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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
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
November 20, 2006
Last Updated
January 4, 2010
Sponsor
University of Leipzig
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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
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