Acute Myocarditis

 

Impact of CardiolRx™ on Myocardial Recovery in Patients With Acute Myocarditis (ARCHER)

Last Update: July 13, 2023

Multi-national, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery in patients presenting with acute myocarditis

ClinicalTrials.gov Identifier: NCT05180240


All compounds are either investigational or being studied for new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

 

 

Study Description

This is a Phase 2, multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial) to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. Pursuant to the design of the study, eligible participants will be randomized to receive CardiolRx™ or placebo.

 

Condition Acute Myocarditis
Phase Phase 2
Overall Status Recruiting
Number of Participants 100
Gender Male or Female
Age(s) 18 years to 75 years

About the Study Medication

Drug: CardiolRx™ (cannabidiol) oral solution or placebo
A form of cannabidiol oral solution is FDA-approved and indicated for the treatment of seizures associated with certain epilepsy syndromes.

Eligible patients will be randomized to receive CardiolRx™ or placebo. Intervention will be administered orally (via syringe) with food twice daily.

 

 

 

Eligibility Criteria

 

Inclusion Criteria:

  • Males and females 18 years of age or older
    1. Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS
    2. CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR
    3. Endomyocardial biopsy (EMB) 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
  • Prior history of sustained ventricular arrhythmia
  • Acute coronary syndrome within 30 days
  • Percutaneous coronary intervention within 30 days
  • History of QT interval prolongation or QTc interval > 500 msec
  • Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8
  • Treated with digoxin and/or type 1 or 3 antiarrhythmics
  • 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

Study Locations

MedStar Heart and Vascular Institute
Washington, District of Columbia, United States, 20010
Contact: Mark Hofmeyer, Dr.
Mark.Hofmeyer@Medstar.net
Principal Investigator: Mark Hofmeyer, Dr.

Palm Springs Community Health Centre (withdrawn)
Miami Lakes, Florida, United States, 33016

Massachusetts General Hospital site
Boston, Massachusetts, United States, 02114
Contact: Daniel Zlotoff, Dr.
DZLOTOFF@mgh.harvard.edu
Principal Investigator: Daniel Zlotoff, Dr.

Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Contact: David Lin, MD
David.Lin@allina.com
Principal Investigator: David Lin, MD

Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Pavan Bhat, Dr.
bhatp@ccf.org
Principal Investigator: Pavan Bhat, Dr.

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Brittany Palmer, MD
palmerba2@upmc.edu

Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Contact: Roshanak Markley, Dr.
roshanak.markley@vcuhealth.org
Principal Investigator: Roshanak Markley, Dr.

Nupec-Orizonti
Belo Horizonte, Minas Gerais, Brazil, 30210090
Contact: Fernando Neuenschwander
fcn2709@gmail.com

Complexo Hospitalar de Niterói
Niterói, Rio De Janeiro, Brazil, 24020-096
Contact: Aurea Grippa, MD

Hospital Moinhos de Vento
Porto Alegre, RS, Brazil, 90035-001
Contact: Eduardo Dytz
eduardo.almeida@hmv.org.br

Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, RS, Brazil, 90035-003
Contact: Luis Beck da Silva
lbneto@hcpa.edu.br

Hospital Felicio Rocho – Fundação Felice Rosso
Belo Horizonte, Brazil
Contact: Maria da Consolação Vieira Moreira, MD

Hospital Angelina Caron
Campina Grande Do Sul, Brazil
Contact: Dalton Bertolim Precoma, MD
daltonprecoma@gmail.com

Hospital São Lucas
Porto Alegre, Brazil
Contact: Paulo Avancini Caramori, MD
caramori@cardiarte.com.br

Instituto D´Or de Pesquisa e Ensino
Rio de Janeiro, Brazil, 22281-100
Contact: Denilson Campos de Albuquerque

Hospital Pró-Cardíaco
Rio de Janeiro, Brazil
Contact: Marcelo Westerlund Montera, MD
Principal Investigator: Marcelo Westerlund Montera

Hospital Regional de São José
São José, Brazil
Contact: Artur Haddad Herdy, MD
arherdy@cardiosport.com.br

Instituto do Coração – InCor
São Paulo, Brazil
Contact: Edimar Bocchi, MD
dcledimar@incor.usp.br

University of Alberta Hospital
Edmonton, Alberta, Canada, T6G2B7
Contact: Justin Ezekowitz, Dr.
jae2@ualberta.ca
Principal Investigator: Justin Ezekowitz, Dr.

McGill University Health Centre
Montréal, Quebec, Canada, H4A 3J1
Contact: Matthias Friedrich, Dr.
matthias.friedrich@mcgill.ca
Principal Investigator

CHU de Montpellier
Montpellier, France, 34295
Contact: François ROUBILLE, MD

Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
Contact: Benoit LATTUCA

Hopital Bichat Claude Bernard
Paris, France
Contact: Jeremie Abtan, MD

Hôpital européen Georges-Pompidou (Not yet recruiting)
Paris, France
Contact: Etienne Puymirat, MD

Institut de Cardiologie hopital Pitié Salpêtrière
Paris, France
Contact: Mathieu Kerneis, MD

Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Contact: Claire BOULETI, MD

Hôpital Foch
Suresnes, France, 92150
Contact: Florent HUANG, MD

Chu Rangueil
Toulouse, France
Contact: Clément Delmas, MD

Barzilai Medical Center
Ashkelon, Israel, 7830604
Contact: Xavier Alejandro Piltz, Dr.
piltzx@bmc.gov.il
Principal Investigator: Xavier Alejandro Piltz, Dr.

Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Contact: Tal Hasin, Prof.
hasint@szmc.org.il
Principal Investigator: Tal Hasin, Prof.

Beilinson Hospital, Rabin medical Center
Petah Tikva, Israel, 4941492
Contact: Alon Eisen, Prof.
Alonei1@clalit.org.il
Principal Investigator: Alon Eisen, Prof.

Tel Aviv Sourasky Medical Center (Ichilov)
Tel Aviv, Israel, 6423906
Contact: Yaron Arbel, Prof.
yarona@tlvmc.gov.il
Principal Investigator: Yaron Arbel, Prof.

Shamir Medical Center (Assaf Harofeh)
Zrifin, Israel, 70300
Contact: Gil Moravsky, Dr.
gmoravsky@shamir.gov.il
Principal Investigator: Gil Moravsky, Dr.

 

Cardiol Therapeutics Inc.

Andrea B Parker, PhD
Phone: +1 289 910 0862
Email: andrea.parker@cardiolrx.com

Andrew Hamer, MD
Email: andrew.hamer@cardiolrx.com

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