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

NCT ID: NCT07242326

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-06-30

Brief 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.

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.

Conditions

Medication Adherence; Atrial Fibrillation (AF); Direct Oral Anticoagulants (DOACs)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ordu University Faculty of Medicine, Department of Cardiology

UNKNOWN

Sponsor Role: collaborator

Kotyora Family Medicine Health Management and Education Association

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seçkin Dereli, MD, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Ordu University Faculty of Medicine, Department of Cardiology (Turkey)

Central Contacts

Seçkin Dereli, MD, Assoc. Prof.

Role: CONTACT

drseckindereli@gmail.com

+90 533 376 09 84

Bestegül Çoruh Akyol, MD, Asst. Prof.

Role: CONTACT

kahsedbilimseldestek@gmail.com

+90 532 584 99 38

Other Identifiers

KAHSED-002

Identifier Type: OTHER

Identifier Source: secondary_id

pending

Identifier Type: OTHER

Identifier Source: secondary_id

KAHSED-002

Identifier Type: -

Identifier Source: org_study_id