N/A N=109

Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT04435769 ↗

Enrolled (actual)

109

Serious AEs

11.0%

Results posted

Feb 2023

Primary outcome: Primary: CHA2-DS2-VASc Score at Baseline — 4.6; 4.3 Units on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY CHA2-DS2-VASc Score at Baseline	4.6; 4.3	—
PRIMARY HAS-BLED Score at Baseline	2.7; 2.5	—
PRIMARY CHA2-DS2-VASc Score at Month 6	5.0; 4.9	—
PRIMARY HAS-BLED Score at Month 6	3.1; 2.8	—
PRIMARY Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment	55.0; 44.4; 32.5; 36.5; 12.5; 9.5	—
PRIMARY Cost of Outpatient Visits During First 6 Months of Treatment	258.8; 414.3	—
PRIMARY Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment	97.5; 0.0; 2.5; 4.8; 0.0; 46.0	—
PRIMARY Cost of INR Measurements During First 6 Months of Treatment	5.3; 4003.0	—
PRIMARY Dosage of Warfarin and Apixaban at the Initiation of the Treatment	7.5; 5.9	—
PRIMARY Dosage of Warfarin and Apixaban During First 6 Months of Treatment	7.4; 4.6	—
PRIMARY Cost of Medication During First 6 Months of Treatment	8551.0; 1263.5	—
PRIMARY Percentage of Participants Categorized According to Number of Hospital Admissions	95.0; 81.0; 2.5; 14.3; 0.0; 4.8	—
PRIMARY Cost of Hospital Admissions During First 6 Months of Treatment	2777.5; 12326.8	—
PRIMARY Percentage of Participants Categorized According to Number of Diagnostic Procedures	—	—
PRIMARY Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment	2.5; 0.0; 0.0; 9.5	—
PRIMARY Cost of Ischemic Events During First 6 Months of Treatment	684.8; 5386.6	—
PRIMARY Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment	2.5; 3.2	—
PRIMARY Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment	2.5; 0.0; 0.0; 1.6; 2.5; 0.0	—
PRIMARY Cost of Major Hemorrhagic Events During First 6 Months of Treatment	2092.7; 2657.4	—
PRIMARY Cost of Minor Hemorrhagic Events During First 6 Months of Treatment	1285.1; 1666.7	—
PRIMARY Number of Participants With Other Adverse Events During First 6 Months of Treatment	2; 1	—
PRIMARY Cost of Other Adverse Events During First 6 Months of Treatment	2063.9; 1328.7	—
PRIMARY Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment	0.0; 1.6	—

Summary

To describe the direct costs related to warfarin/apixaban treatment

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04435769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.