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Enrolling by invitation Observational

SNAP AF-52: Dose Appropriateness and Adherence to Oral Anticoagulation in Adults ≥65 With Atrial Fibrillation in Primary Care (Ordu, Türkiye)

NCT07242326 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-12-15
Last updated
2026-02-25

Condition(s) studied

Medication AdherenceAtrial Fibrillation (AF)Direct Oral Anticoagulants (DOACs)

Study summary

SNAP AF-52 is an ambidirectional observational registry conducted in family health centers (primary care) across Ordu, Türkiye, enrolling adults ≥65 years with a pre-existing diagnosis of atrial fibrillation. The study assesses (a) label-concordant dosing of oral anticoagulants (DOACs/warfarin) using drug-specific criteria, and (b) medication adherence via Proportion of Days Covered (PDC) over the prior 12 months (good adherence defined as PDC ≥80%). Unsafe findings (e.g., suspected under-/overdosing, critical drug-drug interactions, very low renal function) trigger same-day referral to tertiary cardiology for evaluation and management. The retrospective window is Dec 1, 2024-Nov 30, 2025; the prospective single-visit inclusion window is Dec 1, 2025-May 31, 2026. No experimental treatment is administered; all care is routine.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥65 years. * Established atrial fibrillation (any type) documented in the medical record. * Presenting to a family health center (primary care) in Ordu province during the prospective window or having records within the retrospective window. * On an oral anticoagulant (DOAC) at any time in the 12-month window. Exclusion Criteria: * Mechanical prosthetic heart valve or moderate-to-severe rheumatic mitral stenosis * Participation in an interventional drug study affecting anticoagulation * Lack of minimal data elements required for dose classification (age, sex, body weight, serum creatinine with date, current OAC and regimen) * Investigator judgment that reliable data cannot be obtained from records

Primary outcome measure(s)

  • Primary Outcome 1: Label-Concordant Dose Proportion — At index visit (assessed using baseline variables and the most recent renal function).
    Proportion of patients on label-concordant dose vs underdose vs overdose, by anticoagulant. Criteria include: Apixaban: 5 mg BID (standard) or 2.5 mg BID if ≥2 of: age ≥80 years, weight ≤60 kg, serum creatinine ≥1.5 mg/dL. Rivaroxaban: 20 mg QD if CrCl ≥50 mL/min; 15 mg QD if CrCl 15-49; avoid/evaluate if CrCl \<15. Dabigatran: 150 mg BID (standard); 110 mg BID considered if age ≥80 or if CrCl 30-50 and P-gp inhibitor; avoid/evaluate if CrCl \<30. Edoxaban: 60 mg QD (standard); 30 mg QD if CrCl 15-50, weight ≤60 kg, or specific P-gp inhibitors (e.g., dronedarone, verapamil, erythromycin, ketoconazole, cyclosporine); consider reduced efficacy if CrCl \>95.
  • Primary Outcome 2: Good Adherence (PDC ≥80%) — Prior 12 months relative to index date
    Proportion of Days Covered (PDC) = (covered days / 365), with early refill carry-over and single-day duplicate fills not double-counted. Good adherence: PDC ≥80% (class-level and drug-specific PDC reported).

Trial sites (1)

FacilityCityRegionStatus
Ordu University Faculty of Medicine, Department of Cardiology Ordu Ordu

More Kotyora Family Medicine Health Management and Education Association trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07242326 on ClinicalTrials.gov ↗ ← All trials in Turkey