Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976685
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-07-27
Brief Title:
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic StrokE Despite Anticoagulation Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ELAPSE
Brief Summary:
Atrial fibrillation AF is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication Direct oral anticoagulants DOAC reduce the risk of cardioembolism in patients with AF Despite DOAC therapy there is a significant residual stroke risk of 1-2year Recent data from the Swiss Stroke Registry found 38 of patients with AF and ischemic stroke were on prior anticoagulant therapy approximately 400 patients per year in Switzerland The investigators found in a prior observational study that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke HR 16 95 confidence interval CI 11-21 Combining observational data from 11 international stroke centres the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is breakthrough cardioembolism 76 of patients and only a minority of 24 is related to other causes unrelated to AF Optimal secondary prevention strategy is unknown The investigators have conducted two independent observational studies including together 4000 patients but did not identify any strategy eg switch to different DOAC additional antiplatelet therapy that seems superior A recent randomized controlled trial on surgical occlusion of the left atrial appendage LAAO found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation Triggered by this finding the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy DOAC therapy LAAO had lower rates of adverse outcomes compared to those with DOAC therapy alone Therefore the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone The investigators propose an international multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology The investigators will use the PROBE design with blinded endpoint assessment The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset Patients will be randomized 11 to receive LAAO DOAC therapy experimental arm or DOAC therapy alone standard treatment arm The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke systemic embolism and cardiovascular death during follow-up Secondary outcomes include individual components of the primary composite outcome safety outcomes ie symptomatic intracranial haemorrhage major extracranial bleeding serious device- or procedure-related complication functional outcome modified Rankin Scale and patient-oriented outcomes The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study the maximal follow-up will be 48 months Based on prior observational data from the investigators group and others 5 observational studies 5000 patients the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18 in the first year and 9 in the second year cumulative 27 after 2 years A relative risk reduction of 40 at 2 years would be clinically relevant Based on these assumptions and a log-rank test the investigators would need 98 events for a power of 80 at an alpha-level of 5 Assuming a recruitment rate of 52 118 156 and 156 patients in years 1 to 4 an additional 6 months of follow-up mean follow-up time of 21 years and a uniform drop-out rate of 75 per year 482 patients would need to be enrolled How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation
Detailed Description:
None
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