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

What's the purpose of this trial?

The purpose of this study is to evaluate the efficacy of nucresiran.

This trial is currently open and accepting patients.


What will happen during the trial?

  • 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

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 3

Enrollment: 1,750 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Stanford University Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting

Florida

Florida Cancer Specialists - North - Brandon

Brandon, FL

Open and Accepting

Miami VA Medical Center

Miami, FL

Open and Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Maryland

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Massachusetts

Boston Children's Hospital

Boston, MA

Open and Accepting

Boston Medical Center

Boston, MA

Open and Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

North Shore University Hospital

Manhasset, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Open and Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Pennsylvania

Ann B. Barshinger Cancer Institute - Lancaster General Health Penn Medicine

Lancaster, PA

Open and Accepting

South Carolina

MUSC Hollings Cancer Center Medical University of South Carolina

Charleston, SC

Open and Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Inova Fairfax Medical Hospital Inova Schar Cancer Institute

Falls Church, VA

Open and Accepting

Massey Cancer Center Virginia Commonwealth University (VCU Health)

Richmond, VA

Open and Accepting

Washington

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, WA

Open and Accepting
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