NCT04907825

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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. 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.

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.

Conditions

• Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DRUG	Oral anticoagulant	Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines

Timeline

• Start date: 2023-03-13
• Primary completion: 2025-08-31
• Completion: 2026-01-31
• First posted: 2021-06-01
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study