Status:
ACTIVE_NOT_RECRUITING
A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
This is a prospective, open-label, cluster-randomized controlled trial of 400 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total o...
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 strateg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04907825
Start Date
March 13 2023
End Date
January 31 2026
Last Update
December 24 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048