The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)
TETHYS
2 other identifiers
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 9, 2013
April 1, 2013
1.3 years
December 3, 2012
April 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the curve of creatine kinase
The primary end point was the reduction of the size of the infarct as assessed by the area under the curve (AUC) (expressed in arbitrary units) for creatine kinase (CK) during 72 hours after the infarct
During 72 hours after the infarct
Secondary Outcomes (11)
Area under the curve for creatine kinase MB fraction and troponin I high sensitive
During 72 hours after the infarct
Compare the peaks of CK, CK-MB and troponin I ultra-sensitive
During 72 hours after the infarct
Compare the levels of high-sensitivity C-reactive protein at admission, after 72 hours and after 3 months
After 72 hours and after 3 months
Compare the levels of erythrocyte sedimentation rate on admission and after 72 hours
On admission and after 72 hours
Compare B-type natriuretic peptide (BNP) levels on admission, after 72 hours and after 3 months
On admission, after 72 hours and after 3 months
- +6 more secondary outcomes
Study Arms (2)
Methotrexate
EXPERIMENTALEstablished treatment associated with methotrexate
Placebo (Riboflavin)
PLACEBO COMPARATOREstablished 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620001, Brazil
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, 88103901, Brazil
Related Publications (1)
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.
PMID: 28325070DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daniel M. Moreira, MD. MSc.
Instituto de Cardiologia do Rio Grande do Sul
- STUDY DIRECTOR
Daniel M. Moreira, MD. MSc
Instituto de Cardiologia do Rio Grande do Sul
- PRINCIPAL INVESTIGATOR
Daniel M. Moreira, MD. MSc.
Instituto de Cardiologia do Rio Grande do Sul
- STUDY DIRECTOR
Carlos AM Gottschall, MD MSc PhD
Instituto de Cardiologia do Rio Grande do Sul
- STUDY DIRECTOR
Maria E. Lueneberg, MD.
Instituto de Cardiologia de Santa Catarina
- STUDY DIRECTOR
Roberto L. da Silva, MD.
Instituto de Cardiologia de Santa Catarina
- STUDY DIRECTOR
Tammuz Fattah, MD.
Instituto de Cardiologia de Santa Catarina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 5, 2012
Study Start
April 1, 2013
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
April 9, 2013
Record last verified: 2013-04