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

Myocardial Infarction Clinical Trial

— LIPSIA STEMI  

Official title:

Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359918
• Other study ID #: Reg.-Nr. 008/2006
• Status: Completed
• Phase: Phase 4
• Start date: August 2006
• Est. completion date: August 2009

Study information

• Verified date: June 2018
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• fibrinolysis
Primary PCI

Procedure:
• Primary PCI
Primary PCI

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Holger Thiele

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size and microvascular obstruction assessed by MRI		1-6 days
Secondary	Clinical endpoints (bleeding, death, Re-MI, stroke)		30 days
Secondary	ST-segment resolution		90 min