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TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

NCT07052903

RecruitingPhase 3

Sponsor: Alnylam Pharmaceuticals

Conditions: Transthyretin Amyloidosis With Cardiomyopathy

Interventions: Nucresiran, Sterile Normal Saline (0.9% NaCl)

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

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

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (251)
  • La Jolla, California, United States
  • Laguna Hills, California, United States
  • Stanford, California, United States
  • Norwich, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Brandon, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Gainesville, Georgia, United States
  • Tucker, Georgia, United States
  • Chicago, Illinois, United States
  • Evanston, Illinois, United States
  • Indianapolis, Indiana, United States
  • Indianapolis, Indiana, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • + 221 more on CT.gov