Clinical trial NCT04435769: Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment
Official title: Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.

Brief summary: To describe the direct costs related to warfarin/apixaban treatment

Detailed description: To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-valvular atrial fibrillation (NVAF);
* New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
* Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
* Apixaban arm: genetically determined higher sensitivity to warfarin;
* Patients whose status allowed oral treatment with apixaban/warfarin;
* Age ≥ 18;
* Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.

Exclusion Criteria:

* Diagnosis of valvular disease;
* Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
* Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
* Contraindications according SmPC of Eliquis

Primary outcomes:
measure: CHA2-DS2-VASc Score at Baseline
timeFrame: Baseline (from retrospective data retrieved in the study)
measure: HAS-BLED Score at Baseline
timeFrame: Baseline (from retrospective data retrieved in the study)
measure: CHA2-DS2-VASc Score at Month 6
timeFrame: Month 6 (from retrospective data retrieved in the study)
measure: HAS-BLED Score at Month 6
timeFrame: Month 6 (from retrospective data retrieved in the study)
measure: Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of Outpatient Visits During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of INR Measurements During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Dosage of Warfarin and Apixaban at the Initiation of the Treatment
timeFrame: Baseline (from retrospective data retrieved in the study)
measure: Dosage of Warfarin and Apixaban During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of Medication During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Percentage of Participants Categorized According to Number of Hospital Admissions
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of Hospital Admissions During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Percentage of Participants Categorized According to Number of Diagnostic Procedures
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of Ischemic Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of Major Hemorrhagic Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Number of Participants With Other Adverse Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Cost of Other Adverse Events During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
measure: Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
timeFrame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Praha 5
country: Czechia
facility: Fakultní nemocnice Motol
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: