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Atrial FibrillationPhase 4APOTHECARYAFNCT04907825

A Trial of Pharmacist Management of Oral Anticoagulation THerapy in the communitY for AF

A Phase 4 study testing Oral anticoagulant in people with Atrial Fibrillation and Stroke, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, single-arm, feasibility pilot study of 20 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) recruited from a total of 4 retail and outpatient community pharmacies. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation, Stroke
What is being tested?
Oral anticoagulant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
13 Mar 2023to 31 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age > 60 years
  • Men (CHADS-VASc score ≥2) AND Women (CHADS-VASc score ≥3)
  • AF and not on OAC therapy but eligible
  • AF and on sub-optimal or inappropriate OAC therapy
  • Written informed consent

Who cannot join

  • AF on optimal OAC therapy
  • OAC required for other conditions (i.e. DVT/PE, PCI in prior year, left ventricular thrombus, etc.)
  • Currently taking two antiplatelet agents
  • Uncontrolled hypertension (defined as SBP ≥160 mmHg x 2 BP readings measured at screening)
  • End-stage renal disease (CrCl <15 ml/min or dialysis)
  • Major surgery in prior month (defined as surgery requiring general anesthesia and overnight inpatient hospital stay)
Show all 12Show fewer
  • History of "major bleeding" in prior year (defined as overt bleeding at critical site including intracranial, intraspinal, intraocular, pericardial, GI bleed, bleed requiring hospitalization, bleed resulting in ≥20 g/L drop in hemoglobin or requiring transfusion of ≥2 units packed cells)
  • Excess alcohol intake (≥8 alcoholic drinks/week)
  • Inability to read or understand English or Spanish
  • Participants considered unreliable by the Investigator or designated pharmacy team member concerning the requirements of follow-up, or those with foreshortened life expectancy precluding 3-month follow-up
  • Severe cognitive impairment (≥5 errors on the Short Portable Mental Status Questionnaire)
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF (APOTHECARY AF Study)

This is a prospective, single-arm, feasibility pilot study of 20 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) recruited from a total of 4 retail and outpatient community pharmacies. Eligible participants will be enrolled in a 3-month active intervention of pharmacist-led OAC management. Participants will be passively followed for an additional 9 months to determine safety endpoints.

Read the detailed description

Oral anticoagulation therapy for stroke prevention in AF is safe and effective but under-utilized. Optimal delivery of existing therapies would prevent AF-related stroke. Therefore alternative strategies to increase adherence to current guidelines for OAC use for AF stroke prevention should be explored.

Accumulating data indicate that pharmacist-led or pharmacist-collaborative care in cardiovascular disease monitoring, risk factor control, and medication optimization leads to greater adherence to guideline-directed targets and improved outcomes.

In this prospective, single-arm, feasiblity pilot study the investigators intend to enroll 20 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 4 retail and outpatient community pharmacies in Los Angeles. Eligible participants will be enrolled in a 3-month active intervention of pharmacist-led OAC management. Participants will be passively followed for an additional 9 months to determine safety endpoints.

The primary objective(s) will be to determine the prevalence of 'actionable' AF in the community and the proportion of patients receiving guideline concordant OAC therapy at 3 months. Secondary outcomes include: patient satisfaction with pharmacist services (at 3 months), pharmacists' perspective on study implementation (at 1 month and 3 months), OAC adherence (at 12 months), and healthcare utilization (at 12 months).

This research will generate new knowledge on an innovative, and potentially sustainable stroke prevention strategy to increase evidence-based use of OAC therapy in patients with AF.

Being tested
Oral anticoagulant
Keywords
Atrial Fibrillation, Stroke, Oral Anticoagulants, Pharmacist Case Management
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral anticoagulantDrug

    Also called warfarin, novel oral anticoagulants

    Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines

Study groups in NCT04907825
Study groupRoleWhat they receive
Pharmacist Intervention ArmExperimentalPharmacist to prescribe/monitor/manage oral anticoagulation therapy for atrial fibrillation stroke prophylaxis (under collaborative practice agreement with participants primary care provider) in accordance with ACC/AHA/HRS Guidelines.
Receives: Drug: Oral anticoagulant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optimal OAC Therapy

    To determine the proportion of patients with 'actionable AF' receiving optimal OAC therapy at 3 months.

    Measured: At 3 months and 12 months

Secondary outcomes (6)

  1. 'Actionable' AF Prevalence

    To determine the prevalence of patients with 'actionable AF'

    Measured: At 12 months

  2. Medication Adherence (NOAC)

    To assess OAC adherence (i.e. proportion of days covered (PDC) for NOACS)

    Measured: At 12 months

  3. Medication Adherence (Warfarin)

    To assess OAC adherence (i.e. time in the therapeutic range (TTR) for warfarin)

    Measured: At 12 months

  4. Patient Satisfaction with Pharmacist Services

    To assess patient satisfaction with pharmacist services using 22-item questionnaire

    Measured: At 3 months

  5. Qualitative Review of Program Implementation

    To perform a qualitative review of program implementation by surveying pharmacists about their experiences with 11-item questionnaire

    Measured: At 1 month and 3 months post-implementation

  6. Healthcare Utilization

    To assess healthcare utilization (i.e. the number of physician visits, specialist visits, ED visits, and hospitalizations)

    Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start13 Mar 2023
  3. Primary completion31 Aug 2025
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, single-arm, feasibility pilot study
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907825
Sponsor's protocol ID
00000850
Acronym
APOTHECARYAF
Status last verified
Aug 2026
First submitted
13 May 2021
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blyler CA, Jones EM, Mittman BS, Chen SW, Albert CM, Sandhu RK; APOTHECARY AF Collaborators. Pharmacist management of oral anticoagulation for atrial fibrillation in the community: The APOTHECARY AF study. Heart Rhythm O2. 2026 Aug 7;7(10):1923-1932. doi: 10.1016/j.hroo.2026.07.012. eCollection 2026 Oct.

    PubMed 42936080

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral anticoagulant in people with Atrial Fibrillation and Stroke, run by Cedars-Sinai Medical Center at 1 site in United States.

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 5 inclusion and 12 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: finished, as of the sponsor's last update on 10 Aug 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Optimal OAC Therapy (time frame: At 3 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04907825, which also lists 1 linked publication.

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 10 Aug 2026.

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