Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 6:29 AM
Study NCT ID:
NCT05487950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-28
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
SHORT RUN AF
Brief Summary:
The primary objective of the Short Run AF study is to evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of major bleeding events.
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
Detailed Description:
Patients with atrial fibrillation (AF) (\> 30 consecutive seconds of arrhythmia) and high risk embolism meaning CHA2DS2VASC score ≥2 are candidate for long term oral anticoagulation. In addition, patients with excessive supraventricular ectopies or short atrial runs (ESVEA) but no documented AF are also at higher risk of systemic embolism compared to normal population. ESVEA is a frequent clinical situation observed approximately in up to 15% on systematic 24-hour Holter ECG in patients over 65 years old with cardiovascular risk factors. In addition, it is associated with a higher risk of peripheral arterial thromboembolism. However, it remains unclear if this former population could benefit from long-term oral anticoagulation.
To date no other studies have evaluated the effect of anticoagulation for patients with excessive atrial ectopies or short atrial runs. Also, to our knowledge, no study evaluating this problematic is ongoing. This population is actually not treated but in real clinical practice, patients with high CHA2DS2VASC score presenting with ESVEA could be candidate for oral anticoagulation. If it is demonstrated that patients with ESVEA and CHA2DS2VASC score ≥ 3 could benefit from oral anticoagulation and particularly new oral anticoagulants, it would change the everyday practice of cardiologist or gerontologist.
Our hypothesis is that long term anticoagulation with rivaroxaban could reduce drastically (50%, comparable with its effect during AF) the incidence of stroke or other thromboembolism events compared to standard of care (SOC), with a possible but moderate increased risk of bleeding compared to SOC that should remain acceptable compared to the reduction of stroke (net clinical benefit).
In this study, the study also attempt to describe the clinical course of patients with ESVEA in terms of global cardiovascular events, occurrence of documented atrial fibrillation or cognitive decline with an everyday practice follow-up.
To date no other studies have evaluated the effect of anticoagulation for patients with excessive atrial ectopies or short atrial runs. Also, to our knowledge, no study evaluating this problematic is ongoing. This population is actually not treated but in real clinical practice, patients with high CHA2DS2VASC score presenting with ESVEA could be candidate for oral anticoagulation. If it is demonstrated that patients with ESVEA and CHA2DS2VASC score ≥ 3 could benefit from oral anticoagulation and particularly new oral anticoagulants, it would change the everyday practice of cardiologist or gerontologist.
Our hypothesis is that long term anticoagulation with rivaroxaban could reduce drastically (50%, comparable with its effect during AF) the incidence of stroke or other thromboembolism events compared to standard of care (SOC), with a possible but moderate increased risk of bleeding compared to SOC that should remain acceptable compared to the reduction of stroke (net clinical benefit).
In this study, the study also attempt to describe the clinical course of patients with ESVEA in terms of global cardiovascular events, occurrence of documented atrial fibrillation or cognitive decline with an everyday practice follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: