N/A
Completed N=51,690
Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)
Source: ClinicalTrials.gov NCT03441633 ↗Enrolled (actual)
51,690
Serious AEs
—
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants by Their Sociodemographic Characteristics: Smoking Habit — 207; 23; 1844; 7 Participants — p=0.000
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants by Their Sociodemographic Characteristics: Smoking Habit |
207; 23; 1844; 7; 112; 14 | 0.000 sig |
| PRIMARY Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit |
2162; 353; 11299; 40; 839; 91 | 0.000 sig |
| PRIMARY Number of Participants by Their Sociodemographic Characteristics: MEDEA |
190; 90; 1754; 16; 120; 28 | 0.000 sig |
| PRIMARY Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI) |
1424; 261; 6898; 34; 509; 87 | 0.000 sig |
| PRIMARY Number of Participants by Comorbidity |
3695; 1316; 26450; 173; 1819; 318 | 0.000 sig |
| PRIMARY Risk of Bleeding Events: HAS-BLED Score |
1.7; 2.7; 2.2; 2.5; 1.9; 2.4 | 0.000 sig |
| PRIMARY Risk of Thromboembolic Events: CHADS2 Score |
1.7; 2.8; 1.9; 2.3; 1.8; 2.5 | 0.000 sig |
| PRIMARY Risk of Thromboembolic Events: CHA2DS2Vasc Score |
3.0; 4.4; 3.2; 3.7; 2.9; 3.9 | 0.000 sig |
| PRIMARY Number of Participants by Comedications |
4712; 1406; 32212; 188; 2286; 352 | 0.008 sig |
| PRIMARY Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR) |
162; 151; 5634; 31; 103; 57 | 0.000 sig |
| PRIMARY Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year |
881; 236; 11326; 85; 1009; 127 | 0.000 sig |
| PRIMARY Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD) |
15.0; 30.0; 16.0; 16.0; 53.0; 16.0 | 0.000 sig |
| PRIMARY International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA |
2.5; 2.5; 2.5; 2.6 | — |
| PRIMARY Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA |
60.2; 59.6; 66.2; 58.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients more than 18 years-old.
- Patients diagnosed with NVAF registered in primary care according to ICD-10.
- Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
- Continuous enrolment in the 12 months pre-index.
Exclusion Criteria
- Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
- Lost to follow-up (e.g. transfer to primary care center non-ICS).
Data sourced from ClinicalTrials.gov (NCT03441633). 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. Informational only — not medical advice.