Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
CARDIO-TTRansform ION-682884-CS2-Scintigraphy Sub-study
Query!
Secondary ID [1]
0
0
2019-002835-27
Query!
Secondary ID [2]
0
0
ION-682884-CS2-Scintigraphy
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
0
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140
Query!
Assessment method [1]
0
0
The Perugini grading scale visually compares tracer uptake in the myocardium and ribs following injection of the bone tracers (99mTc-DPD, 99mTc-Pyrophosphate [PYP], or 99mTc-HMDP). The scale includes 4 grade classifications: Grade 0- no cardiac uptake and normal rib uptake, Grade 1- cardiac uptake which is less than rib uptake, Grade 2- cardiac uptake with intensity similar rib uptake, and Grade 3- cardiac uptake greater than rib uptake with mild or absent rib uptake. Visual scores of 2 or greater are classified as ATTR-positive and less than 2 are interpreted as ATTR-negative.
Query!
Timepoint [1]
0
0
Baseline up to Week 140
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
90
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/04/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/03/2026
Query!
Actual
Query!
Sample size
Target
150
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
New York
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
North Carolina
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Ohio
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Oregon
Query!
Country [5]
0
0
Spain
Query!
State/province [5]
0
0
Majadahonda
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Ionis Pharmaceuticals, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
AstraZeneca
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06073587
Query!
Trial related presentations / publications
Query!
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
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06073587
Download to PDF