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Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF

NCT02387229 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1238

Last updated 2025-06-15

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the efficacy and safety of rivaroxaban as compared to standard of care in reducing stroke, transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF and with low risk of stroke.

Conditions

Interventions

DRUG

Rivaroxaban

15 mg

OTHER

standard of care

Sponsors & Collaborators

  • Canadian Stroke Prevention Intervention Network

    collaborator OTHER

  • The Montreal Health Innovations Coordinating Center (MHICC)

    collaborator OTHER

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • Montreal Heart Institute Foundation

    collaborator UNKNOWN

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Hewitt Foundation

    collaborator UNKNOWN

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Lena Rivard, MD · Montreal Heart Institute

  • Sophie Tanguay, M.Sc. · Montreal health Innovations Coordinating Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2024-05-18
Completion
2024-05-18

Countries

  • Canada

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 NCT02387229 on ClinicalTrials.gov