Pharmacist management of anticoagulation therapy for atrial fibrillation

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

This study is testing if having pharmacists manage blood-thinning medication for older adults with atrial fibrillation helps them get better treatment than standard care from their doctors.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT04907825 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of pharmacist-led management of oral anticoagulation (OAC) therapy compared to enhanced usual care for patients with atrial fibrillation (AF) who are not receiving optimal treatment. It involves 400 participants aged 60 and older, recruited from 40 community pharmacies in Los Angeles. Participants will be randomized to receive either pharmacist-led OAC management or standard care, where physicians are notified of patients' AF status. The primary goal is to assess the proportion of patients receiving guideline-concordant OAC therapy after three months.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older with atrial fibrillation who are either not on oral anticoagulation therapy or are on sub-optimal therapy.

Not a fit: Patients currently receiving optimal oral anticoagulation therapy or those with contraindications to anticoagulation will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of atrial fibrillation and reduce the risk of stroke in patients.

How similar studies have performed: Previous studies have shown that pharmacist-led care can improve adherence to treatment guidelines and patient outcomes, suggesting a promising approach.

Eligibility criteria

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

Where this trial is running

Los Angeles, California

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Roopinder K Sandhu, MD

Conditions Atrial Fibrillation; Stroke; Oral Anticoagulants; Pharmacist Case Management