Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Conditions
Brief summary
Composite endpoint of CV-death and recurrent CV clinical events comparing the 2 study arms up to Week 140. Cardiovascular clinical events include: 1. Hospitalization for myocardial infarction (MI), Hospitalization for HF, Hospitalization for arrhythmia, Hospitalization for stroke/Transient Ischemic Attack TIA, HF urgent visits to ED/ER or HF clinics requiring administration of intravenous (IV) diuretics for improvement.
Interventions
DRUGPlacebo injection
DRUG0.8 ml (is a sterile
DRUGparenteral solution of sodium chloride and riboflavin in Water for Injection) for subcutaneous administration
DRUGION 682884
Sponsors
Ionis Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of CV-death and recurrent CV clinical events comparing the 2 study arms up to Week 140. Cardiovascular clinical events include: 1. Hospitalization for myocardial infarction (MI), Hospitalization for HF, Hospitalization for arrhythmia, Hospitalization for stroke/Transient Ischemic Attack TIA, HF urgent visits to ED/ER or HF clinics requiring administration of intravenous (IV) diuretics for improvement. | — |
Countries
Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden
Outcome results
None listed