Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI - Full Text View

Sponsored by:	University of Leipzig
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00402675

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Procedure: Timing of percutaneous coronary intervention	Phase IV

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

Composite: death, re-myocardial infarction, recurrent unstable angina within 6 months

Secondary Outcome Measures:

Safety:
Major bleeding complications

Estimated Enrollment:	600
Study Start Date:	July 2006

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

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402675

Contacts

Contact: Holger Thiele, MD, PhD

+493418651428

thielh@medizin.uni-leipzig.de

Locations

Germany
University of Leipzig - Heart Center	Recruiting
Leipzig, Germany, 04289

Sponsors and Collaborators

University of Leipzig

Investigators

Principal Investigator:

Holger Thiele

University of Leipzig

More Information

Study ID Numbers:	Leipzig-4
Study First Received:	November 20, 2006
Last Updated:	November 21, 2006
ClinicalTrials.gov Identifier:	NCT00402675
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

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

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009