Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI (LIPSIA-NSTEMI)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Timing of percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring NSTEMI, infarction, treatment, percutaneous coronary intervention, non-ST-elevation myocardial infarction
Eligibility 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
Sites / Locations
- Klinikum Links der Weser
- Städt. Klinikum St. Georg
- University of Leipzig - Heart Center
- University of Leipzig
- Krankenhaus der Barmherzigen Brüder
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Immediate Intervention
Early Intervention
Selective invasive angiography
Arm Description
Patients with NSTEMI undergo immediate invasive angiography (< 2 hours)
Patients with NSTEMI undergo early invasive angiography (12-48 hours)
Patients with NSTEMI undergo selective invasive angiography
Outcomes
Primary Outcome Measures
peak creatine kinase- MB level
Secondary Outcome Measures
Major bleeding complications (GUSTO definition)
Composite: death, re-myocardial infarction, recurrent unstable angina
Full Information
NCT ID
NCT00402675
First Posted
November 20, 2006
Last Updated
January 4, 2010
Sponsor
University of Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT00402675
Brief Title
Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI
Acronym
LIPSIA-NSTEMI
Official Title
Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
NSTEMI, infarction, treatment, percutaneous coronary intervention, non-ST-elevation myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Intervention
Arm Type
Active Comparator
Arm Description
Patients with NSTEMI undergo immediate invasive angiography (< 2 hours)
Arm Title
Early Intervention
Arm Type
Active Comparator
Arm Description
Patients with NSTEMI undergo early invasive angiography (12-48 hours)
Arm Title
Selective invasive angiography
Arm Type
Active Comparator
Arm Description
Patients with NSTEMI undergo selective invasive angiography
Intervention Type
Procedure
Intervention Name(s)
Timing of percutaneous coronary intervention
Intervention Description
Immediate, early or selective invasive angiography
Primary Outcome Measure Information:
Title
peak creatine kinase- MB level
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Major bleeding complications (GUSTO definition)
Time Frame
30 days
Title
Composite: death, re-myocardial infarction, recurrent unstable angina
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Links der Weser
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Städt. Klinikum St. Georg
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
University of Leipzig
City
Leipzig
ZIP/Postal Code
12103
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22108830
Citation
Thiele H, Rach J, Klein N, Pfeiffer D, Hartmann A, Hambrecht R, Sick P, Eitel I, Desch S, Schuler G; LIPSIA-NSTEMI Trial Group. Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: the Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial). Eur Heart J. 2012 Aug;33(16):2035-43. doi: 10.1093/eurheartj/ehr418. Epub 2011 Nov 21.
Results Reference
derived
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Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI
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