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Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

Last updated on April 10, 2018

FOR MORE INFORMATION
Study Location
IDIAP Jordi Gol
Barcelona, Cataluña, 8007 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients more than 18 years-old.

2. Patients diagnosed with NVAF registered in primary care according to ICD-10.

3. Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA
experienced), dabigatran or rivaroxaban for the SPAF indication.

4. Continuous enrolment in the 12 months pre-index.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including
patients with mitral prosthetic valves.

2. Lost to follow-up (e.g. transfer to primary care center non-ICS).

NCT03441633
Pfizer
Completed
Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

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Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)
Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)
Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.

The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.

In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.

Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.

Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.

Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.

Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort.

Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

SIDIAP currently collects information from 274 primary health care centers, including more than 5.8 million patients, about 80 % of the Catalonia population, or more than 10 % of the Spanish population covered by the Catalan Institute of Health.

The study population for these cohorts includes all eligible subjects from the source population with a first -recorded prescription of apixaban VKA, dabigatran or rivaroxaban for the SPAF indication, registered in SIDIAP database and diagnosis of NVAF for study period.

Atrial Fibrillation
  • Drug: apixaban
    current or new medication
  • Drug: dabigatran
    current or new medication
  • Drug: VKA
    current or new medication
  • Drug: rivaroxaban
    current or new medication
  • Group 1. Apixaban

    Patients who are on treatment with apixaban.

    1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

    1b. patients who previously have been treated with VKA in the 12 months before index date.

    Intervention: Drug: apixaban
  • Group 2. VKA

    Patients who are on treatment with VKA.

    2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

    2b. patients who previously have been treated with VKA in the 12 months before index date.

    Intervention: Drug: VKA
  • Group 3. Dabigatran

    Patients who are on treatment with dabigatran.

    3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

    3b. patients who previously have been treated with VKA in the 12 months before index date.

    Intervention: Drug: dabigatran
  • Group 4. Rivaroxaban

    Patients who are on treatment with rivaroxaban.

    4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

    4b. patients who previously have been treated with VKA in the 12 months before index date.

    Intervention: Drug: rivaroxaban
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
March 8, 2017
March 8, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients more than 18 years-old.
  2. Patients diagnosed with NVAF registered in primary care according to ICD-10.
  3. Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
  4. Continuous enrolment in the 12 months pre-index.

Exclusion Criteria:

  1. Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
  2. Lost to follow-up (e.g. transfer to primary care center non-ICS).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT03441633
B0661076
SPAF ( Other Identifier: Alias Study Number )
Yes
Not Provided
Plan to Share IPD: No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2018

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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