SNAP AF-52: Dose Appropriateness and Adherence to Oral Anticoagulation in Adults ≥65 With Atrial Fibrillation in Primary Care (Ordu, Türkiye)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Medication Adherence, Atrial Fibrillation (AF), Direct Oral Anticoagulants (DOACs). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SNAP AF-52 - An Ambidirectional Observational Study to Assess Label-Concordant Dosing and Medication Adherence (Proportion of Days Covered) for Oral Anticoagulants in Adults Aged ≥65 Years With Atrial Fibrillation Managed in Family Health Centers in Ordu, Türkiye, With Same-Day Tertiary Cardiology Referral for Unsafe Findings
Overview
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.
Detailed description
Family physicians will screen their ≥65-year attendees with documented AF and record a minimum dataset during a single routine visit: demographics, body weight, most recent serum creatinine (date/value) to compute Cockcroft-Gault creatinine clearance (CrCl), current oral anticoagulant and regimen, common interacting drugs, and pharmacy dispensing dates with days' supply for the last 12 months. The system auto-classifies dose appropriateness per drug label criteria (including apixaban reduction rules; rivaroxaban/dabigatran/edoxaban CrCl thresholds and P-gp/CYP3A4 interactions) and computes PDC with carry-over of early refills; primary nonadherence is defined as no fill within 30 days of the first prescription. Retrospective capture of events includes ischemic stroke/TIA/systemic embolic event (SEE) and hemorrhagic stroke/ISTH major bleeding, plus on-treatment status at the event date.
Participants with potentially unsafe dosing or clinically high-risk interaction (e.g., strong inducers; strong dual inhibitors) or CrCl \<15 mL/min are same-day referred to tertiary cardiology. Identifiable data will be stored securely per ethics approval and Turkish data protection (KVKK); only aggregated results will be reported.
Primary outcome measures
- Primary Outcome 1: Label-Concordant Dose Proportion [Time frame: At index visit (assessed using baseline variables and the most recent renal function).]
- Primary Outcome 2: Good Adherence (PDC ≥80%) [Time frame: Prior 12 months relative to index date]
Secondary outcome measures (4)
- Secondary Outcome 1: Primary Nonadherence [Time frame: From first prescription within the 12-month]
- Secondary Outcome 2: Ischemic Events [Time frame: Prior 12 months.]
- Secondary Outcome 3: Hemorrhagic Events [Time frame: Prior 12 months]
- Secondary Outcome 4: Same-Day Tertiary Referral Rate [Time frame: At index visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Ordu University Faculty of Medicine, Department of Cardiology — Ordu
Identifiers
NCT: NCT07242326 · KAHSED-002 · KAHSED-002 · pending