Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis (ARCHER)
Acute Myocarditis
About this trial
This is an interventional treatment trial for Acute Myocarditis focused on measuring Pharmaceutically produced CBC, THC < 5ppm
Eligibility Criteria
Inclusion Criteria:
- Males and females aged between 18 and 75 years (inclusive)
- LVEF < 0.50
Diagnosis consistent with acute myocarditis including:
- Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin in the absence of hemodynamically significant CAD* (defined as a stenosis greater than 50% in a major epicardial coronary artery) within the previous 90 days PLUS
- CMR diagnosis: (Lake Louise Criterial) OR
- Endomyocardial biopsy showing either cellular inflammation and/or immunohistochemistry consistent with inflammation
- 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.
- 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 post- menopausal
Exclusion Criteria:
- Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
- Severe valvular heart disease
- Inability to safely undergo CMR including administration of gadolinium
- Estimated glomerular filtration rate (eGFR) < 30 ml/min
- 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.
- Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.
- Severe left ventricular (LV) dysfunction - requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation
- Documented biopsy evidence of giant cell or eosinophilic myocarditis
- Acute coronary syndrome (ACS) within 30 days
- Percutaneous coronary intervention (PCI) within 30 days
- History of QT interval prolongation or QTc interval > 500 msec
- Treated with strong inducers CYP3A4 or CYP2C19
- Current participation in any research study involving investigational drugs or devices
- Inability or unwillingness to give informed consent
- Ongoing drug or alcohol abuse
- Women who are pregnant or breastfeeding
- Current diagnosis of cancer, with the exception of non-melanoma skin cancer
- Any factor, which would make it unlikely that the patient can comply with the study procedures.
- On any cannabinoid during the past month
- Body weight > 170 kg
- Showing suicidal tendency as per the C-SSRS, administered at screening
Sites / Locations
- MedStar Heart and Vascular InstituteRecruiting
- Palm Springs Community Health Centre
- Massachusetts General Hospital siteRecruiting
- Minneapolis Heart Institute FoundationRecruiting
- Cleveland ClinicRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Virginia Commonwealth UniversityRecruiting
- Nupec-OrizontiRecruiting
- PUC trialsRecruiting
- Complexo Hospitalar de NiteróiRecruiting
- Hospital Moinhos de VentoRecruiting
- Hospital de Clínicas de Porto Alegre (HCPA)Recruiting
- Hospital Nove de JulhoRecruiting
- Hospital Felicio Rocho - Fundação Felice RossoRecruiting
- Hospital Angelina CaronRecruiting
- Hospital São LucasRecruiting
- Instituto D´Or de Pesquisa e EnsinoRecruiting
- Hospital Pró-CardíacoRecruiting
- Hospital Regional de São JoséRecruiting
- Irmandade da Santa Casa de Misericórdia de São PauloRecruiting
- Instituto do Coração - InCorRecruiting
- University of Alberta HospitalRecruiting
- McGill University Health CentreRecruiting
- Hopital Louis Pradel Hospices Civils de LyonRecruiting
- CHU de MontpellierRecruiting
- Centre Hospitalier Universitaire de NîmesRecruiting
- Hôpital Lariboisière - Département de CardiologieRecruiting
- Hopital Bichat Claude BernardRecruiting
- Hôpital européen Georges-PompidouRecruiting
- Institut de Cardiologie hopital Pitié SalpêtrièreRecruiting
- Centre Hospitalier Universitaire de PoitiersRecruiting
- Hôpital FochRecruiting
- Chu RangueilRecruiting
- Barzilai Medical CenterRecruiting
- Shaare Zedek Medical CenterRecruiting
- Beilinson Hospital, Rabin medical CenterRecruiting
- Tel Aviv Sourasky Medical Center (Ichilov)Recruiting
- Shamir Medical Center (Assaf Harofeh)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
CardiolRx
Placebo
Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo