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

NCT ID: NCT00359918

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prehospital facilitated PCI

Group Type EXPERIMENTAL

fibrinolysis

Intervention Type DRUG

Primary PCI

Primary PCI

Group Type ACTIVE_COMPARATOR

Primary PCI

Intervention Type PROCEDURE

Primary PCI

Interventions

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fibrinolysis

Primary PCI

Intervention Type DRUG

Primary PCI

Primary PCI

Intervention Type PROCEDURE

Other Intervention Names

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Primary PCI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Holger Thiele

OTHER

Sponsor Role lead

Responsible Party

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Holger Thiele

PI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Holger Thiele, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

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University of Leipzig - Heart Center

Leipzig, , Germany

Site Status

Countries

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Germany

References

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de Waha S, Eitel I, Desch S, Fuernau G, Lurz P, Stiermaier T, Blazek S, Schuler G, Thiele H. Prognosis after ST-elevation myocardial infarction: a study on cardiac magnetic resonance imaging versus clinical routine. Trials. 2014 Jun 25;15:249. doi: 10.1186/1745-6215-15-249.

Reference Type DERIVED
PMID: 24962156 (View on PubMed)

Thiele H, Eitel I, Meinberg C, Desch S, Leuschner A, Pfeiffer D, Hartmann A, Lotze U, Strauss W, Schuler G; LIPSIA-STEMI Trial Group. Randomized comparison of pre-hospital-initiated facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention in acute myocardial infarction very early after symptom onset: the LIPSIA-STEMI trial (Leipzig immediate prehospital facilitated angioplasty in ST-segment myocardial infarction). JACC Cardiovasc Interv. 2011 Jun;4(6):605-14. doi: 10.1016/j.jcin.2011.01.013.

Reference Type DERIVED
PMID: 21700245 (View on PubMed)

Other Identifiers

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Reg.-Nr. 008/2006

Identifier Type: -

Identifier Source: org_study_id

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