Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04006288
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2019-06-25
Brief Title:
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Switching From Standard of Care Dual Antiplatelet Treatment DAPT Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition DPI With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease The Switching Anti-Platelet and Anti-Coagulant Therapy SWAP-AC Study
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
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:
SWAP-AC
Brief Summary:
Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations The objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT Patients will be randomized to either maintain DAPT or to DPI DPI consists in treatment with aspirin 81mgqd plus rivaroxaban 25mgbid
Detailed Description:
Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations In the COMPASS trial patients with stable coronary or peripheral artery disease and no indication for oral anticoagulation or dual antiplatelet therapy DAPT were randomized to rivaroxaban 25 mg bid in combination with aspirin rivaroxaban 5 mg bid monotherapy or aspirin monotherapy The study showed a significant 24 relative reduction in ischemic outcomes with rivaroxaban 25 mg bid plus aspirin combination strategy compared with aspirin alone These observations have raised practical considerations on how to implement the results of the COMPASS trial in clinical practice particularly for patients who are completing a minimum duration of DAPT and contemplating between continuing with a DAPT regimen versus switching to a dual pathway inhibition DPI regimen with aspirin plus rivaroxaban Therefore the objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT Patients will be randomized to either maintain DAPT or to DPI DPI consists in treatment with aspirin 81mgqd plus rivaroxaban 25mgbid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None