Stopped: Due to the COVID-19 pandemic. With a second wave just beginning, and considering that we are testing an immunosuppressant in patients with high risk for COVID-19 complications, we would not be able to re-start recruitment safely in the near future.
Prospective, randomized, double-blind, placebo-controlled, proof of concept study. Patients with first anterior wall STEMI will be randomized with 4±2 days after symptoms beginning to receive ddMTX-LDE at the dose of 40 mg/m2 IV or placebo-LDE weekly for 6 weeks. All study participants will additionally receive folic acid (5 mg po qd) once a week, one day after the study drug. The primary and main secondary endpoints will be analyzed by CMR 3±1 days and at 90±7 days after randomization. Patients will undergo clinical and laboratory safety evaluations before each study drug administration and 90-day post-randomization. Safety evaluations will include assessment of adherence, side effects, safety laboratory tests, and existing medical conditions or planned procedures that might alter study drug dosing. These visits also include screening for the occurrence of clinical events of interest. An algorithm for drug suspension based on clinical and laboratory finding will be followed. Pre-specified unblinded interim analyses by an independent investigator will be developed when 20% and 50% of the inclusions are reached.
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Ventricular Remodelling
Timeframe: 90±7 days