MedTrace Logo

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress

NCT03968393 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2270

Last updated 2026-01-12

No results posted yet for this study

Summary

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.

Conditions

Interventions

DRUG

Non-vitamin K oral anticoagulant (NOAC)

Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

  • Hamilton Health Sciences Corporation

    collaborator OTHER

Principal Investigators

  • David Conen, MD, MPH · Population Health Research Institute

  • PJ Devereaux, MD, PhD · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Denmark
  • Finland
  • Germany
  • India
  • Italy
  • Nepal
  • Netherlands
  • Pakistan
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03968393 on ClinicalTrials.gov