CardiolRx for Myocarditis

(ARCHER Trial)

No longer recruiting at 47 trial locations

Overseen By Andrea B Parker, MSc, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cardiol Therapeutics Inc.

Must not be taking: Cannabinoids, Digoxin, Antiarrhythmics

Disqualifiers: Coronary artery disease, Severe valvular heart disease, Sepsis, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores CardiolRx, a cannabidiol-based treatment, to determine its effectiveness for myocarditis, a condition characterized by inflammation of the heart muscle. Participants will receive either CardiolRx or a placebo (a substance with no active medicine) for 12 weeks to compare effects. Researchers will use heart imaging and other tests to assess the treatment's impact on heart health and inflammation. The trial seeks individuals recently diagnosed with myocarditis who experience symptoms like chest pain or difficulty breathing. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications to join the trial. Specifically, you cannot participate if you are taking strong inducers of CYP3A4 or CYP2C19, digoxin, or type 1 or 3 antiarrhythmics. If you are on any of these, you would need to stop them before joining.

Is there any evidence suggesting that CardiolRx is likely to be safe for humans?

Research has shown that CardiolRx, a treatment made from cannabidiol, has been safe and well-tolerated in past studies. In trials for conditions like recurrent pericarditis, patients experienced few side effects, indicating general tolerability. CardiolRx does not contain THC, the component of cannabis that causes a high, which may help reduce side effects. While the results are promising, discussing any concerns with a healthcare provider before joining a clinical trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CardiolRx for myocarditis because it leverages cannabidiol, a compound known for its potential anti-inflammatory and cardioprotective properties. Unlike standard treatments that mainly focus on managing symptoms with immunosuppressive drugs or steroids, CardiolRx targets the underlying inflammation directly. This new approach could not only improve heart function more effectively but also reduce the side effects associated with long-term use of current therapies.

What evidence suggests that CardiolRx might be an effective treatment for myocarditis?

Research shows that CardiolRx might help treat myocarditis. Earlier studies found that CardiolRx improved heart function and reduced inflammation. This treatment also helped prevent the heart muscle from thickening and scarring. Patients in these studies tolerated CardiolRx well, with no major safety issues reported. In this trial, participants will receive either CardiolRx or a placebo. These findings suggest that CardiolRx could aid heart healing and reduce inflammation in people with myocarditis. ^{1 2 5 6 7}

Who Is on the Research Team?

Dennis McNamara, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults diagnosed with acute myocarditis, confirmed by clinical symptoms and CMR or biopsy, can join this trial. Participants must agree to use contraception if necessary. Excluded are those with severe heart issues, recent heart procedures, drug/alcohol abuse, pregnant/breastfeeding women, certain other medical conditions or treatments.

Inclusion Criteria

I am using birth control or am post-menopausal.

I have been diagnosed with acute myocarditis, confirmed by specific heart tests or biopsy.

I am a man who will use double barrier contraception or have had a vasectomy.

Exclusion Criteria

I am not currently taking medication that strongly affects certain liver enzymes.

You have a history of a prolonged QT interval or a QTc interval longer than 500 milliseconds.

I need help for my heart to pump blood, like a device or medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive CardiolRx or placebo for 12 weeks with dose escalation from 2.5 mg/kg to 10 mg/kg b.i.d.

12 weeks

Weekly visits for dose adjustment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CardiolRx

Trial Overview The trial is testing CardiolRx (a THC-free Cannabidiol) against a placebo in patients with myocarditis over a period of 12 weeks. It's double-blind and randomized: neither doctors nor patients know who gets the real medicine. They'll check heart health using scans and various tests.

How Is the Trial Designed?

Group I: CardiolRx Experimental Treatment 1 Intervention

* 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

Group II: Placebo Placebo Group 1 Intervention

* 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

Who Is Running the Clinical Trial?

Cardiol Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

330+

Citations

1. cardiolrx.com cardiolrx.com/cardiol-therapeutics-announces-topline-results-from-the-phase-ii-archer-trial-of-cardiolrx-in-acute-myocarditis/

Cardiol Therapeutics Announces Topline Results from the ... Consistent with findings from Cardiol's Phase II MAvERIC trial in recurrent pericarditis, CardiolRx™ was shown to be safe and well tolerated.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05180240

Study Details | NCT05180240 | Impact of CardiolRx on ... The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38937900/

Rationale & design of the ARCHER trial The primary endpoints are defined as changes in global longitudinal strain (GLS) and extra cellular volume (ECV), measured by CMR at 12 weeks. Assuming 80% ...

4. cardiolrx.com cardiolrx.com/cardiol-therapeutics-achieves-target-patient-enrollment-in-its-phase-ii-archer-trial-investigating-cardiolrx-for-acute-myocarditis/

Cardiol Therapeutics Achieves Target Patient Enrollment in ... Additional efficacy outcome measurements include survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change ...

5. myocarditisfoundation.org myocarditisfoundation.org/cardiol-therapeutics-announces-study-results/

Cardiol Therapeutics Announces Study Results Cardiol demonstrated Cardiol Rx improved cardiac function, reduced Inflammatory state, and prevented development of hypertrophy and fibrosis.

6. cardiolrx.com cardiolrx.com/cardiol-therapeutics-announces-year-end-2024-update-on-operations/

Cardiol Therapeutics Announces Year-End 2024 Update ... Reported positive data from the Phase II MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05180240?term=CARDIOLRX&rank=1

Impact of CardiolRx on Myocardial Recovery in Patients ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...