Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI) (LIPSIA STEMI)

Holger Thiele

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Procedure: Primary PCI; Drug: fibrinolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00359918

Reg.-Nr. 008/2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Prehospital facilitated PCI

Experimental group

Treatment:

Drug: fibrinolysis

Primary PCI

Active Comparator group

Treatment:

Procedure: Primary PCI