Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study

Conditions

• Moderate Aortic Valve Stenosis

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ataciguat — DRUG
  Ataciguat will be administrated daily for up to 156 weeks
• Placebo — DRUG
  Placebo will be administrated daily for up to 156 weeks

Study Details

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

Key Dates

Start date

Jun 27, 2025

Status verified

May 2026

Primary completion

Aug 31, 2028

Completion

Sep 30, 2030

Study Design

Enrollment

1,276 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ataciguat
• Placebo Comparator: Placebo

Primary Outcome Measure

(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24 [ Time Frame: Week 24 ]

Central Contacts

• Kardigan Clinical Trial Information Team
  1-877-310-5135
  [email protected]

Locations (66)

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