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Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI) (LIPSIA STEMI)

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00359918
First received: August 1, 2006
Last updated: August 6, 2009
Last verified: August 2009
History of Changes
  Purpose

Prehospital initiated facilitation of primary percutaneous coronary intervention by fibrinolysis might be helpful in re-opening the infarct related artery prior to percutaneous coronary intervention.

This studies tests the hypothesis that prehospital initiated facilitated PCI is superior to primary percutaneous coronary intervention with respect to infarct size.


Condition Intervention Phase
Myocardial Infarction
 Drug: fibrinolysis
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Infarct size and microvascular obstruction assessed by MRI [ Time Frame: 1-6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical endpoints (bleeding, death, Re-MI, stroke)
  • ST-segment resolution

Enrollment: 162
Study Start Date: August 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with STEMI with symptoms < 3 hours are randomized in the region of Leipzig to either prehospital full-dose fibrinolysis (+ASA, Clopidogrel and heparin) with subsequent facilitated percutaneous coronary intervention or to primary percutaneous coronary intervention (after ASA + heparin + clopidogrel).

Patients undergo cardiac magnetic resonance for assessment of infarct size early at day 1-4 after randomization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Angina pectoris < 3 hours
  • ST-elevation myocardial infarction

Exclusion Criteria:

  • Active bleeding
  • Active gastric ulcus
  • Previous stroke
  • Uncontrolled hypertension (> 200 mmHg)
  • Cerebral surgery < 8 weeks
  • Major surgery < 4 weeks
  • Malignancy
  • Treatment with coumarines
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359918

Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Holger Thiele, MD, PhD 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: University of Leipzig, Heart Center Leipzig
ClinicalTrials.gov Identifier: NCT00359918     History of Changes
Other Study ID Numbers: Reg.-Nr. 008/2006
Study First Received: August 1, 2006
Last Updated: August 6, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
infarction
facilitated PCI
primary PCI
 infarct size
fibrinolysis
ST-elevation myocardial infarction (STEMI)

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