NCT03516903

Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After STEMI

Terminated Phase 2, PHASE3 Last updated 11 January 2021

What this trial tests

Phase 2, PHASE3 trial testing Methotrexate in Myocardial Infarction, Anterior Wall in 35 participants. Terminated before completion.

Timeline

17 April 2018

Primary endpoint
17 December 2020

17 December 2020

Quick facts

Lead sponsor	University of Sao Paulo
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	35
Start date	17 April 2018
Primary completion	17 December 2020
Estimated completion	17 December 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Methotrexate — full drug profile →
• Placebo
• Folic Acid (FOLIC ACID) — full drug profile →

Conditions studied

• Myocardial Infarction, Anterior Wall — all drugs for Myocardial Infarction, Anterior Wall →
• Myocardial Remodeling, Ventricular — all drugs for Myocardial Remodeling, Ventricular →

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 75, any sex, with Myocardial Infarction, Anterior Wall or Myocardial Remodeling, Ventricular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoparticles in the diagnosis and treatment of vascular aging and related diseases.
   Xu H, Li S, Liu YS. · · 2022 · cited 52× · PMID 35817770 · DOI 10.1038/s41392-022-01082-z
2. Benefits and adverse effects of hydroxychloroquine, methotrexate and colchicine: searching for repurposable drug candidates.
   Misra DP, Gasparyan AY, Zimba O. · · 2020 · cited 43× · PMID 32880032 · DOI 10.1007/s00296-020-04694-2
3. Nanocarrier-Based Targeted Therapies for Myocardial Infarction.
   George TA, Hsu CC, Meeson A, Lundy DJ. · · 2022 · cited 28× · PMID 35631516 · DOI 10.3390/pharmaceutics14050930
4. Repurposing existing drugs for cardiovascular risk management: a focus on methotrexate.
   Mangoni AA, Tommasi S, Zinellu A, Sotgia S, et al · · 2018 · cited 19× · PMID 30459819 · DOI 10.7573/dic.212557