Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After STEMI
Status:
Terminated
Trial end date:
2020-12-17
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo