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

NCT ID: NCT01741558

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-12-31

Brief 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.

Detailed Description

Atherosclerosis and ischemic disease have clear association with inflammation. There is an anti-inflammatory action of methotrexate by increasing adenosine. Experimental studies demonstrate reduction of infarct induced in animals treated with methotrexate. We expect a reduction in the area under the curve of creatine kinase (CK), creatine kinase MB fraction (CK-MB) and Troponin I high sensitive, decreased levels of B-type natriuretic peptide (BNP) and improvement in left ventricular ejection fraction.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methotrexate

Established treatment associated with methotrexate

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

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

Placebo (Riboflavin)

Established treatment associated with placebo (riboflavin sodium fosfate 0.1%). 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.

Group Type: PLACEBO_COMPARATOR

Riboflavin

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Rheumatrex®; Trexall®; Amethopterin; MTX

Eligibility Criteria

Inclusion Criteria

• Age over 18 years;
• Chest pain suggestive of acute myocardial infarction initiated within 12 hours;
• Electrocardiogram with ST-segment elevation greater than or equal to 0.2 mV in at least 2 contiguous leads;
• Choice of primary angioplasty

Exclusion Criteria

• Prior acute myocardial infarction;
• Prior heart failure;
• Angioplasty in the last 3 months;
• Cardiac arrest or cardiogenic shock;
• History of renal insufficiency (serum creatinine greater than 2.0 mg/dl);
• History of alcohol abuse (consumption equal to or greater than 20 drinks per week);
• Illicit drug use;
• Evidence of rheumatoid arthritis;
• Neoplasia;
• Infectious diseases;
• Prior anemia (hematocrit below 30%);
• Use of anti-inflammatory hormonal or non-hormonal last week;
• Xanthines excessive consumption (more than two and a half cups of coffee or two and a half mate gourds);
• Pregnancy;
• Disagreement with the term of consent;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Cardiologia de Santa Catarina

OTHER

Sponsor Role: collaborator

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel M. Moreira, MD. MSc.

Role: STUDY_CHAIR

Instituto de Cardiologia do Rio Grande do Sul

Daniel M. Moreira, MD. MSc

Role: STUDY_DIRECTOR

Instituto de Cardiologia do Rio Grande do Sul

Daniel M. Moreira, MD. MSc.

Role: PRINCIPAL_INVESTIGATOR

Instituto de Cardiologia do Rio Grande do Sul

Carlos AM Gottschall, MD MSc PhD

Role: STUDY_DIRECTOR

Instituto de Cardiologia do Rio Grande do Sul

Maria E. Lueneberg, MD.

Role: STUDY_DIRECTOR

Instituto de Cardiologia de Santa Catarina

Roberto L. da Silva, MD.

Role: STUDY_DIRECTOR

Instituto de Cardiologia de Santa Catarina

Tammuz Fattah, MD.

Role: STUDY_DIRECTOR

Instituto de Cardiologia de Santa Catarina

Locations

Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, Brazil

Countries

Brazil

Central Contacts

Daniel M. Moreira, MSc.

Role: CONTACT

danielmedeirosmoreira@gmail.com

554884175590

Facility Contacts

Daniel M. Moreira, MD. MSc.

Role: primary

danielmedeirosmoreira@gmail.com

554884175590

Daniel M. Moreira, MD. MSc

Role: primary

danielmedeirosmoreira@gmail.com

554884175590

References

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.

Reference Type: DERIVED

PMID: 28325070 (View on PubMed)

Other Identifiers

CAAE 04482712.3.0000.5333

Identifier Type: OTHER

Identifier Source: secondary_id

UP 4747/12

Identifier Type: -

Identifier Source: org_study_id