Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03148457
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2017-04-07
Brief Title:
Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN ELAN an International Multicentre Randomised-controlled Two-arm Assessor-blinded Trial
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN ELAN an International Multicentre Randomised-controlled Two-arm Assessor-blinded Trial
Status:
COMPLETED
Status Verified Date:
2023-07
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:
ELAN
Brief Summary:
When to start anticoagulation in patients with an acute ischaemic stroke and atrial fibrillation AF is a relevant unanswered question in clinical practice Direct oral anticoagulants DOACs are highly effective for secondary stroke prevention in these patients but DOACs were never initiated 7 days after stroke onset in recent trials The ELAN trial will determine the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF
The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF
The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation
The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF
The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation
Detailed Description:
Background Atrial fibrillation AF is the most common cardiac arrhythmia increasing the risk of stroke and systemic thromboembolism and thus mortality and morbidity Anticoagulation therapy such as with vitamin K antagonists effectively prevents strokes in patients with AF however increases bleeding complications leading to symptomatic intracerebral haemorrhage Direct oral anticoagulants DOACs are at least as effective as vitamin K antagonists in preventing recurrent strokes but with lower rates of symptomatic intracerebral haemorrhage Therefore these new agents are potentially ideal drugs to treat patients with ischaemic stroke related to AF However in previous trials comparing DOACs with vitamin K antagonists therapy was initiated later than 7-14 days after onset of ischaemic stroke Whether earlier initiation of DOACs may prevent recurrent stroke without increasing the risk of symptomatic intracerebral haemorrhage remains to be determined
Objectives The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF
The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation
Methods All patients of 18 years or older with an acute ischaemic stroke related to AF should be screened for this trial
Patients in the experimental arm early treatment and the control arm late treatment will receive direct oral anticoagulants for prevention of stroke and systemic embolism in patients with AF Depending on the size of the infarction early treatment will be started within 48 hours after symptom onset minor and moderate ischaemic stroke or at day 6 1 day after symptom onset major ischaemic stroke Patients in the control arm will receive late treatment as per current recommendations ie minor ischaemic stroke after day 3 1 day moderate ischaemic stroke after day 6 1 day and major ischaemic stroke after day 12 2 day
The primary outcome is a composite of major bleeding recurrent ischaemic stroke systemic embolism andor vascular death at 30 3 days after randomisation
Objectives The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF
The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation
Methods All patients of 18 years or older with an acute ischaemic stroke related to AF should be screened for this trial
Patients in the experimental arm early treatment and the control arm late treatment will receive direct oral anticoagulants for prevention of stroke and systemic embolism in patients with AF Depending on the size of the infarction early treatment will be started within 48 hours after symptom onset minor and moderate ischaemic stroke or at day 6 1 day after symptom onset major ischaemic stroke Patients in the control arm will receive late treatment as per current recommendations ie minor ischaemic stroke after day 3 1 day moderate ischaemic stroke after day 6 1 day and major ischaemic stroke after day 12 2 day
The primary outcome is a composite of major bleeding recurrent ischaemic stroke systemic embolism andor vascular death at 30 3 days after randomisation
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?:
False
Is an FDA AA801 Violation?:
None