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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Prehospital facilitated PCI||
Other Name: Primary PCI
|Active Comparator: Primary PCI||
Procedure: Primary PCI
- Infarct size and microvascular obstruction assessed by MRI [ Time Frame: 1-6 days ]
- Clinical endpoints (bleeding, death, Re-MI, stroke) [ Time Frame: 30 days ]
- ST-segment resolution [ Time Frame: 90 min ]
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
|University of Leipzig - Heart Center|
|Leipzig, Germany, 04289|
|Principal Investigator:||Holger Thiele, MD, PhD||Heart Center Leipzig - University Hospital|