Medication AdherenceSNAP AF-52NCT07242326
SNAP AF-52: Dose Appropriateness and Adherence to Oral Anticoagulation in Adults ≥65 With Atrial Fibrillation in Primary Care (Ordu, Türkiye)
An observational study of Medication Adherence and Atrial Fibrillation (AF), run by Kotyora Family Medicine Health Management and Education Association at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Adherence, Atrial Fibrillation (AF), Direct Oral Anticoagulants (DOACs)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ordu University Faculty of Medicine, Department of Cardiology
Ordu, Ordu, 52200
About this study
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
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.
Read the 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.
- Keywords
- DOAC;, apixaban, rivaroxaban, dabigatran, edoxaban, dose appropriateness, label-concordant dosing, Proportion of Days Covered (PDC), primary nonadherence, ISTH major bleeding, primary care
- Medical subject headings
- Medication Adherence, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Prior 12 months relative to index date
Secondary outcomes (4)
Secondary Outcome 1: Primary Nonadherence
Yes if no pharmacy dispensing within 30 days of the first OAC prescription.
Measured: From first prescription within the 12-month
Secondary Outcome 2: Ischemic Events
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.
Measured: 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).
Measured: 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.
Measured: At index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kotyora Family Medicine Health Management and Education Association
- Sponsor type
- Research network
- Collaborators
- Ordu University Faculty of Medicine, Department of Cardiology
- Responsible party
- Sponsor
- Investigators
- Seçkin Dereli, MD, Assoc. Prof., Principal investigator, Ordu University Faculty of Medicine, Department of Cardiology (Turkey)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242326
- Sponsor's protocol ID
- KAHSED-002
- Other IDs
- KAHSED-002, pending
- Acronym
- SNAP AF-52
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07242326
- Acronym / sponsor ID
- SNAP AF-52 / KAHSED-002
- Keywords
- DOAC;, apixaban, rivaroxaban, dabigatran, edoxaban, dose appropriateness, label-concordant dosing, Proportion of Days Covered (PDC)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kotyora Family Medicine Health Management and Education AssociationResearch network
- Collaborators
- Ordu University Faculty of Medicine, Department of Cardiology
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome 1: Label-Concordant Dose Proportion
Time frame: 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%)
Time frame: 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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seçkin Dereli, MD, Assoc. Prof. principal investigator
Ordu University Faculty of Medicine, Department of Cardiology (Turkey)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence and Atrial Fibrillation (AF), run by Kotyora Family Medicine Health Management and Education Association at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1: Label-Concordant Dose Proportion (time frame: At index visit (assessed using baseline variables and the most recent renal function).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.