Treatment of Patients With Atherosclerotic Disease With Methotrexate-associated to LDL Like Nanoparticles
Status:
Recruiting
Trial end date:
2023-10-12
Target enrollment:
Participant gender:
Summary
The investigators propose a prospective, randomized, double-blind, placebo-controlled study.
The purpose of the study is to evaluate the safety and efficacy of an anti-inflammatory agent
methotrexate in a cholesterol-rich non-protein nanoparticle (MTX-LDE) in patients with stable
coronary disease.
Patients with multi-vessels stable coronary disease will be randomized to receive MTX-LDE IV
or placebo-LDE IV each 7 days for 12 weeks. The primary and main secondary endpoints will be
analyzed by coronary and aortic CT angiography, that will be performed before the first
treatment cycle, four weeks after the last drug infusion and 12 months after randomization.
Patients will undergo clinical and laboratory safety evaluations before each treatment cycle,
four weeks after the last cycle and 12 months after randomization.
An algorithm for drug suspension based on clinical and laboratory finding will be followed.