Contemporary characteristics and treatment effect of Acoramidis on caRdiac biomarkErs in patients with transthyretin amyloid cardiomyopathy trial (CARE-ATTR trial);

Contemporary characteristics and treatment effect of Acoramidis on caRdiac biomarkErs in patients with transthyretin amyloid cardiomyopathy trial (CARE-ATTR trial); - Real world effect of acoramidis on cardiac biomarkers in ATTR-CM

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071250063

Enrollment

200

Registered

2025-09-02

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin amyloid cardiomyopathy (ATTR-CM) Amyloidosis, Transthyretin, amyloid cardiomyopathy

Interventions

Acoramidis 800mg BID

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ATTR-positive biopsy and/or 99mTc scan Naive: Newly diagnosed ATTR-CM not previously treated Switch: Patients with diagnosed ATTR-CM (wt)/variant and treated with stabilizers, or tafamidis

Exclusion criteria

Exclusion criteria: Patients treated with ATTR silencers

Design outcomes

Primary

Measure	Time frame
Prevalence of disease progression, as determined by changes in NT-proBNP levels and/or diuretic intensification at 12 months ; definition of disease progression is: NT-proBNP progression: >700 pg/mL and 30% increase in NT-proBNP ODI: Diuretics other than MRAs started or increased after baseline (furosemide conversion performed for loop diuretics)	—

Secondary

Measure	Time frame
Association between change in serum TTR levels at one month and the following indexes at 12 months/18 months: - 30% change (increase/decrease) of NT-proBNP at 12 months and 18 months - Change of Troponin T (hs-cTnT) at 12 months and 18 months - Change of KCCQ at 12 months and 18 months - Change of eGFR at 12 months and 18 months	—

Contacts

Public ContactNorihiko Kondo

Alexion Pharma GK

JPDept-DevOps-PMCO@alexion.com+81-3-3457-9559

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026