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

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

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