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TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)
Status: Recruiting
The purpose of this research study is to test whether nucresiran is safe and helps people with transthyretin amyloidosis (ATTR) with cardiomyopathy. In this study, the effects of nucresiran are compared to the effects of placebo. At the beginning of this study, each person will have a 2 out of 3 (67%) chance of being placed in the nucresiran group.
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• Adults age 18-85 years old at the time of screening.
• Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy.
• Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis).
• Screening NT-proBNP >300ng/L; in patients with permanent or persistent atrial fibrillation, Screening NT-proBNP >600 ng/L and <8500 ng/L.
Exclusion Criteria:
• Has known primary amyloidosis (AL amyloidosis) or leptomengeal amyloidosis
• Has a polyneuropathy disability requiring a cane or stick to walk or is wheelchair bound
• Received prior or currently receiving TTR-lowering therapy (eg, revusiran, patisiran, inotersen, eplontersen, or vutrisiran or gene therapy targeting TTR)
• Prior or anticipated (during the first 12 months after randomization) heart, liver, or other organ transplant or implantation of LVAD
• Has untreated hypo- or hyperthyroidism
• Had acute coronary syndrom or unstable angina within the past 3 months
Interventions:
Drug/Device: nucresiran
Conditions:
Transthyretin amyloidosis with cardiomyopathy
Keywords:
ATTR, cardiac amyloidosis
Contact(s): Jodi Carter - GeneralCardiologyResearch@hfhs.org
Principal Investigator: Karthikeyan Ananthasubramaniam
Principal Investigator ID: kananth1@hfhs.org
Phase: III
See this study on ClinicalTrials.gov