Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (NOAH)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02618577 |
Recruitment Status :
Terminated
(following a recommendation from the data safety and monitoring board due to safety concerns and a tendency towards futility.)
First Posted : December 1, 2015
Last Update Posted : July 28, 2023
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | November 27, 2015 | |||
First Posted Date ICMJE | December 1, 2015 | |||
Last Update Posted Date | July 28, 2023 | |||
Actual Study Start Date ICMJE | February 2016 | |||
Actual Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
stroke, systemic embolism, or cardiovascular death [ Time Frame: 28 months ] Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death
|
|||
Original Primary Outcome Measures ICMJE |
Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death [ Time Frame: 28 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes | |||
Official Title ICMJE | 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 | |||
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. |
|||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Phase 3b Masking: Double (Participant, Investigator)Primary Purpose: Prevention |
|||
Condition ICMJE | Atrial High Rate Episodes | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
2608 | |||
Original Estimated Enrollment ICMJE |
3400 | |||
Actual Study Completion Date ICMJE | December 31, 2022 | |||
Actual Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
In addition, at least one of the following cardiovascular conditions leading to a modified CHA2DS2VASc score of 2 or more:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 65 Years and older (Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Ukraine, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02618577 | |||
Other Study ID Numbers ICMJE | NOAH - AFNET 6 2015-003997-33 ( EudraCT Number ) |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Atrial Fibrillation Network | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Atrial Fibrillation Network | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
|
|||
Investigators ICMJE |
|
|||
PRS Account | Atrial Fibrillation Network | |||
Verification Date | July 2023 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |