← Back to Search

Anticoagulant

On-X Aortic Mechanical Valve for Aortic Valve Stenosis

Phase 3

Waitlist Available

Research Sponsored by CryoLife, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether the combination of an On-X aortic valve and the drug apixaban is safe and effective.

Eligible Conditions

Aortic Valve Stenosis
Aortic Valve Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of Valve Thrombosis and Valve-related Thromboembolism

Major Bleeding

Secondary outcome measures

Number of valve-related thrombotic events (superiority)

Secondary Efficacy Objective

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ApixabanExperimental Treatment3 Interventions

Apixaban 5 mg twice daily(BID) or 2.5 mg BID

Group II: WarfarinActive Control2 Interventions

Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apixaban 2.5 MG

2022

Completed Phase 3

~1260

Apixaban 5 MG

2017

Completed Phase 1

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CryoLife, Inc.Lead Sponsor

17 Previous Clinical Trials

1,294 Total Patients Enrolled

2 Trials studying Aortic Valve Stenosis

190 Patients Enrolled for Aortic Valve Stenosis

Duke Clinical Research InstituteOTHER

63 Previous Clinical Trials

240,669 Total Patients Enrolled

Artivion Inc.Lead Sponsor

5 Previous Clinical Trials

474 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project restricted to a few hospitals or is it more widespread?

"enrollees can select from 68 different sites that are currently running this trial. The locations of these sites include Minneapolis, Little Rock and Gainesville among other places. To limit travel, it is best to choose a location nearest you."

Answered by AI

What are the primary conditions that Apixaban 5 MG is used to target?

"Apixaban 5 MG is a common medication used to treat deep vein thrombosis. This drug can also be effective in managing other health concerns such as cerebrovascular accident, systemic embolism, and myocardial infarction."

Answered by AI

Are there any other ongoing studies that use Apixaban 5 MG?

"69 studies are being conducted for Apixaban 5 MG, 23 of which are currently in Phase 3. The main trial site is in Montreal, Quebec, but there are other 1415 locations running similar studies."

Answered by AI