Actively Recruiting
Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-01-07
200
Participants Needed
16
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Treatment history of ATTR-CM is either newly diagnosed with no prior treatment or currently using tafamidis and expected to benefit from switching to acoramidis
- For newly diagnosed participants: history of hospitalization for heart failure or symptoms requiring treatment including diuretics
- For newly diagnosed participants: echocardiographic end-diastolic ventricular septal thickness greater than 12 millimeters
- Confirmed diagnosis of ATTR-CM (wild type or mutant) by tissue biopsy showing amyloid deposition with TTR protein identified or by bone scintigraphy with strong accumulation (Perugini score �3E�3D 2) consistent with myocardium and no M protein to exclude AL amyloidosis
You will not qualify if you...
- Confirmed diagnosis of AL amyloidosis
- Prior treatment with gene silencing agents for ATTR-CM among switch participants
- Likely to receive a heart transplant within 1 year from screening
- Confirmed hypersensitivity to acoramidis or its components
- Pregnant or lactating women
- Any clinically significant medical condition or abnormal lab result that may risk safety or affect study participation
- Participation in another interventional clinical trial
- History of drug abuse, alcoholism, or psychiatric disorder that would prevent compliance with the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Research Site
Bunkyō City, Japan, 113-8431
Not Yet Recruiting
2
Research Site
Bunkyō City, Japan, 113-8603
Not Yet Recruiting
3
Research Site
Kumamoto, Japan, 860-8556
Not Yet Recruiting
4
Research Site
Kurume-shi, Japan, 830-0011
Actively Recruiting
5
Research Site
Kyoto, Japan, 606-8507
Not Yet Recruiting
6
Research Site
Mitaka-shi, Japan, 181-8611
Not Yet Recruiting
7
Research Site
Nagoya, Japan, 466-8560
Not Yet Recruiting
8
Research Site
Nankoku-shi, Japan, 783-8505
Not Yet Recruiting
9
Research Site
Okayama, Japan, 700-8558
Not Yet Recruiting
10
Research Site
Ōtsu, Japan, 520-2192
Not Yet Recruiting
11
Research Site
Sagamihara-shi, Japan, 252-0375
Not Yet Recruiting
12
Research Site
Sapporo, Japan, 060-8543
Not Yet Recruiting
13
Research Site
Shinjuku-ku, Japan, 160-8582
Not Yet Recruiting
14
Research Site
Suita-shi, Japan, 564-8565
Not Yet Recruiting
15
Research Site
Tsu, Japan, 514-8507
Not Yet Recruiting
16
Research Site
Yufu-shi, Japan, 879-5593
Actively Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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