EARLY Routine Catheterization After Alteplase Fibrinolysis vs. PPCI in ST-Segment-Elevation MYOcardial Infarction
Condition: Acute ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The EARLY-MYO (EARLY routine catheterization after alteplase fibrinolysis vs. primary PCI in
      acute ST-segment elevation MYOcardial infarction) is an investigator-initiated, prospective,
      multicenter, randomized (1:1), open-label, actively-controlled, parallel group,
      non-inferiority trial comparing the efficacy and safety of a PhI strategy with half-dose
      fibrinolysis versus PPCI in STEMI patients presenting within 6 hours after symptom onset and
      with an expected PCI-related delay of ≥60 min.
    

Detailed description: 
      Early, successful restoration of myocardial perfusion after a ST-elevation myocardial
      infarction (STEMI) is the most effective way to reduce final infarct size and improve
      clinical outcome. Reperfusion for STEMI treatment in the modern era encompasses mechanical
      and pharmacological strategies. It is generally well-accepted that primary percutaneous
      coronary intervention (PPCI) is the preferred reperfusion strategy for all STEMI patients
      when it can be performed within the guideline-recommended timeframe at PPCI-capable
      facilities. However, PPCI is not universally available, and delays in performing percutaneous
      coronary intervention (PCI) are common in real-world practice. Even in some large cities,
      patients have a high chance of presenting to hospitals not providing around-the-clock PPCI
      service. Given this background, in recent years there has been great interest and progress in
      creating triage strategies for STEMI patients who cannot receive timely PPCI.

      Pharmaco-invasive (PhI) strategy, an early reperfusion strategy by initial prompt
      fibrinolysis with subsequent early catheterization (with either routine early PCI after
      successful fibrinolysis or rescue PCI as needed), has been proposed as a therapeutic option
      for STEMI patients when timely PPCI is not feasible. However, current evidence on the
      efficacy and safety of PhI strategy in STEMI patients is limited, and the role of PhI
      strategy in STEMI continues to be debated. Given that no randomized clinical trial is
      available to compare a PhI strategy with half-dose fibrinolytic regimen versus PPCI in STEMI
      patients, investigators plan to perform a controlled, randomized trial to evaluate the
      efficacy and safety of a PhI strategy with half-dose alteplase fibrinolysis versus PPCI in
      STEMI patients.
    

Intervention name(s): Alteplase; Early post-fibrinolytic catheterisation; Primary PCI
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Alteplase is given as a intravenous bolus (8-mg) followed by 42 mg iv gtt in 90 min.; Early post-fibrinolytic catheterisation after 3 hours but within 24 hours of the start of fibrinolytic therapy is performed, if required, PCI or, in case of insufficient ST resolution at 90 min,rescue PCI. The decision on rescue PCI will, however, be taken 90 min (or earlier if clinically indicated) after injection of alteplase according to the ST resolution (less than 50% reduction in ST-segment elevation).; For STEMI Patients,primary PCI is performed within 12 hours after the onset.
Other intervention name(s): rt-PA
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial Infarction; Catheterization; Fibrinolysis