Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-14
Brief Title:
Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
SPICAF
Brief Summary:
Patients who have recently had an ischemic stroke with no clear cause might have undetected atrial fibrillation AF that isnt caught during their initial hospital stay After discharge these patients are typically monitored for AF using devices like Holter monitors or implantable loop recorders Treatment options during this period include anticoagulants or aspirin Anticoagulants are more effective in preventing recurrent strokes if AF is present offering an 80 risk reduction compared to aspirins 20 If AF is detected anticoagulant treatment continues if not patients may switch to aspirin after 6-12 months Despite the clinical rationale for using anticoagulants during this search period their benefit-risk ratio compared to aspirin has not been fully evaluated
Detailed Description:
Patients with recent ischemic stroke with an unknown cause may have a clinical radiological and echocardiographic pattern of covert atrial fibrillation which is yet undetected by history ECG monitoring or telemetry during the initial hospital stay These patients are usually discharged with a prescription of detection of atrial fibrillation in the next weeks by either Holter ECG monitoring or loop recorder such as wearing device or implantable device Current standard treatment for these patients is either using anticoagulant treatment during the time of atrial fibrillation search or simply aspirin with the risk that the patient has an undetected paroxysmal atrial fibrillation with a high risk of recurrent stroke that is less prevented by aspirin 20 RRR than by anticoagulant 80 RRR Anticoagulant treatment in this situation is clinically justified by the fact that if the patient actually has an atrial fibrillation an anticoagulant treatment during the search period of AF will protect the patient from a recurrent stroke rather than treating the patient after the discovery of AF with the risk that an AF-related recurrent stroke occurs in-between Anticoagulant treatment is then continued if atrial fibrillation is demonstrated by monitory devices or is stopped with a switch to aspirin after 6-12 months of negative AF search since investigators know after NAVIGATE-ESUS and RESPECT-ESUS trials that long-term aspirin is safer and as effective as anticoagulant in case of cryptogenic stroke
Although anticoagulant treatment during the search period for AF makes clinically sense and is widely used in clinical practice its benefitrisk ratio compared to aspirin therapy has not been evaluated
Although anticoagulant treatment during the search period for AF makes clinically sense and is widely used in clinical practice its benefitrisk ratio compared to aspirin therapy has not been evaluated
Study Oversight
Has Oversight DMC:
None
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?:
None