ATTRibute-CM Study Design
ATTRibute-CM was a phase III prospective multi-centre, international, randomised, double-blind, placebo-controlled study, evaluating the efficacy and safety of acoramidis versus placebo in individuals with wild-type or variant ATTR-CM.
632 patients were randomised 2:1 to receive either acoramidis hydrochloride 800mg BID or matching placebo for 30 months.
Key Inclusion Criteria:
- 18-90 years with an established diagnosis of ATTR-CM; either wild-type transthyretin or a variant transthyretin genotype
- Clinical heart failure with at least one previous hospitalisation, signs and symptoms of volume overload, or heart failure that resulted in diuretic treatment
- NYHA class I-III symptoms due to ATTR-CM
- On stable doses of cardiovascular medical therapy
Key Exclusions Criteria:
- Confirmed diagnosis of light-chain amyloidosis
Within 90 days prior to screening:
◦ Acute myocardial infarction, acute coronary syndrome, or coronary revascularization
◦ Experienced stroke or transient ischaemia attack
- Haemodynamic instability
- Likely to undergo heart transplantation within a year of screening
- Biomarkers for myocardial wall stress, NT-proBNP level ≥8500 pg/ml at screening
- eGFR by MDRD formula <15 ml/min/1.73 m2
Study Design
* The primary composite efficacy endpoint was analysed using the Finkelstein-Schoenfeld method to compare all potential pairs of patients within strata to generate a p-value.
Finkelstein-Schoenfeld statistical method
ATTRibute-CM baseline characteristics:
Beyonttra was studied in a contemporary population that reflected recent advances in diagnosis and management of ATTR-CM:
Abbreviations:
PP-BEY-IE-0036-1 | November 2025
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professional are asked to report any suspected adverse reactions.