All > Aortic Stenosis > Madison

Apixaban 5 MG for Aortic Valve Stenosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Aortic Valve Stenosis+5 MoreApixaban 5 MG - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Brensocatib
1
Durvalumab
1
Erythropoietin (EPO)

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 2 years

2 years
Co-Primary Efficacy Objective
Number of major bleeding events (superiority)
Number of valve-related thrombotic events (superiority)
Secondary Efficacy Objective

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Brensocatib
1
Durvalumab
2
Erythropoietin (EPO)

Trial Design

2 Treatment Groups

Warfarin
1 of 2
Apixaban
1 of 2

Active Control

Experimental Treatment

1000 Total Participants · 2 Treatment Groups

Primary Treatment: Apixaban 5 MG · No Placebo Group · Phase 3

ApixabanExperimental Group · 3 Interventions: Apixaban 2.5 MG, Apixaban 5 MG, On-X Aortic Mechanical Valve · Intervention Types: Drug, Drug, Device
WarfarinActiveComparator Group · 2 Interventions: Warfarin, On-X Aortic Mechanical Valve · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved
Apixaban
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

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
57 Previous Clinical Trials
230,317 Total Patients Enrolled
Artivion Inc.Lead Sponsor
5 Previous Clinical Trials
474 Total Patients Enrolled
John Alexander, MDStudy ChairSteering Committee
3 Previous Clinical Trials
4,202 Total Patients Enrolled
Lars Svensson, MD, PhDStudy ChairSteering Committee
2 Previous Clinical Trials
373 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years of age.\n
References

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top