Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study
NCT ID: NCT07001800
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
1276 participants
INTERVENTIONAL
2025-06-27
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ataciguat
Ataciguat
Ataciguat will be administrated daily for up to 156 weeks
Placebo
Placebo
Placebo will be administrated daily for up to 156 weeks
Interventions
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Ataciguat
Ataciguat will be administrated daily for up to 156 weeks
Placebo
Placebo will be administrated daily for up to 156 weeks
Eligibility Criteria
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Inclusion Criteria
2. Has moderate CAVS as defined by:
1. An AVA of ≥1.0 cm2 to ≤1.50 cm2
2. An AVC score between ≥600 to 1200 Agatston units (AU) for women and between ≥600 to 2000 AU for men
3. Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
4. For participants 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
Exclusion Criteria
2. Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
3. Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
4. Has suspected or known congenital aortic valve disease including bicuspid aortic valve
5. New York Heart Association (NYHA) Class III or Class IV
6. Has a primary etiology for heart failure other than aortic valve disease
7. Has coronary artery disease or anticipating coronary stenting surgery
8. Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation
50 Years
ALL
No
Sponsors
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Kardigan, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham (UAB) - Medical Center
Birmingham, Alabama, United States
Heart Center Research LLC
Huntsville, Alabama, United States
Onyx Clinical Research - Peoria
Peoria, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Profound Research LLC at Southern California Heart Specialists
Pasadena, California, United States
University of California, San Francisco (UCSF) - Medical Center
San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
HCA Florida - JFK Hospital
Atlantis, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
New Generation of Medical Research - Naples
Naples, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
NorthShore University Health System
Glenview, Illinois, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
St. Vincent Medical Group, Inc.
Carmel, Indiana, United States
University of Iowa Health Care
Iowa City, Iowa, United States
University of Louisville Health
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Corewell Health
Royal Oak, Michigan, United States
Henry Ford Hospital
West Bloomfield, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, United States
Inspira Medical Center of Vineland
Vineland, New Jersey, United States
Albany Medical Center
Albany, New York, United States
University of Buffalo
Buffalo, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University School of Medicine
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, United States
Sanford Fargo
Fargo, North Dakota, United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ascension St. John Jane Phillips Hospital
Bartlesville, Oklahoma, United States
Ascension St. John Hospital
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
OnSite Clinical Solutions, LLC - Rock Hill
Rock Hill, South Carolina, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Ascension Saint Thomas Heart Midtown
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
St. David's Heart and Vascular dba Austin Heart - Main Office
Austin, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, Texas, United States
Methodist Hospital - San Antonio
San Antonio, Texas, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States
University of Utah Hospital & Clinics
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Kardigan Clinical Study Information Team Kardigan Clinical Study Information Team
Role: primary
Other Identifiers
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ATA-301
Identifier Type: -
Identifier Source: org_study_id
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