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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06073587




Registration number
NCT06073587
Ethics application status
Date submitted
4/10/2023
Date registered
10/10/2023
Date last updated
10/10/2023

Titles & IDs
Public title
The CARDIO-TTRansform Scintigraphy Sub-study
Scientific title
CARDIO-TTRansform ION-682884-CS2-Scintigraphy Sub-study
Secondary ID [1] 0 0
2019-002835-27
Secondary ID [2] 0 0
ION-682884-CS2-Scintigraphy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Scintigraphy scan

ION-682884-CS2 Scintigraphy Subset - Participants randomized in ION-682884-CS2 (NCT04136171) study to receive either eplontersen or placebo with baseline scintigraphy scan with planar and single-photon emission computerized tomography (SPECT) or SPECT with computed tomography (SPECT/CT) images will undergo an optional scintigraphy scan at Weeks 25 or 37, Week 97, and an additional scan at Week 140.


Diagnosis / Prognosis: Scintigraphy scan
Scans will be performed as specified in the arm description.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140
Timepoint [1] 0 0
Baseline up to Week 140

Eligibility
Key inclusion criteria
- Participants must have been properly randomized into the ION-682884-CS2 study
(NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP,
and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and
SPECT or SPECT/CT images that can be read by the central reader.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2
(NCT04136171).

- Must not have weight or body girth that exceeds the limits of the equipment
specifications.

- Should not have any previously reported hypersensitivity reaction to Technetium-99m.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
Spain
State/province [5] 0 0
Majadahonda

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ionis Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to examine the changes in amyloid myocardial burden in a subset
of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150
participants, after treatment with eplontersen or placebo based on scintigraphy scans
performed at Week 140 using the Perugini grade score method.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06073587
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries