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

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00402675
First received: November 20, 2006
Last updated: January 4, 2010
Last verified: November 2006
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • peak creatine kinase- MB level [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major bleeding complications (GUSTO definition) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite: death, re-myocardial infarction, recurrent unstable angina [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2006
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Klinikum Links der Weser
Bremen, Germany, 28277
University of Leipzig - Heart Center
Leipzig, Germany, 04289
University of Leipzig
Leipzig, Germany, 12103
Städt. Klinikum St. Georg
Leipzig, Germany, 04129
Krankenhaus der Barmherzigen Brüder
Regensburg, Germany, 93049
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Holger Thiele University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Holger Thiele, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00402675     History of Changes
Other Study ID Numbers: Leipzig-4
Study First Received: November 20, 2006
Last Updated: January 4, 2010
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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014