The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)

Phase 2 Unknown 80 enrolled Instituto de Cardiologia do Rio Grande do Sul Instituto de Cardiologia de Santa Catarina · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce the inflammatory profile in acute ischemic disease and reduce the area of ischemia. Methotrexate is a drug that has shown promise in ischemic disease in animal studies.

Timeline

Start: 2013-04
Primary completion: 2014-08
Completion: 2014-12

Outcome

Missed primary endpoint

paper Median AUC of CK was 78 861.0 in the methotrexate group and 68 088.0 in the placebo group ( P = .10). PMID 28325070 ↗

paper Methotrexate did not reduce infarction size PMID 28325070 ↗

Publications

Moreira DM, Lueneberg ME, da Silva RL, Fattah T, Gottschall CAM. MethotrexaTE THerapy in ST-Segment Elevation MYocardial InfarctionS: A Randomized Double-Blind, Placebo-Controlled Trial (TETHYS Trial). J Cardiovasc Pharmacol Ther. 2017 Nov;22(6):538-545. doi: 10.1177/1074248417699884. Epub 2017 Mar 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methotrexate	Small molecule	0.05 mg/kg	—