TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nucresiran, Sterile Normal Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Transthyretin Amyloidosis With Cardiomyopathy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +30
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
The purpose of this study is to: * Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events * Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death * Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Interventions
- Drug Nucresiran
Nucresiran 300 mg administered SC q6M - Drug Sterile Normal Saline (0.9% NaCl)
Sterile Normal Saline (0.9% NaCl) administered SC once q6M
Primary outcome measures
- Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits) [Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)]
Secondary outcome measures (4)
- Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality [Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)]
- All-cause mortality [Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)]
- Recurrent CV events (CV hospitalizations and urgent HF visits) [Time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)]
- Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) [Time frame: Baseline to Month 30]
Eligibility criteria
Inclusion criteria
- Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis.
- Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic.
- Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) >300 ng/L and <8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP >600 ng/L and <8500 ng/L.
- Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator.
Exclusion criteria
- Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3.
- Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV.
- Has an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m\^2 at screening.
- Has received prior or currently receiving TTR-lowering therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 40 centers
- Clinical Trial Site — La Jolla
- Clinical Trial Site — Stanford
- Clinical Trial Site — Norwich
- Clinical Trial Site — Washington D.C.
- Clinical Trial Site — Brandon
- Clinical Trial Site — Miami
- Clinical Trial Site — Atlanta
- Clinical Trial Site — Gainesville
- … and 32 more centers
Japan · 18 centers
Center list to be confirmed — check the primary protocol.
Spain · 18 centers
Center list to be confirmed — check the primary protocol.
France · 16 centers
Center list to be confirmed — check the primary protocol.
Italy · 15 centers
Center list to be confirmed — check the primary protocol.
Germany · 11 centers
Center list to be confirmed — check the primary protocol.
Belgium · 10 centers
- Clinical Trial Site — Aalst
- Clinical Trial Site — Bruges
- Clinical Trial Site — Brussels
- Clinical Trial Site — Dendermonde
- Clinical Trial Site — Genk
- Clinical Trial Site — Ghent
- Clinical Trial Site — Hasselt
- Clinical Trial Site — Leuven
- … and 2 more centers
Brazil · 9 centers
- Clinical Trial Site — Belo Horizonte
- Clinical Trial Site — Porto Alegre
- Clinical Trial Site — Porto Alegre
- Clinical Trial Site — Ribeirão Preto
- Clinical Trial Site — Ribeirão Preto
- Clinical Trial Site — Rio de Janeiro
- Clinical Trial Site — Salvador
- … and 2 more centers
Argentina · 8 centers
- Clinical Trial Site — Buenos Aires
- Clinical Trial Site — Buenos Aires
- Clinical Trial Site — Buenos Aires
- Clinical Trial Site — Buenos Aires
- Clinical Trial Site — Córdoba
- Clinical Trial Site — Rosario
- Clinical Trial Site — Rosario
- Clinical Trial Site — Rosario
Australia · 8 centers
- Clinical Trial Site — Adelaide
- Clinical Trial Site — Bedford Park
- Clinical Trial Site — Box Hill
- Clinical Trial Site — Chermside
- Clinical Trial Site — Darlinghurst
- Clinical Trial Site — Joondalup
- Clinical Trial Site — Liverpool
- Clinical Trial Site — Westmead
Austria · 7 centers
- Clinical Trial Site — Braunau am Inn
- Clinical Trial Site — Graz
- Clinical Trial Site — Vienna
- Clinical Trial Site — Vienna
- Clinical Trial Site — Vienna
- Clinical Trial Site — Vienna
- Clinical Trial Site — Wels
China · 7 centers
Center list to be confirmed — check the primary protocol.
Portugal · 7 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 6 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 5 centers
Center list to be confirmed — check the primary protocol.
South Korea · 5 centers
Center list to be confirmed — check the primary protocol.
Czechia · 4 centers
Center list to be confirmed — check the primary protocol.
Greece · 4 centers
Center list to be confirmed — check the primary protocol.
Israel · 4 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Canada · 3 centers
Center list to be confirmed — check the primary protocol.
Denmark · 3 centers
Center list to be confirmed — check the primary protocol.
New Zealand · 3 centers
Center list to be confirmed — check the primary protocol.
Sweden · 3 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 3 centers
Center list to be confirmed — check the primary protocol.
Chile · 2 centers
Center list to be confirmed — check the primary protocol.
Hungary · 2 centers
Center list to be confirmed — check the primary protocol.
Ireland · 2 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 2 centers
Center list to be confirmed — check the primary protocol.
Norway · 2 centers
Center list to be confirmed — check the primary protocol.
Romania · 2 centers
Center list to be confirmed — check the primary protocol.
Hong Kong · 1 center
Center list to be confirmed — check the primary protocol.
Poland · 1 center
Center list to be confirmed — check the primary protocol.
Slovakia · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07052903 · ALN-TTRSC04-003 · 2024-519917-72-00