NCT00402675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 5, 2010

Status Verified

November 1, 2006

Enrollment Period

3.4 years

First QC Date

November 20, 2006

Last Update Submit

January 4, 2010

Conditions

Myocardial Infarction

Keywords

NSTEMIinfarctiontreatmentpercutaneous coronary interventionnon-ST-elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • peak creatine kinase- MB level

    5 days

Secondary Outcomes (2)

  • Major bleeding complications (GUSTO definition)

    30 days

  • Composite: death, re-myocardial infarction, recurrent unstable angina

    6 months

Study Arms (3)

Immediate Intervention

ACTIVE COMPARATOR

Patients with NSTEMI undergo immediate invasive angiography (\< 2 hours)

Procedure: Timing of percutaneous coronary intervention

Early Intervention

ACTIVE COMPARATOR

Patients with NSTEMI undergo early invasive angiography (12-48 hours)

Procedure: Timing of percutaneous coronary intervention

Selective invasive angiography

ACTIVE COMPARATOR

Patients with NSTEMI undergo selective invasive angiography

Procedure: Timing of percutaneous coronary intervention

Interventions

Timing of percutaneous coronary interventionPROCEDURE

Immediate, early or selective invasive angiography

Early InterventionImmediate InterventionSelective invasive angiography

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinikum Links der Weser

Bremen, 28277, Germany

Location

Städt. Klinikum St. Georg

Leipzig, 04129, Germany

Location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

University of Leipzig

Leipzig, 12103, Germany

Location

Krankenhaus der Barmherzigen Brüder

Regensburg, 93049, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22108830DERIVED

MeSH Terms

Conditions

Myocardial InfarctionNon-ST Elevated Myocardial InfarctionInfarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Holger Thiele

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

January 5, 2010

Record last verified: 2006-11

Locations

DE(5)