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

NCT04907825 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 00000850
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Stroke

Keywords

Atrial Fibrillation; Stroke; Oral Anticoagulants; Pharmacist Case Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 'Actionable' AF Prevalence

  At 12 months

• Medication Adherence (NOAC)

  At 12 months

• Medication Adherence (Warfarin)

  At 12 months

• Patient Satisfaction with Pharmacist Services

  At 3 months

• Qualitative Review of Program Implementation

  At 1 month and 3 months post-implementation

Study Arms (1)

Pharmacist Intervention Arm

EXPERIMENTAL

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

Interventions

Oral anticoagulant DRUG

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

Also known as: warfarin, novel oral anticoagulants

Pharmacist Intervention Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Anticoagulants; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, single-arm, feasibility pilot study

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 1, 2021
• Study Start: March 13, 2023
• Primary Completion: August 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)