CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Cardiol Therapeutics Inc.
Study ID
NCT06708299
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Pericarditis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CardiolRx — DRUG
    The intervention will be administered orally (via syringe) with food twice daily.

Study Details

Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation. Double-blind treatment will be initiated 10 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks. The objective is to assess whether patients remain free of pericarditis recurrence while receiving CardiolRx.

Key Dates

Start date
Apr 7, 2025
Status verified
Oct 2025
Primary completion
Sep 21, 2026
Completion
Oct 21, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: CardiolRx
    * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight CardiolRx b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight CardiolRx b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight CardiolRx b.i.d.
  • Placebo Comparator: Placebo
    * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight matching placebo b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight matching placebo b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight matching placebo b.i.d.

Primary Outcome Measure

Recurrence of pericarditis [ Time Frame: 24 weeks ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Mayo Clionic ArizonaPhoenixArizona85054
Chadi Ayoub, MD
[email protected]
UCI HealthIrvineCalifornia92697
Amin Sabet, MD
[email protected]
Altman Clinical and Translational Research InstituteLa JollaCalifornia92037
Ajit Raisinghani, MD
[email protected]
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Paul Marano, MD
[email protected]
Pacific Heart Institute at Cedars-SinaiSanta MonicaCalifornia90404
Rigved Tadwalker, MD
[email protected]
Mayo Clinic FloridaJacksonvilleFlorida32224
Prajwal Reddy, MD
[email protected]
Northwestern UniversityChicagoIllinois60208
Mohammed Al-Kazaz, MD
[email protected]
Johns Hopkins UniversityBaltimoreMaryland21205
Luigi Adamo, MD
[email protected]
MedStar Health InstituteColumbiaMaryland21044
Syed Haider, MD
[email protected]
Massachusetts General HospitalBostonMassachusetts02114
Jonathan Salik, MD
[email protected]
Minneapolis Heart InstituteMinneapolisMinnesota55407
David Lin, MD
[email protected]
Mayo ClinicRochesterMinnesota55905
Sushil A Luis, MD
[email protected]
Columbia University - New York PresbyterianNew YorkNew York10032
Dor Lotan, MD
[email protected]
Lenox Hill HospitalNew YorkNew York11030
Dennis Finkielstein, MD
[email protected]
NYU Langone HealthNew YorkNew York10016
Michael Garshick, MD
[email protected]
Cleveland ClinicClevelandOhio44195
Saberio Lo Presti Vega, MD
[email protected]
Houston Methodist HospitalHoustonTexas77030
Maan Malahfji, MD
University of Utah HospitalSalt Lake CityUtah84112
Libo Wang, MD
[email protected]
University of VermontBurlingtonVermont05401
Tracy Hagerty, MD
[email protected]
University of VirginiaCharlottesvilleVirginia22903
Antonio Abbate, MD
[email protected]
Virginia Commonwealth UniversityRichmondVirginia23219
Georgia Thomas, MD
[email protected]

Find similar trials in Phoenix, AZ

By research site
Mayo Clionic Arizona· Phoenix, AZUCI Health· Irvine, CAAltman Clinical and Translational Research Institute· La Jolla, CACedars-Sinai Medical Center· Los Angeles, CAPacific Heart Institute at Cedars-Sinai· Santa Monica, CAMayo Clinic Florida· Jacksonville, FL

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