- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00402675
Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI (LIPSIA-NSTEMI)
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
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
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
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Regensburg, Germany, 93049
- Krankenhaus der Barmherzigen Brüder
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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)
|
Immediate, early or selective invasive angiography
|
Active Comparator: Early Intervention
Patients with NSTEMI undergo early invasive angiography (12-48 hours)
|
Immediate, early or selective invasive angiography
|
Active Comparator: Selective invasive angiography
Patients with NSTEMI undergo selective invasive angiography
|
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
Sponsor
Investigators
- Principal Investigator: Holger Thiele, Heart Center Leipzig - University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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