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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Drug: Oral anticoagulant

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. AF on optimal OAC therapy
2. OAC required for other conditions (i.e. DVT/PE, PCI in prior year, left ventricular thrombus, etc.)
3. Currently taking two antiplatelet agents
4. Uncontrolled hypertension (defined as SBP ≥160 mmHg x 2 BP readings measured at screening)
5. End-stage renal disease (CrCl <15 ml/min or dialysis)
6. Major surgery in prior month (defined as surgery requiring general anesthesia and overnight inpatient hospital stay)
7. 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)
8. Excess alcohol intake (≥8 alcoholic drinks/week)
9. Inability to read or understand English or Spanish
10. 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
11. Severe cognitive impairment (≥5 errors on the Short Portable Mental Status Questionnaire)
12. Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist Intervention Arm; Pharmacist 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.	Drug: Oral anticoagulant; Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines; Other Names: warfarin; novel oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal OAC Therapy	To determine the proportion of patients with 'actionable AF' receiving optimal OAC therapy at 3 months.	At 3 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence (NOAC)	To assess OAC adherence (i.e. proportion of days covered (PDC) for NOACS)	At 12 months
Medication Adherence (Warfarin)	To assess OAC adherence (i.e. time in the therapeutic range (TTR) for warfarin)	At 12 months
Patient Satisfaction with Pharmacist Services	To assess patient satisfaction with pharmacist services using 22-item questionnaire	At 3 months
Healthcare Utilization	To assess healthcare utilization (i.e. the number of physician visits, specialist visits, ED visits, and hospitalizations)	At 12 months
'Actionable' AF Prevalence	To determine the prevalence of patients with 'actionable AF'	At 12 months
Qualitative Review of Program Implementation	To perform a qualitative review of program implementation by surveying pharmacists about their experiences with 11-item questionnaire	At 1 month and 3 months post-implementation

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Oral Anticoagulants; Pharmacist Case Management
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Coumarins; Benzopyrans; 4-Hydroxycoumarins; Hematologic Agents; Warfarin; Anticoagulants
• Other Study ID Numbers: 00000850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes