Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03718429
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2018-10-19
Brief Title:
Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pharmacodynamic Effects of Low-dose Rivaroxaban in Combination With Antiplatelet Therapies in Patients With Coronary and Peripheral Artery Disease Manifestations
Status:
COMPLETED
Status Verified Date:
2022-05
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:
None
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
To date there is very little data and not conducted in human subjects on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies and in particular how this affects profiles of platelet reactivity and thrombin generation Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations including coronary artery disease CAD and peripheral arterial disease PAD the study team proposes a prospective pharmacodynamic PD investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice
To date there is very little data and not conducted in human subjects on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies and in particular how this affects profiles of platelet reactivity and thrombin generation Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations including coronary artery disease CAD and peripheral arterial disease PAD the study team proposes a prospective pharmacodynamic PD investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice
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
However although the introduction of newer antithrombotic strategies has been associated with a reduction in ischemic recurrences in high-risk patients these have been consistently associated with an increase in bleeding complications These have been observed particularly with the combination of an oral anticoagulant agent including low-dose rivaroxaban with standard DAPT also known as triple therapy Observations from laboratory and clinical studies suggest that in the presence of effective blockade of other pathways triggering thrombotic complications aspirin may not offer added antithrombotic effects but contribute to the increased bleeding These observations have set the basis for a large number of clinical outcomes studies evaluating whether dropping aspirin in the presence of more potent and effective blockade of other pathways triggering thrombosis has a better safety profile without a tradeoff in efficacy Amongst these strategies the use of low-dose rivaroxaban in adjunct to a P2Y12 inhibitor also known as dual therapy has been proposed This approach may be of potential benefit to reduce atherothrombotic complications in high-risk patients following an acute coronary event On the other hand regimens with more modest antithrombotic effects compared with a combination of low-dose rivaroxaban and a P2Y12 receptor inhibitor such as low-dose rivaroxaban alone or in combination with aspirin may be more suitable in more stabilized patients
To date there is very little data and not conducted in human subjects on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies and in particular how this affects profiles of platelet reactivity and thrombin generation Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations including coronary artery disease CAD and peripheral arterial disease PAD the study team proposes a prospective pharmacodynamic PD investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice
However although the introduction of newer antithrombotic strategies has been associated with a reduction in ischemic recurrences in high-risk patients these have been consistently associated with an increase in bleeding complications These have been observed particularly with the combination of an oral anticoagulant agent including low-dose rivaroxaban with standard DAPT also known as triple therapy Observations from laboratory and clinical studies suggest that in the presence of effective blockade of other pathways triggering thrombotic complications aspirin may not offer added antithrombotic effects but contribute to the increased bleeding These observations have set the basis for a large number of clinical outcomes studies evaluating whether dropping aspirin in the presence of more potent and effective blockade of other pathways triggering thrombosis has a better safety profile without a tradeoff in efficacy Amongst these strategies the use of low-dose rivaroxaban in adjunct to a P2Y12 inhibitor also known as dual therapy has been proposed This approach may be of potential benefit to reduce atherothrombotic complications in high-risk patients following an acute coronary event On the other hand regimens with more modest antithrombotic effects compared with a combination of low-dose rivaroxaban and a P2Y12 receptor inhibitor such as low-dose rivaroxaban alone or in combination with aspirin may be more suitable in more stabilized patients
To date there is very little data and not conducted in human subjects on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies and in particular how this affects profiles of platelet reactivity and thrombin generation Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations including coronary artery disease CAD and peripheral arterial disease PAD the study team proposes a prospective pharmacodynamic PD investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20180155 | OTHER | WIRB | None |