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

Instituto de Cardiologia do Rio Grande do Sul

Status and phase: Unknown; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: Methotrexate; Drug: Riboflavin

Study type: Interventional

Funder types: Other

Identifiers

NCT01741558

UP 4747/12

CAAE 04482712.3.0000.5333 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Methotrexate

Experimental group

Description:

Established treatment associated with methotrexate

Treatment:

Drug: Methotrexate

Placebo (Riboflavin)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Riboflavin