CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04136171|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2019
Last Update Posted : August 3, 2023
|Condition or disease||Intervention/treatment||Phase|
|Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)||Drug: Eplontersen Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1438 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)|
|Actual Study Start Date :||March 13, 2020|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||November 2025|
Eplontersen by subcutaneous injection once every 4 weeks
Eplontersen by subcutaneous injection
Placebo Comparator: Placebo
Eplontersen-matching placebo by subcutaneous injection once every 4 weeks
Eplontersen-matching placebo by subcutaneous injection
- Composite Outcome of Cardiovascular (CV) Mortality and Recurrent CV Clinical Events up to Week 140 [ Time Frame: Baseline up to Week 140 ]
- Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 121 [ Time Frame: Baseline to Week 121 ]The 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6MWT provides information regarding functional capacity, response to therapy and prognosis across a range of chronic cardiopulmonary conditions.
- Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores at Week 121 [ Time Frame: Baseline to Week 121 ]
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the participant's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period.
The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best, with a higher score equaling a better score.
- CV Clinical Events up to Week 140 [ Time Frame: Baseline up to Week 140 ]
- CV Mortality up to Week 140 [ Time Frame: Baseline up to Week 140 ]
- All-Cause Mortality up to Week 140 [ Time Frame: Baseline up to Week 140 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136171