A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants With Moderate Calcific Aortic Valve STenosis
A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants With Moderate Calcific Aortic Valve STenosis
The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.
Key Inclusion Criteria:
Adult male or female at least 50 years of age
Has moderate CAVS as defined by:
Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
For participants in CPET sub-study in Part A and all participants in Part B: If on beta blockade, the dose must be stable for at least 90 days prior to the Screening Visit with no anticipated changes during the study
Key Exclusion Criteria:
clinicaltrials@kardigan.bio1-877-310-5135
Birmingham, Alabama 35233, United States
clinicaltrials@kardigan.bio1-877-310-5135
Pasadena, California 91105, United States
San Francisco, California 94143, United States
Torrance, California 90502, United States
Chicago, Illinois 60611, United States
Elk Grove Village, Illinois 60007, United States
Elkhart, Indiana 46514, United States
Morristown, New Jersey 85831, United States
Greensboro, North Carolina 27401, United States
Cincinnati, Ohio 45219, United States
Lancaster, Pennsylvania 17602, United States
Austin, Texas 78705, United States
Montreal, Quebec H1T 1C8, Canada
Montreal, Quebec H2X 0C1, Canada
clinicaltrials@kardigan.bio1-877-310-5135
clinicaltrials@kardigan.bio1-877-310-5135
clinicaltrials@kardigan.bio1-877-310-5135
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clinicaltrials@kardigan.bio1-877-310-5135
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clinicaltrials@kardigan.bio1-877-310-5135
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clinicaltrials@kardigan.bio1-877-310-5135