MedTrace Logo

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

NCT01741558 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-04-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methotrexate

The treatment group will receive a bolus dose of 0.05 mg/kg of methotrexate before primary angioplasty followed by 0.05 mg/kg per hour for 6 hours

DRUG

Riboflavin

We use riboflavin in placebo group to remain the double-blind fashion: methotrexate has a yellow color and riboflavin in that concentration has the same color.

Sponsors & Collaborators

  • Instituto de Cardiologia de Santa Catarina

    collaborator OTHER

  • Instituto de Cardiologia do Rio Grande do Sul

    lead OTHER

Principal Investigators

  • Daniel M. Moreira, MD. MSc. · Instituto de Cardiologia do Rio Grande do Sul

  • Daniel M. Moreira, MD. MSc · Instituto de Cardiologia do Rio Grande do Sul

  • Daniel M. Moreira, MD. MSc. · Instituto de Cardiologia do Rio Grande do Sul

  • Carlos AM Gottschall, MD MSc PhD · Instituto de Cardiologia do Rio Grande do Sul

  • Maria E. Lueneberg, MD. · Instituto de Cardiologia de Santa Catarina

  • Roberto L. da Silva, MD. · Instituto de Cardiologia de Santa Catarina

  • Tammuz Fattah, MD. · Instituto de Cardiologia de Santa Catarina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01741558 on ClinicalTrials.gov