Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAlexion Pharmaceuticals, Inc.
About this trial
The purpose of this study is to confirm that the treatment with acoramidis prevents the deterioration of the ATTR-CM disease progression index and that these indexes are surrogate markers of disease progression.
Eligibility criteria
Qualifiers
Naive participants: newly diagnosed with ATTR-CM and no prior treatment with drugs for ATTR-CM
Switch participants: Participants who are using tafamidis, a TTR stabilizer, as treatment for ATTR-CM and who, in the judgment of the post-marketing clinical trial investigator (co-principal investigator), can be expected to benefit from switching to acoramidis.
History of hospitalization for heart failure or heart failure symptoms requiring treatment, including diuretics
Echocardiographic end-diastolic ventricular septal thickness greater than 12 millimeters (mm)
Disqualifiers
Have confirmed diagnosis of AL amyloidosis
Switch participants: prior treatment with gene silencing agents (pachysilane sodium, butrisilane sodium) as treatment for ATTR-CM (including when specifically scheduled to start treatment with a gene silencing agent)
Likelihood of receiving a heart transplant within 1 year from the time screening begins
Hypersensitivity to acoramidis, its metabolites, or additives in the formulation has been confirmed.
Trial design
Treatments tested in this trial
- Acoramidis
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov