Acute ST-segment Elevation Myocardial Infarction Clinical Trial
Official title:
EARLY Routine Catheterization or Rescue Angioplasty After Alteplase Fibrinolysis vs. Primary Angioplasty in Acute ST-elevation MYOcardial Infarction: An Open, Prospective, Randomized, Multicentre Trial
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.
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.
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