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

Launched by CEDARS-SINAI MEDICAL CENTER · May 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how effective pharmacist management of blood-thinning medications is for older adults with a heart condition called atrial fibrillation (AF), which can increase the risk of stroke. The trial involves 400 participants aged 60 and older who either haven’t been treated with blood thinners (oral anticoagulants) or are on the wrong dose. Participants will be divided into two groups: one where pharmacists will help manage their medication, and another where doctors will be notified about their AF, but patients will need to schedule a visit with their doctor for further care. The main goal is to see how many patients in each group are receiving the right treatment after three months.

To join the trial, potential participants must be over 60, have specific risk factors for stroke, and either not be on blood thinners or be on the wrong kind. Participants can expect to work closely with pharmacists who will guide them on their medication and monitor their health. It’s also important to note that individuals with certain health conditions or those who are currently receiving optimal blood thinner therapy are not eligible for this trial.

Gender

ALL

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