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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.
Information provided by:
University of Leipzig Identifier:
First received: August 1, 2006
Last updated: August 6, 2009
Last verified: August 2009

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:

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.


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

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
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Please refer to this study by its identifier: NCT00359918

University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
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 Identifier (NCT Number):
Responsible Party: University of Leipzig, Heart Center Leipzig 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:
facilitated PCI
primary PCI
infarct size
ST-elevation myocardial infarction (STEMI)

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on November 25, 2014