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Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes

NCT02618577 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2608

Last updated 2025-02-06

Study results available
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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.

Conditions

  • Atrial High Rate Episodes

Interventions

DRUG

Edoxaban

Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF

DRUG

ASA

ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripheral or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Sponsors & Collaborators

  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

    collaborator INDUSTRY

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • Atrial Fibrillation Network

    lead OTHER

Principal Investigators

  • Paulus Kirchhof, Prof. Dr. · University Clinic of Hamburg-Eppendorf, Hamburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02618577 on ClinicalTrials.gov