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Completed

NCT Number: NCT00359918

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

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fibrinolysis

Drug

Primary PCI

Other names: Primary PCI

Primary PCI

Procedure

Primary PCI

Primary outcomes

  1. Infarct size and microvascular obstruction assessed by MRI

    Time frame: 1-6 days

Secondary outcomes

  1. Clinical endpoints (bleeding, death, Re-MI, stroke)

    Time frame: 30 days

  2. ST-segment resolution

    Time frame: 90 min

Sponsors and collaborators

Lead sponsor

Holger Thiele

Other

Registry information

Official study title

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

Acronym: LIPSIA STEMI

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 3, 2006
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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