Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI (LIPSIA-NSTEMI)
This study has been completed.
Sponsor:
University of Leipzig
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00402675
First received: November 20, 2006
Last updated: January 4, 2010
Last verified: November 2006
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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:
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
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 May 22, 2013