ATA-301 (Aortic Valve Stenosis)

Purpose of this Study

We are doing this study to find out if an experimental drug called ataciguant (the study drug) is an effective option to slow the rate of calcium deposits in the aortic valve for people who have aortic stenosis.

Who Can Participate?

Eligibility

Adults ages 50+ who:
  • Are diagnosed with moderate aortic stenosis
  • Have a measured left ventricular ejection fraction of at least 45%
  • Have never had a previous aortic valve replacement, repair, surgery, or intervention and do not anticipate or plan to have an aortic valve replacement in the next 6 months
For more information, contact the study team at hanah.ayoub@duke.edu.

Age Range

50-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No

What is Involved?

Description

if you choose to join this study, you will get a random assignment (like a coin flip) to either:
  • Take the study drug; OR
  • Take a placebo (inactive substance with no medicine in it)
During the study period, you will visit our clinic 12 times for checkups over the course of about 3 years.

Locations

Duke University Hospital
Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Ataciguat to Slow the Progression of Valvular Dysfunction in Participants With Moderate Calcific Aortic Valve Stenosis

Principal Investigator

Anita
Kelsey

Protocol Number

PRO00117504

Phase

III

Enrollment Status

Pending Open to Enrollment