CTIS2024-514639-10-00招募中1 期
Impact of CardiolRx on Myocardial Recovery in patients with Acute Myocarditis. A double-blind, placebo-controlled trial (ARCHER)” - Cardiol 100-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 年龄范围
- 18 至 65+（—）
- 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, Appendix 17.4 of this protocol) within 10 days prior to randomization OR c). Endomyocardial biopsy 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 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 contraceptives, oral contraceptives, patch contraceptives, implantable hormonal contraceptives, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the subject’s current practice. Periodic abstinence, i.e., calendar, symptothermal, or post-ovulation methods are not an acceptable form of contraception for this study. These methods of contraception also apply to female partners of male subjects.
排除标准
- •1. Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery, 10. Acute coronary syndrome within 30 days, 11. Percutaneous coronary intervention within 30 days, 12. History of QT interval prolongation or QTc interval > 500 msec, 13. Treated with strong inducers CYP3A4 or CYP2C19, as listed in [Protocol] Appendix 17.8, 14. Treated with digoxin and/or type 1 or 3 antiarrhythmics, 15. Current participation in any research study involving investigational drugs or devices, 16. Inability or unwillingness to give informed consent, 17. Ongoing drug or alcohol abuse, 18. Women who are pregnant or breastfeeding, 19. Current diagnosis of cancer, with the exception of non-melanoma skin cancer, 2. Severe valvular heart disease, 20. Any factor, which would make it unlikely that the patient can comply with the study procedures, 21. On any cannabinoid during the past month, 22. Body weight > 170 kg, 23. Showing suicidal tendency as per the C-SSRS, administered at screening, 24. Hypersensitivity to any component of CardiolRxTM (Cannabidiol Oil), 25. Patients under legal protection (protection of the court, or in curatorship or guardianship), 26. Current seizures or history of seizures, 3. Inability to safely undergo CMR including administration of gadolinium, 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, 9. Prior history of sustained ventricular arrhythmia
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