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OpenTrials
Completed

NCT Number: NCT00402675

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinikum Links der Weser, Bremen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Timing of percutaneous coronary intervention

Procedure

Immediate, early or selective invasive angiography

Primary outcomes

  1. peak creatine kinase- MB level

    Time frame: 5 days

Secondary outcomes

  1. Major bleeding complications (GUSTO definition)

    Time frame: 30 days

  2. Composite: death, re-myocardial infarction, recurrent unstable angina

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: LIPSIA-NSTEMI

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Nov 22, 2006
Registry last updated
Jan 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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