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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)

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ClinicalTrials.gov Identifier: NCT00359918
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Holger Thiele, University of Leipzig

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Myocardial Infarction Drug: fibrinolysis Procedure: Primary PCI Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: Prehospital facilitated PCI Drug: fibrinolysis
Primary PCI
Other Name: Primary PCI
Active Comparator: Primary PCI Procedure: Primary PCI
Primary PCI


Outcome Measures
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Primary Outcome Measures :
  1. Infarct size and microvascular obstruction assessed by MRI [ Time Frame: 1-6 days ]

Secondary Outcome Measures :
  1. Clinical endpoints (bleeding, death, Re-MI, stroke) [ Time Frame: 30 days ]
  2. ST-segment resolution [ Time Frame: 90 min ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359918


Locations
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Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
Holger Thiele
Investigators
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Principal Investigator: Holger Thiele, MD, PhD Heart Center Leipzig - University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Holger Thiele, PI, University of Leipzig
ClinicalTrials.gov Identifier: NCT00359918    
Other Study ID Numbers: Reg.-Nr. 008/2006
First Posted: August 3, 2006    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by Holger Thiele, University of Leipzig:
infarction
facilitated PCI
primary PCI
 infarct size
fibrinolysis
ST-elevation myocardial infarction (STEMI)
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases