Ignite Creation Date:
2025-12-18 @ 8:25 AM
Ignite Modification Date:
2025-12-23 @ 10:58 PM
Study NCT ID:
NCT03192215
Status:
None
Last Update Posted:
2025-04-09 00:00:00
First Post:
2017-06-16 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Sponsor:
None
Organization:
Study Overview
Official Title:
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Status:
None
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The DSMB halted the trial prematurely due to futility without any safety concerns.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCADIA
Brief Summary:
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at up to 200 sites in and out of the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
Detailed Description:
None
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?: