Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI) (LIPSIA STEMI)
|ClinicalTrials.gov Identifier: NCT00359918|
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : August 7, 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 or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: fibrinolysis||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|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
- Infarct size and microvascular obstruction assessed by MRI [ Time Frame: 1-6 days ]
- Clinical endpoints (bleeding, death, Re-MI, stroke)
- ST-segment resolution
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||Heartcenter Leipzig GmbH|