A Trial of Pharmacist Management of Oral Anticoagulation THerapy in the communitY for AF
Completed · Phase 4
Conditions studied: Atrial Fibrillation, Stroke
In brief
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.
Key facts
- Study ID
- NCT04907825
- Run by
- Cedars-Sinai Medical Center
- People needed
- 14
- Starts
- 2023-03-13
- Expected to finish
- 2026-01-31
- Last updated by the study team
- 2026-08-10
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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