The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS: Randomized Double-blind, Placebo-controlled Trial (TETHYS Trial)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Area under the curve of creatine kinase
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
研究组 & 干预措施
Methotrexate
Established treatment associated with methotrexate
干预措施: Methotrexate (Drug)
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.
干预措施: Riboflavin (Drug)
结局指标
主要结局
Area under the curve of creatine kinase
时间窗: 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
次要结局
- 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)
- Compare the "TIMI frame count" of the culprit artery(On admission)
- Compare the Killip score on admission and after 72 hours(On admission and after 72 hours)
- Assess ventricular ejection fraction with transthoracic echocardiography during the first 72 hours after 3 months(During the first 72 hours after 3 months)
- Assess mortality at 3 months(At 3 months;)
- Evaluate reinfarction in 3 months(In 3 months)
- Rate side effects(In 72 hours)