- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01741558
The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial) (TETHYS)
April 5, 2013 updated by: Instituto de Cardiologia do Rio Grande do Sul
The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS: Randomized Double-blind, Placebo-controlled Trial (TETHYS Trial)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniel M. Moreira, MSc.
- Phone Number: 554884175590
- Email: danielmedeirosmoreira@gmail.com
Study Locations
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90620001
- Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
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Contact:
- Daniel M. Moreira, MD. MSc.
- Phone Number: 554884175590
- Email: danielmedeirosmoreira@gmail.com
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Principal Investigator:
- Daniel M. Moreira, MD. MSc.
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Sub-Investigator:
- Carlos AM Gottschall, MD MSc PhD
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Santa Catarina
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São José, Santa Catarina, Brazil, 88103901
- Instituto de Cardiologia de Santa Catarina
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Principal Investigator:
- Daniel M. Moreira, MD. MSc.
-
Contact:
- Daniel M. Moreira, MD. MSc
- Phone Number: 554884175590
- Email: danielmedeirosmoreira@gmail.com
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Sub-Investigator:
- Maria E. Lueneberg, MD.
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Sub-Investigator:
- Roberto L. da Silva, MD.
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Sub-Investigator:
- Tammuz Fattah, MD.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Methotrexate
Established treatment associated with 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
Other Names:
|
PLACEBO_COMPARATOR: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve of creatine kinase
Time Frame: During 72 hours after the infarct
|
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
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During 72 hours after the infarct
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve for creatine kinase MB fraction and troponin I high sensitive
Time Frame: During 72 hours after the infarct
|
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 MB fraction(CK-MB) and Troponin I high sensitive during 72 hours after the infarct
|
During 72 hours after the infarct
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Compare the peaks of CK, CK-MB and troponin I ultra-sensitive
Time Frame: During 72 hours after the infarct
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Compare the peaks of CK, CK-MB and troponin I ultra-sensitive
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During 72 hours after the infarct
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Compare the levels of high-sensitivity C-reactive protein at admission, after 72 hours and after 3 months
Time Frame: After 72 hours and after 3 months
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Compare the levels of high-sensitivity C-reactive at admission, after 72 hours and after 3 months
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After 72 hours and after 3 months
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Compare the levels of erythrocyte sedimentation rate on admission and after 72 hours
Time Frame: On admission and after 72 hours
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Compare the levels of erythrocyte sedimentation rate on admission and after 72 hours
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On admission and after 72 hours
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Compare B-type natriuretic peptide (BNP) levels on admission, after 72 hours and after 3 months
Time Frame: On admission, after 72 hours and after 3 months
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Compare B-type natriuretic peptide (BNP) levels on admission, after 72 hours and after 3 months
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On admission, after 72 hours and after 3 months
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Compare the "TIMI frame count" of the culprit artery
Time Frame: On admission
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Compare the "TIMI frame count" of the culprit artery
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On admission
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Compare the Killip score on admission and after 72 hours
Time Frame: On admission and after 72 hours
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Compare the Killip score on admission and after 72 hours;
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On admission and after 72 hours
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Assess ventricular ejection fraction with transthoracic echocardiography during the first 72 hours after 3 months
Time Frame: During the first 72 hours after 3 months
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Assess ventricular ejection fraction with transthoracic echocardiography during the first 72 hours after 3 months
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During the first 72 hours after 3 months
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Assess mortality at 3 months
Time Frame: At 3 months;
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Assess mortality at 3 months;
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At 3 months;
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Evaluate reinfarction in 3 months
Time Frame: In 3 months
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Evaluate reinfarction in 3 months
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In 3 months
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Rate side effects
Time Frame: In 72 hours
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Evaluation in 72 hours the changes in the levels of hematocrit, hemoglobin, leukocytes and platelets, changes in the levels of serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase and prothrombin Time; changes in the levels of plasma creatinine, gastrointestinal effects (oral ulcers, diarrhea, nausea and vomiting), skin changes (rash, pruritus, and alopecia) and pulmonary effects (pneumonitis and pneumonia).
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In 72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ANTICIPATED)
August 1, 2014
Study Completion (ANTICIPATED)
December 1, 2014
Study Registration Dates
First Submitted
December 3, 2012
First Submitted That Met QC Criteria
December 3, 2012
First Posted (ESTIMATE)
December 5, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 9, 2013
Last Update Submitted That Met QC Criteria
April 5, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Photosensitizing Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Reproductive Control Agents
- Vitamin B Complex
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Riboflavin
Other Study ID Numbers
- UP 4747/12
- CAAE 04482712.3.0000.5333 (OTHER: Plataforma Brasil)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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