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

Myocardial Infarction Clinical Trial

— LIPSIA-NSTEMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402675
• Other study ID #: Leipzig-4
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2006
• Last updated: January 4, 2010
• Start date: July 2006
• Est. completion date: January 2010

Study information

• Verified date: November 2006
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Timing of percutaneous coronary intervention
Immediate, early or selective invasive angiography

Locations

Country	Name	City	State
Germany	Klinikum Links der Weser	Bremen
Germany	Städt. Klinikum St. Georg	Leipzig
Germany	University of Leipzig	Leipzig
Germany	University of Leipzig - Heart Center	Leipzig
Germany	Krankenhaus der Barmherzigen Brüder	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak creatine kinase- MB level		5 days	No
Secondary	Major bleeding complications (GUSTO definition)		30 days	Yes
Secondary	Composite: death, re-myocardial infarction, recurrent unstable angina		6 months	No