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

Last updated on December 12, 2019

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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Descriptive Information
Brief Title Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)
Official Title APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF)
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

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.

Condition Atrial Fibrillation
Intervention
  • Drug: apixaban
    current or new medication
  • Drug: dabigatran
    current or new medication
  • Drug: VKA
    current or new medication
  • Drug: rivaroxaban
    current or new medication
Study Groups/Cohorts
  • 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
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: January 15, 2019)
51690
Original Actual Enrollment
 (submitted: February 15, 2018)
1
Actual Study Completion Date March 8, 2017
Actual Primary Completion Date March 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03441633
Other Study ID Numbers B0661076
SPAF ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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