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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
Location: See all (59) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
Washington, D.c.
Clinical Trial Site
NOT_YET_RECRUITING
Washington D.c.
Florida
Clinical Trial Site
NOT_YET_RECRUITING
Brandon
Georgia
Clinical Trial Site
RECRUITING
Gainesville
Clinical Trial Site
RECRUITING
Tucker
Massachusetts
Clinical Trial Site
RECRUITING
Boston
Michigan
Clinical Trial Site
NOT_YET_RECRUITING
Detroit
Missouri
Clinical Trial Site
RECRUITING
St Louis
New York
Clinical Trial Site
NOT_YET_RECRUITING
Manhasset
Clinical Trial Site
NOT_YET_RECRUITING
New York
Clinical Trial Site
NOT_YET_RECRUITING
The Bronx
Pennsylvania
Clinical Trial Site
NOT_YET_RECRUITING
Philadelphia
Texas
Clinical Trial Site
NOT_YET_RECRUITING
Dallas
Clinical Trial Site
NOT_YET_RECRUITING
Houston
Other Locations
Argentina
Clinical Trial Site
RECRUITING
Rosario
Australia
Clinical Trial Site
NOT_YET_RECRUITING
Box Hill
Clinical Trial Site
RECRUITING
Joondalup
Austria
Clinical Trial Site
RECRUITING
Braunau Am Inn
Belgium
Clinical Trial Site
NOT_YET_RECRUITING
Roeselare
Brazil
Clinical Trial Site
NOT_YET_RECRUITING
Rio De Janeiro
China
Clinical Trial Site
NOT_YET_RECRUITING
Fuzhou
Clinical Trial Site
NOT_YET_RECRUITING
Guangzhou
Clinical Trial Site
NOT_YET_RECRUITING
Hangzhou
Clinical Trial Site
NOT_YET_RECRUITING
Shanghai
Clinical Trial Site
NOT_YET_RECRUITING
Shenzhen
France
Clinical Trial Site
NOT_YET_RECRUITING
Rouen
Clinical Trial Site
NOT_YET_RECRUITING
Strasbourg
Clinical Trial Site
RECRUITING
Toulouse
Germany
Clinical Trial Site
NOT_YET_RECRUITING
Dresden
Clinical Trial Site
RECRUITING
Leipzig
Israel
Clinical Trial Site
RECRUITING
Be’er Ya‘aqov
Clinical Trial Site
RECRUITING
Petah Tikva
Italy
Clinical Trial Site
NOT_YET_RECRUITING
Ancona
Japan
Clinical Trial Site
NOT_YET_RECRUITING
Fukuoka
Clinical Trial Site
RECRUITING
Fukuoka
Clinical Trial Site
NOT_YET_RECRUITING
Kobe
Clinical Trial Site
NOT_YET_RECRUITING
Nankoku
Clinical Trial Site
NOT_YET_RECRUITING
Okayama
Clinical Trial Site
NOT_YET_RECRUITING
Sapporo
New Zealand
Clinical Trial Site
RECRUITING
Christchurch
Clinical Trial Site
RECRUITING
Hamilton
Norway
Clinical Trial Site
NOT_YET_RECRUITING
Ålesund
Spain
Clinical Trial Site
NOT_YET_RECRUITING
Barcelona
Clinical Trial Site
RECRUITING
Bilbao
Clinical Trial Site
RECRUITING
Huelva
Clinical Trial Site
RECRUITING
Jaén
Clinical Trial Site
RECRUITING
Madrid
Clinical Trial Site
RECRUITING
Palma De Mallorca
Clinical Trial Site
RECRUITING
Pamplona
Clinical Trial Site
RECRUITING
Valencia
Clinical Trial Site
RECRUITING
Valencia
Clinical Trial Site
RECRUITING
Vigo
Switzerland
Clinical Trial Site
RECRUITING
Basel
Clinical Trial Site
NOT_YET_RECRUITING
Bern
Clinical Trial Site
NOT_YET_RECRUITING
Geneva
Clinical Trial Site
RECRUITING
Lucerne
Taiwan
Clinical Trial Site
NOT_YET_RECRUITING
Taichung
United Kingdom
Clinical Trial Site
NOT_YET_RECRUITING
Birmingham
Clinical Trial Site
NOT_YET_RECRUITING
Cardiff
Clinical Trial Site
RECRUITING
Manchester
Contact Information
Primary
Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2032-11-30
Participants
Target number of participants: 1250
Treatments
Placebo_comparator: Placebo
Participants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period.
Experimental: Nucresiran 300 mg
Participants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period.
Related Therapeutic Areas
Sponsors
Leads: Alnylam Pharmaceuticals

This content was sourced from clinicaltrials.gov