Last updated

2010-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

NSTEMI, infarction, treatment, percutaneous coronary intervention, non-ST-elevation myocardial infarction

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.

Interventions

PROCEDURETiming of percutaneous coronary intervention

Immediate, early or selective invasive angiography

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

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

Design outcomes

Primary

Measure	Time frame
peak creatine kinase- MB level	5 days

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026