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| ID | Type | Description | Link |
|---|---|---|---|
| KAHSED-002 | Other Identifier | Kotyora Family Medicine Health Management and Education Association (KAHSED) | |
| pending | Other Identifier | Ordu University Non-Interventional Clinical Research Ethics Committee |
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| Name | Class |
|---|---|
| Ordu University Faculty of Medicine, Department of Cardiology | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Records Cohort | Adults aged ≥65 years with atrial fibrillation and any oral anticoagulant use documented within Dec 1, 2024-Nov 30, 2025. Data are abstracted from existing records to determine dose appropriateness at the index regimen and 12-month PDC, and to capture ischemic (I63/G45/I74) and hemorrhagic (I60-I62; ISTH major) events. No patient contact and no protocol-assigned treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome 1: Label-Concordant Dose Proportion | 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. | At index visit (assessed using baseline variables and the most recent renal function). |
| Primary Outcome 2: Good Adherence (PDC ≥80%) | 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). | Prior 12 months relative to index date |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome 1: Primary Nonadherence | Yes if no pharmacy dispensing within 30 days of the first OAC prescription. | From first prescription within the 12-month |
| Secondary Outcome 2: Ischemic Events |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged ≥65 years with established atrial fibrillation (any type) receiving care in family health centers across Ordu, Türkiye. The prospective cohort enrolls consecutive eligible attendees during Dec 1, 2025-May 31, 2026 at a single routine visit; the retrospective cohort includes patients with AF who received an oral anticoagulant during Dec 15, 2025-May 31, 2026 identified from primary care records. Exclusions: mechanical prosthetic heart valve or moderate-severe rheumatic mitral stenosis, and cases lacking the minimal data needed for dose/adherence classification. No investigational treatment is delivered; care is routine with same-day tertiary referral when unsafe dosing, high-risk drug interactions, or very low renal function are detected.
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| Name | Affiliation | Role |
|---|---|---|
| Seçkin Dereli, MD, Assoc. Prof. | Ordu University Faculty of Medicine, Department of Cardiology (Turkey) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordu University Faculty of Medicine, Department of Cardiology | Ordu | Ordu | 52200 | Turkey (Türkiye) |
Individual participant data will not be shared because identifiers are retained in the working dataset to enable same-day clinical referral and safety follow-up, and the ethics approval (and patient permissions) limit use to quality-of-care evaluation within participating centers. De-identification sufficient for public sharing would require extensive linkage files and could still pose re-identification risk in a single-province cohort under local data-protection law (KVKK). We will share only aggregated, de-identified results (tables/figures) upon reasonable request and after ethics approval; the study protocol, CRF, and PDC calculation SOP can be provided as supporting documents.
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Proportion with ischemic stroke (ICD-10 I63.x), TIA (G45.x), or systemic arterial embolic event (I74.x); event-date on-treatment status derived from dispensing coverage.
| Prior 12 months. |
| Secondary Outcome 3: Hemorrhagic Events | Hemorrhagic stroke (I60-I62) and ISTH major bleeding (any of: fatal; critical site-including intracranial/intraspinal/intraocular/pericardial/intra-articular/intramuscular with compartment syndrome; Hb drop ≥2 g/dL; or ≥2 RBC units transfused). Location examples: GI (K92.2; K25-K28 with hemorrhage), GU (R31/N02), pulmonary (R04.2), intra-ocular (H43.1/H35.6). | Prior 12 months |
| Secondary Outcome 4: Same-Day Tertiary Referral Rate | Proportion referred same-day to tertiary cardiology due to unsafe dose, high-risk interaction (e.g., strong inducer/strong dual inhibitor), or CrCl <15 mL/min. | At index visit |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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