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Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

NCT01938248 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4012

Last updated 2023-11-15

No results posted yet for this study

Summary

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.

Conditions

Interventions

DRUG

Apixaban

apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age \> 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)

DRUG

aspirin

aspirin 81 mg once daily

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Jeff Healey, M.D. · Population Health Research Institute

  • Stuart Connolly, M.D. · Population Health Research Institute

  • Marco Alings, M.D. · Working Group Cardiovascular Research Netherlands

  • Renato Lopes, M.D. · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2023-10-27
Completion
2023-11-03

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01938248 on ClinicalTrials.gov