CompletedPhase 4

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

United States14 participantsStarted 2023-03-13

Plain-language 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.

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Optimal OAC Therapy

Timeframe: At 3 months and 12 months

Trial details

NCT IDNCT04907825

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Atrial Fibrillation trials