Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI (LIPSIA-NSTEMI)

January 4, 2010 updated by: University of Leipzig

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bremen, Germany, 28277
        • Klinikum Links der Weser
      • Leipzig, Germany, 04289
        • University of Leipzig - Heart Center
      • Leipzig, Germany, 04129
        • Städt. Klinikum St. Georg
      • Leipzig, Germany, 12103
        • University of Leipzig
      • Regensburg, Germany, 93049
        • Krankenhaus der Barmherzigen Brüder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Intervention
Patients with NSTEMI undergo immediate invasive angiography (< 2 hours)
Procedure: Timing of percutaneous coronary intervention
Immediate, early or selective invasive angiography
Active Comparator: Early Intervention
Patients with NSTEMI undergo early invasive angiography (12-48 hours)
Procedure: Timing of percutaneous coronary intervention
Immediate, early or selective invasive angiography
Active Comparator: Selective invasive angiography
Patients with NSTEMI undergo selective invasive angiography
Procedure: Timing of percutaneous coronary intervention
Immediate, early or selective invasive angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peak creatine kinase- MB level
Time Frame: 5 days
5 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Holger Thiele, Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 5, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leipzig-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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