EUCTR2021-006637-19-FR进行中（未招募）1 期
Impact of CardiolRxTM on Myocardial Recovery in Patients with Acute MyocarditisA double-blind, placebo-controlled trial (ARCHER) - ARCHER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females 18 years of age or older
- •2. Diagnosed with acute myocarditis including:
- •a) Clinical criteria (symptoms of chest pain, arrhythmia or shortness of
- •breath, or history of viral-like illness), preferably followed by elevated
- •troponin PLUS
- •b) CMR diagnosis (Lake Louise Criteria) within 10 days prior to
- •randomization OR
- •c) Endomyocardial biopsy (EMB) showing either cellular inflammation
- •and/or immunohistochemistry consistent with inflammation.
- •3. Male subjects with partners of childbearing potential who have had a
- •vasectomy or are willing to use double barrier contraception methods
- •during the conduct of the study and for 2 months after the last dose of
- •study drug.
- •4. Women of childbearing potential willing to use an acceptable method
- •of contraception starting with study drug administration and for a
- •minimum of 2 months after study completion. Otherwise, women must
- •be postmenopausal (at least 1 year absence of vaginal bleeding or
- •spotting and confirmed by follicle stimulating hormone [FSH] =40
- •mIU/mL [or = 40 IU/L] if less than 2 y postmenopausal) or be surgically
- •sterile. The following reliable methods of contraception are: parenteral
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Coronary artery disease (CAD) defined as a stenosis greater than
- •50% in a major epicardial coronary artery
- •2. Severe valvular heart disease
- •3. Inability to safely undergo CMR including administration of
- •4. Estimated glomerular filtration rate (eGFR) < 30 ml/min
- •5. Elevated alanine aminotransferase (ALT) or aspartate
- •aminotransferase (AST) > 5 times the upper limit of normal (ULN)
- •or ALT or AST >3x ULN plus bilirubin >2x ULN.
- •6. Sepsis, defined as documented bacteremia at the time of
- •presentation or other documented active infection.
- •7. Severe left ventricular (LV) dysfunction - requiring inotropic
- •support, left ventricular assist device (LVAD) or other circulatory
- •assist devices, or urgent need for transplantation
- •8. Documented biopsy evidence of giant cell or eosinophilic
- •myocarditis
研究者
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