Skip to main content
OpenTrials
Completed

NCT Number: NCT02792335

Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients

To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with NVAF who were on warfarin and have switched to the NOACs (dabigatran, rivaroxaban and apixaban) within the study period January 01, 2013 through March 31, 2014
  • Individuals ≥18 years old on the index date
  • At least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date
  • At least 1 diagnosis of AF in the 12 months prior to index date
  • Continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date

Exclusion criteria

  • Individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date

Treatment and study plan

Apixaban

Drug

dabigatran

Drug

Rivaroxaban

Drug

Warfarin

Drug

Primary outcomes

  1. Discontinuation rate of patients with prior warfarin use

    Time frame: up to 31 months

  2. Rate of major bleeding events of patients with prior warfarin use

    Time frame: up to 31 months

  3. Rate of hospitalization due to major bleeding events of patients with warfarin use

    Time frame: up to 31 months

  4. Discontinuation rate of patients who were naïve to oral anticoagulant

    Time frame: up to 31 months

  5. Rate of major bleeding events of patients who were naïve to oral anticoagulant

    Time frame: up to 31 months

  6. Rate of hospitalization due to major bleeding events of patients who were naïve to oral anticoagulant

    Time frame: up to 31 months

Secondary outcomes

  1. Rate of All-Cause Hospitalization

    Time frame: up to 31 months

  2. Rate of Atrial Fibrillation(AF)-Related Hospitalization

    Time frame: up to 31 months

  3. Rate of All-Cause Any Rehospitalization

    Time frame: up to 31 months

  4. Rate of AF-Related Any Rehospitalization

    Time frame: up to 31 months

  5. Rate of All-Cause Early Hospitalization

    Time frame: up to 31 months

  6. Rate of AF-Related Early Hospitalization

    Time frame: up to 31 months

  7. All-Cause Healthcare per patient per month (PPPM) cost

    Time frame: up to 31 months

  8. AF-related Healthcare per patient per month (PPPM) cost

    Time frame: up to 31 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2016
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.