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TRITON-CM: A Study to Evaluate Nucresiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy
EU CTIS ID: 2024-519917-72-00
What this study is testing
Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and CV events
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age 18 (or age of legal consent per local regulations, whichever is older) to 85 years, inclusive.
- 2. Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy:
- 3. Medical history of HF with at least 1 prior hospitalization for HF OR clinical evidence of HF (with or without hospitalization)
- 4. Patients may be receiving approved TTR stabilizers for ATTR amyloidosis and may be receiving background therapy for HF but must be stable for at least 30 days prior to screening
- 5. Patient is clinically stable, with no CV-related hospitalizations within 6 weeks prior to randomization
- 6. Screening 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
You likely can't join if
- 1. Has known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis
- 10. Female patient is pregnant, planning a pregnancy, or breastfeeding
- 11. Unwilling or unable to limit alcohol consumption, with a history of alcohol use disorder within the last 12 months, or a history of illicit drug use within the past 5 years that could interfere with study compliance
- 2. NYHA Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3 (defined as NT-proBNP >3000 ng/L and eGFR <45 mL/min)
- 3. Has a polyneuropathy disability Score IIIa, IIIb, or IV at the Screening visit.
- 4. Has any of the following lab parameter at screening: a. AST or ALT levels ˃2.0×ULN; b. Total bilirubin >2.0×ULN; c. INR >1.5 (unless patients were on anticoagulant therapy in which case excluded if INR ˃3.5).
See the full eligibility criteria
Who can join
- 1. Age 18 (or age of legal consent per local regulations, whichever is older) to 85 years, inclusive.
- 2. Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy:
- 3. Medical history of HF with at least 1 prior hospitalization for HF OR clinical evidence of HF (with or without hospitalization)
- 4. Patients may be receiving approved TTR stabilizers for ATTR amyloidosis and may be receiving background therapy for HF but must be stable for at least 30 days prior to screening
- 5. Patient is clinically stable, with no CV-related hospitalizations within 6 weeks prior to randomization
- 6. Screening 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
- 7. Patient is able to understand and is willing and able to comply with the study requirements and to provide written informed consent
What rules you out
- 1. Has known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis
- 10. Female patient is pregnant, planning a pregnancy, or breastfeeding
- 11. Unwilling or unable to limit alcohol consumption, with a history of alcohol use disorder within the last 12 months, or a history of illicit drug use within the past 5 years that could interfere with study compliance
- 2. NYHA Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3 (defined as NT-proBNP >3000 ng/L and eGFR <45 mL/min)
- 3. Has a polyneuropathy disability Score IIIa, IIIb, or IV at the Screening visit.
- 4. Has any of the following lab parameter at screening: a. AST or ALT levels ˃2.0×ULN; b. Total bilirubin >2.0×ULN; c. INR >1.5 (unless patients were on anticoagulant therapy in which case excluded if INR ˃3.5).
- 5. Has an eGFR of <30 mL/min/1.73m2 at screening (calculation will be based on the CKD-EPI equation)
- 6. Has known HIV infection or evidence of current or chronic HCV or HBV infection.
- 7. Patients with current, prior or planning to receive TTR-lowering therapy, anti-TTR antibody treatment, diflunisal, or participating in another investigational study (must meet washout periods of previous treatment to be included).
- 8. Patients with the following medical conditions: • significant non-TTR cardiomyopathies, unstable CHF, recent acute coronary syndrome, ventricular arrhythmias, pacemaker-indicated nodal dysfunction, or uncontrolled high blood pressure are excluded from the study. • untreated hypo- or hyperthyroidism • active infections requiring systemic antiviral, antiparasitic, or antimicrobial therapy that will not be completed before dosing • Prior or anticipated ( 12 months after randomization) organ transplant or implantation of LVAD • multiple drug allergies or history of allergic reaction to any component of study drug • intolerance to SC injection • other medical conditions or comorbidities that could interfere with study compliance or data interpretation, or a life expectancy of <2 years due to any non-cardiovascular condition
- 9. Unwilling to comply with the contraceptive requirements during the study;
The study team makes the final eligibility decision.
Where it's taking place
- Saudi Arabia
- Switzerland
- New Zealand
- Argentina
- Malaysia
- Canada
- Colombia
- Australia
- Taiwan
- Japan
- Israel
- Turkey
- Hong Kong
- Brazil
- Korea, Republic of
- Chile
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saudi Arabia; Switzerland; New Zealand; Argentina; Malaysia; Canada and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.