At a glance
ClinicalIndex Comparison RecordN/ACompleted· 977 enrolled
Drug / intervention
On-X valve using reduced anticoagulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)
In Brief
A clinical study evaluating On-X valve using reduced anticoagulation and On-X Valve with Standard warfarin Therapy for Heart Valve Disease. Completed, enrolled 977 participants across 49 sites in 2 countries.
Detailed Summary
Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Valve Disease
CountriesCanada, United States
CollaboratorsClinipace Worldwide, Acelis Connected Health, WCG IRB, Avania
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2006
Enrollment StartJun 2006
Primary CompletionAug 2023
Study CompletionDec 2023
TodayJul 2026
First PostedFeb 14, 2006
Enrollment StartJun 6, 2006
Primary CompletionAug 8, 2023
Study CompletionDec 29, 2023
TodayJul 2, 2026
Enrollment to primary: 17.2 yearsPosted 20.4 years ago
Interventions
On-X valve using reduced anticoagulationdevice
Valve replacement with antiplatelet agents or lowered warfarin
On-X Valve with Standard warfarin Therapydevice
Valve replacement with standard dosage warfarin