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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714855
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date March 16, 2016
First Posted Date March 22, 2016
Last Update Posted Date April 19, 2017
Study Start Date October 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2016)
  • Patient characteristics in NVAF patients initiating a new AC-treatment [ Time Frame: Approximately 12 months ]
    Patient's characteristics: age, gender, weight and height, BMI, dependence status
  • Comparing patient characteristics between apixaban and other Novel anticoagulants (NOACs) in AC-naive patients [ Time Frame: Approximately 12 months ]
  • Comparing patient characteristics between apixaban and Vitamin K antagonists (VKAs) in AC-naive patients [ Time Frame: Approximately 12 months ]
  • Disease characteristics in NVAF patients initiating a new AC-treatment [ Time Frame: Approximately 12 months ]
    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
  • Comparing disease characteristics between apixaban and other NOACs in AC-naive patients [ Time Frame: Approximately 12 months ]
  • Comparing disease characteristics between apixaban and VKAs in AC-naive patients [ Time Frame: Approximately 12 months ]
  • Comorbidities in NVAF patients initiating a new AC-treatment [ Time Frame: Approximately 12 months ]
    Comorbidities: congestive heart failure history, hypertension, diabetes mellitus, stroke/transient ischemic attack)/thromboembolism history, vascular disease history, renal impairment, liver impairment, prior major bleeding
  • Comparing comorbidities characteristics between apixaban and other NOACs in AC-naive patients [ Time Frame: Approximately 12 months ]
  • Comparing comorbidities characteristics between apixaban and VKAs in AC-naive patients [ Time Frame: Approximately 12 months ]
  • Treatment history in NVAF patients initiating a new AC-treatment [ Time Frame: Approximately 12 months ]
    Treatment history: Previous AC strategy (no treatment, apixaban, other NOAC, VKAs) , Duration with previous AC strategy and indication of previous AC treatment
  • Comparing treatment history characteristics between apixaban and other NOACs in AC-naive patients [ Time Frame: Approximately 12 months ]
  • Comparing treatment history characteristics between apixaban and VKAs in AC-naive patients [ Time Frame: Approximately 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2016)
  • Distribution of previous AC strategy (no treatment, apixaban, other NOAC, VKAs) [ Time Frame: Approximately 12 months ]
  • Distribution of reasons for discontinuing previous AC treatment among patients who had previous AC treatment [ Time Frame: Approximately 12 months ]
    Reason(s) for discontinuing previous AC strategy (multiple choices accepted): Minor Bleeding event, major bleeding event, gastro-intestinal bleeding, dosing frequency, high bleeding risk, fear of side effect, cost and concern with renal function, dyspepsia, frequent falls or frailty, patient decision, concomitant treatment, concomitant chronic disease
  • Distribution of prescriber (Cardiologist him/herself, General Practitioner (GP), other) [ Time Frame: Approximately 12 months ]
  • Distribution of reasons for initiating a new AC treatment [ Time Frame: Approximately 12 months ]
  • Distribution of reasons for choosing the newly initiated AC treatment [ Time Frame: Approximately 12 months ]
    Reason(s) for choosing the newly initiated AC treatment (multiple choices accepted): Physician preference, patient preference, results of a specific trial in relation to the clinical setting, cost and dosing frequency
  • Conditions of prescription of apixaban in NVAF patients [ Time Frame: Approximately 12 months ]
    Condition of prescription of apixaban: Daily dosage (mg) at apixaban initiation, number of doses per day at apixaban initiation
  • Proportion of AC-naive patients [ Time Frame: Approximately 12 months ]
  • Proportion of AC-experienced patients [ Time Frame: Approximately 12 months ]
  • Mean daily dosage of daily doses for prescribed apixaban treatment according to patient characteristics [ Time Frame: Approximately 12 months ]
  • Mean number of daily doses for prescribed apixaban treatment according to patient characteristics [ Time Frame: Approximately 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France
Official Title Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study
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?

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cardiologists in france caring AF patients
Condition Anticoagulation
Intervention Drug: Apixaban
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 28, 2017)
2081
Original Estimated Enrollment
 (submitted: March 16, 2016)
1000
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02714855
Other Study ID Numbers CV185-345
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2017