Acoramidis (AG10) oral tablet: Study drug is defined as acoramidis 712 mg (equivalent to 800 mg acoramidis hydrochloride) taken orally twice daily for 36 months of open label treatment.
Study summary
The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria:
* Participants aged 18 to 80
* Confirmed diagnosis of ATTR-CM requiring targeted therapy
* At screening: New York Heart Association (NYHA) Class I/II; estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73m2; left ventricular ejection fraction (LVEF) \>35%; left ventricular (LV) wall thickness ≥12 mm.
* Heart failure condition has been clinically stable for at least 6 weeks prior to screening.
Key Exclusion Criteria:
* Current or planned implantation of a cardiac implantable electronic device (eg, pacemaker, implantable cardiac defibrillator).
* Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.
* Hemodynamic instability.
* Likely to undergo heart transplantation within 12 months from screening.
* Confirmed diagnosis of AL amyloidosis at screening.
* At screening: NYHA Class III/IV; National Amyloidosis Center (NAC) Stage 3.
* Prior or current treatment with acoramidis.
Primary outcome measure(s)
To assess the effect of acoramidis on cardiac function improvement by CMR in participants with ATTR-CM. — Month 36 Change from baseline in left ventricular ejection fraction (LVEF) or left ventricular stroke volume index (LVSVi) at Month 36.
Trial sites (1)
Facility
City
Region
Status
Washington University in St. Louis
St Louis
Missouri
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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