Clinical trial NCT00402675: Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI
Official title: Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: NSTEMI
infarction
treatment
percutaneous coronary intervention
non-ST-elevation myocardial infarction
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2006-11-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: peak creatine kinase- MB level
timeFrame: 5 days
Secondary outcomes:
measure: Major bleeding complications (GUSTO definition)
timeFrame: 30 days
measure: Composite: death, re-myocardial infarction, recurrent unstable angina
timeFrame: 6 months
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Leipzig
country: Germany
facility: Städt. Klinikum St. Georg
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
city: Leipzig
country: Germany
facility: University of Leipzig
city: Regensburg
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thiele H, Rach J, Klein N, Pfeiffer D, Hartmann A, Hambrecht R, Sick P, Eitel I, Desch S, Schuler G; LIPSIA-NSTEMI Trial Group. Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: the Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial). Eur Heart J. 2012 Aug;33(16):2035-43. doi: 10.1093/eurheartj/ehr418. Epub 2011 Nov 21.