CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
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|ClinicalTrials.gov Identifier: NCT04136171|
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : September 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)||Drug: AKCEA-TTR-LRx Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 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 :||January 2024|
|Estimated Study Completion Date :||June 2024|
ACKEA-TTR-LRx by subcutaneous injection once every 4 weeks
ACKEA-TTR-LRx by subcutaneous injection
Other Name: ION-682884
Placebo Comparator: Placebo
Matching placebo by subcutaneous injection once every 4 weeks
Matching placebo by subcutaneous injection
- Composite Outcome of Cardiovascular (CV) Mortality and recurrent CV clinical events at Week 120 [ Time Frame: Baseline to Week 120 ]
- Change From Baseline in the 6MWT Distance at Week 120 [ Time Frame: Baseline to Week 120 ]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 120 [ Time Frame: Baseline to Week 120 ]
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient'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 Mortality at Week 120 [ Time Frame: Baseline to Week 120 ]
- Rate of CV Clinical Events at Week 120 [ Time Frame: Baseline to Week 120 ]
- Rate of All-Cause Mortality at Week 120 [ Time Frame: Baseline to Week 120 ]
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
|Contact: Ionis Pharmaceuticals||(844) 413-0219||ionisNCT04136171study@clinicaltrialmedia.com|