Ignite Creation Date:
2024-05-06 @ 7:51 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02618577
Status:
TERMINATED
Last Update Posted:
2023-07-28
First Post:
2015-11-27
Brief Title:
Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes
Sponsor:
Atrial Fibrillation Network
Organization:
Atrial Fibrillation Network
Study Overview
Official Title:
Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes - An Investigator-driven Prospective Randomised Double-blind Multi-centre Trial Initiated by the European Society of Cardiology and AFNET
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
following a recommendation from the data safety and monitoring board due to safety concerns and a tendency towards futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOAH
Brief Summary:
NOAH is an investigator-initiated prospective parallel-group double-blind randomised multi-centre trial The objective of the trial is to demonstrate that oral anticoagulation using the NOAC edoxaban is superior to current therapy to pre-vent stroke systemic embolism or cardiovascular death in patients with AHRE and at least two stroke risk factors but without AF The trial will be conducted in several European countries
Detailed Description:
Atrial fibrillation AF is a common cause of stroke especially ischemic stroke So far all available data that demonstrate a beneficial effect of oral anticoagulation for stroke prevention have been collected in populations with AF documented by conventional ECG recordings It is well established that a large proportion of AF episodes remain undiagnosed silent AF and many of these patients present with a stroke as the first clinical sign of AF Earlier initiation of anticoagulation could prevent such events Continuous monitoring of atrial rhythm by implanted devices could close this diagnostic gap Pacemakers defibrillators and cardiac resynchronisation devices already provide automated algorithms alerting to the occurrence of highly organised atrial tachyarrhythmia episodes also called subclinical atrial fibrillation or more commonly atrial high rate episodes AHRE Data from large prospectively followed patient cohorts demonstrated that stroke rate is increased in patients with AHRE A sizeable portion of these patients develops clinically detected AF over time In these patients AHRE can be considered as an early manifestation of paroxysmal AF A few AHRE patients do not develop clinically overt AF and the absolute stroke rates are lower in patients with AHRE when compared to stroke rates in patients with clinically diagnosed AF In light of the bleeding complications associated with oral anticoagulant therapy there is thus uncertainty about the optimal antithrombotic therapy in patients with AHREs
The Non-vitamin K antagonist Oral anticoagulants NOACs provide similar or slightly better stroke prevention and appear slightly safer compared to vitamin K antagonists VKAs In addition no individual therapy adjustment of NOACs has to be performed Edoxaban a newly introduced NOAC at a dose regime of 60 mg once daily OD has a favourable profile compared to dose-adjusted VKA therapy In the ENGAGE-TIMI 48 trial edoxaban prevented strokes at least as effectively as VKA therapy but caused less major bleeding events than VKA therapy
The Non-vitamin K antagonist Oral anticoagulants NOACs provide similar or slightly better stroke prevention and appear slightly safer compared to vitamin K antagonists VKAs In addition no individual therapy adjustment of NOACs has to be performed Edoxaban a newly introduced NOAC at a dose regime of 60 mg once daily OD has a favourable profile compared to dose-adjusted VKA therapy In the ENGAGE-TIMI 48 trial edoxaban prevented strokes at least as effectively as VKA therapy but caused less major bleeding events than VKA therapy
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-003997-33 | EUDRACT_NUMBER | None | None |