NCT04142658

PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 863 (actual)
• Sponsor: Artivion Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.

Detailed description

There is an unmet clinical need for an alternative to warfarin, such as a direct oral anticoagulant (DOAC), as anticoagulation in participants with an aortic mechanical prosthetic valve. Some participants may be genetically hyper- or hypo-responsive to warfarin, which makes management difficult. Another small group of participants is allergic to warfarin. A much larger group of participants has difficulty maintaining warfarin control due to dietary and drug interactions. Finally, the requirement for routine blood testing makes people reluctant to take warfarin. All of these factors drive younger participants in need of aortic valve replacement (AVR) toward selection of a tissue valve instead of a mechanical valve. Despite multiple studies (randomized, matched and risk adjusted) that show that tissue valves are associated with worse outcomes, younger participants choose this type of valve to avoid warfarin. In addition, multiple clinical studies have shown valve reoperation rates are higher for tissue valves used in these younger participants. Providing an alternative to warfarin anticoagulation may lead younger participants to choose a mechanical valve with greater durability and better clinical outcomes.

Conditions

• Aortic Valve Disease
• Aortic Valve Stenosis
• Aortic Valve Failure

Interventions

Type	Name	Description
DRUG	Apixaban 5 MG	For patients that do NOT meet the following criteria * age ≥ 80 years * weight ≤ 60 kilograms * creatinine ≥ 1.5 mg/dL (133 micromol/L)
DRUG	Apixaban 2.5 MG	For patients that meet at least 2 of the following criteria * age ≥ 80 years * weight ≤ 60 kilograms * creatinine ≥ 1.5 mg/dL (133 micromol/L)
DRUG	Warfarin	Active Control Intervention
DEVICE	On-X Aortic Mechanical Valve	Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2019-10-29
• Last updated: 2024-03-20
• Results posted: 2024-03-20

Locations

62 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study