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New treatment option for Moderate Aortic Valve Stenosis
Official title Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
ClinicalTrials.gov ID: NCT07001800
What this study is testing
What is Ataciguat?
Ataciguat is an investigational medicine, given as an once-daily, being studied as a potential treatment for moderate aortic valve stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Adult male or female at least 50 years of age
- Has moderate CAVS as defined by:
- An AVA of ≥1.0 cm2 to ≤1.50 cm2
- An AVC score between \>300 to 1200 Agatston units (AU) for women and between \>300 to 2000 AU for men
- Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
You likely can't join if
- For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's...
- Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
- Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- Has suspected or known congenital aortic valve disease including bicuspid aortic valve
- New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
- Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
See the full eligibility criteria
- Adult male or female at least 50 years of age
- Has moderate CAVS as defined by:
- An AVA of ≥1.0 cm2 to ≤1.50 cm2
- An AVC score between \>300 to 1200 Agatston units (AU) for women and between \>300 to 2000 AU for men
- 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
- For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's opinion, could lead to an inability to complete Protocol-required CPET...
- Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
- Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
- Has suspected or known congenital aortic valve disease including bicuspid aortic valve
- New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
- Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
- Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
- Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Pasadena, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Atlantis, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Saint Augustine, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
+ 47 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States; Phoenix, Arizona, United States; Beverly Hills, California, United States; Los Angeles, California, United States; Newport Beach, California, United States and 61 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.