Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291525
Status:
UNKNOWN
Last Update Posted:
2022-09-14
First Post:
2006-02-10
Brief Title:
Randomized On-X Anticoagulation Trial
Sponsor:
On-X Life Technologies Inc
Organization:
On-X Life Technologies Inc
Study Overview
Official Title:
Prospective Randomized On-X Anticoagulation Clinical Trial PROACT
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROACT
Brief Summary:
Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinnerCoumadin or on antiplatelet drugs aspirinPlavix only rather than the standard dose of Coumadin and aspirin presently recommended by ACCAHA or ACCP professional societies
Detailed Description:
This is a longitudinal randomized randomization to occur at the 3-month follow-up study comparing the On-X valve on low dose anticoagulation test group to concomitant control groups of On-X valves receiving standard Coumadinaspirin therapy and also to FDA objective performance criteria OPC for heart valve replacement It is a multicenter study consisting of up to 50 centers in the United States Canada and Italy enrolling and randomizing no more than 1200 patients 200 in each of 6 groups There are three test arms of the study low risk aortic valve replacement high risk aortic valve replacement and mitral valve replacement Each arm has an equivalent control Test therapies are low risk aortic valve replacement - aspirinPlavix high risk aortic valve replacement - Coumadin at INR of 15 to 20 plus aspirin and mitral valve replacement - Coumadin at an INR of 20 to 25 plus aspirin Follow-up will run for up to 8 years in each patient Each arm is independent and the low risk aortic and high risk aortic arms are completed The low risk aortic arm was closed early resulting in a reduction of the estimated total enrollment with randomization to 1000 The high risk arm is completed with FDA review and this arm had 375 randomized enrollees The mitral arm continues to enroll with a planned randomized enrollment of 400
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| G050208 | OTHER | FDA | None |