Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France

NCT02714855 | Completed

• 1 other identifier: CV185-345
• Study Type: observational
• Target: 2,081
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will be conducted to assess the following research questions in real-life conditions in France: What are the patient and disease characteristics, comorbidities and treatment history in NVAF patients initiating a new Anticoagulant (AC) treatment, according to treatment currently available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles different from one treatment pattern to another when initiating a new AC treatment? What are the HCP's reasons for discontinuing the previous AC strategy for initiating and choosing the newly initiated AC treatment in NVAF patients? What are the conditions of newly-initiated apixaban prescriptions in NVAF patients: prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (12)

• Patient characteristics in NVAF patients initiating a new AC-treatment

  Patient's characteristics: age, gender, weight and height, BMI, dependence status

  Approximately 12 months

• Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients

  Approximately 12 months

• Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients

  Approximately 12 months

• Disease characteristics in NVAF patients initiating a new AC-treatment

  Disease characteristics: type of NVAF (permanent, paroxystic, persistent) ALD status (ALD: Affections de Longue Duree) for long term disease status (ALD 5, other ALDs specified, any ALD), disease duration

  Approximately 12 months

• Comparing disease characteristics between apixaban and other NOACs in AC-naive patients

  Approximately 12 months

• Comparing disease characteristics between apixaban and VKAs in AC-naive patients

  Approximately 12 months

• Comorbidities in NVAF patients initiating a new AC-treatment

  Comorbidities: congestive heart failure history, hypertension, diabetes mellitus, stroke/transient ischemic attack)/thromboembolism history, vascular disease history, renal impairment, liver impairment, prior major bleeding

  Approximately 12 months

• Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients

  Approximately 12 months

• Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients

  Approximately 12 months

• Treatment history in NVAF patients initiating a new AC-treatment

  Treatment history: Previous AC strategy (no treatment, apixaban, other NOAC, VKAs) , Duration with previous AC strategy and indication of previous AC treatment

  Approximately 12 months

• Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients

  Approximately 12 months

• Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients

  Approximately 12 months

Secondary Outcomes (10)

• Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs)

  Approximately 12 months

• Distribution of reasons for discontinuing previous AC treatment among patients who had previous AC treatment

  Approximately 12 months

• Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other)

  Approximately 12 months

• Distribution of reasons for initiating a new AC treatment

  Approximately 12 months

• Distribution of reasons for choosing the newly initiated AC treatment

  Approximately 12 months

Interventions

Apixaban DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cardiologists in france caring AF patients

You may qualify if:

• Patients aged ≥ 18 years
• Diagnosed with non valvular atrial fibrillation (NVAF)
• Prescribed with a newly initiated AC treatment (apixaban, other NOACs or VKAs). Newly initiated AC treatment is defined as any AC treatment initiated within the past 3 months, including day of enrolment

You may not qualify if:

• Patients with atrial fibrillation (AF) due to reversible causes
• Patients with a diagnosis of VAF. The term VAF is used to imply that AF is related to rheumatic valvular disease (predominantly mitral stenosis) or prosthetic heart valves
• Patients participating in an ongoing clinical trial in AF

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Fontaine-lès-Dijon, 21121, France

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

apixaban

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 22, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 19, 2017

Record last verified: 2017-03

Locations

FR (1)