Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI) (LIPSIA STEMI)
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.
|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|
- Infarct size and microvascular obstruction assessed by MRI [ Time Frame: 1-6 days ] [ Designated as safety issue: No ]
- Clinical endpoints (bleeding, death, Re-MI, stroke)
- ST-segment resolution
|Study Start Date:||August 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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.