Clinical trial NCT03441633: Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)
Official title: APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
apixaban
stroke
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 51690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Number of Participants by Their Sociodemographic Characteristics: Smoking Habit
timeFrame: Day 1
measure: Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit
timeFrame: Day 1
measure: Number of Participants by Their Sociodemographic Characteristics: MEDEA
timeFrame: Day 1
measure: Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
timeFrame: Day 1
measure: Number of Participants by Comorbidity
timeFrame: Up to 12 months after date of first prescription
measure: Risk of Bleeding Events: HAS-BLED Score
timeFrame: Up to 12 months prior to enrollment
measure: Risk of Thromboembolic Events: CHADS2 Score
timeFrame: Up to 12 months prior to enrollment
measure: Risk of Thromboembolic Events: CHA2DS2Vasc Score
timeFrame: Up to 12 months prior to enrollment
measure: Number of Participants by Comedications
timeFrame: Up to 30 days after date of first prescription
measure: Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)
timeFrame: Up to 12 months after date of first prescription
measure: Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
timeFrame: Up to 12 months after date of first prescription
measure: Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
timeFrame: Up to 12 months after date of first prescription
measure: International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
timeFrame: Up to 12 months after date of first prescription
measure: Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
timeFrame: Up to 12 months after date of first prescription
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
state: Cataluña
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: