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Anticoagulant

Pharmacist-Managed Anticoagulation for Atrial Fibrillation (APOTHECARYAF Trial)

Phase 4

Recruiting

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

AF and on sub-optimal or inappropriate OAC therapy

Men (CHADS-VASc score ≥2) AND Women (CHADS-VASc score ≥3)

Must not have

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)

Inability to read or understand English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will compare the effects of having a pharmacist manage anticoagulant medication for those with atrial fibrillation and stroke risk factors to the usual care, which is receiving notification of the condition and being advised to schedule a physician visit. The goal is to see if the pharmacist-led management results in more patients being treated according to guidelines.

Who is the study for?

This trial is for people over 60 with atrial fibrillation at risk of stroke, not on optimal blood thinner therapy or not on it at all. They must be able to consent and follow the study's procedures. Excluded are those already well-managed on blood thinners, needing them for other conditions, heavy drinkers, with severe hypertension or cognitive issues, recent major surgery or bleeding history.

What is being tested?

The study tests if pharmacist-led management of oral anticoagulants (blood thinners) in community pharmacies improves treatment adherence compared to usual care where doctors are alerted about patients' needs but patients must visit the clinic themselves.

What are the potential side effects?

While specific side effects aren't listed here, common ones related to oral anticoagulants include increased risk of bleeding, potential bruising easily, digestive discomforts like nausea or diarrhea, and sometimes allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have atrial fibrillation and my current blood thinner medication isn't right for me.

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I am a man with a CHADS-VASc score of 2 or more, or a woman with a score of 3 or more.

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I am older than 60 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had serious bleeding in the last year.

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I cannot read or understand English or Spanish.

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I am currently on two medications to prevent blood clots.

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I am on the best blood thinner for my atrial fibrillation.

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I have not had major surgery in the last month.

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I have severe kidney disease or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Optimal OAC Therapy

Secondary study objectives

'Actionable' AF Prevalence

Healthcare Utilization

Medication Adherence (NOAC)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pharmacist Intervention ArmExperimental Treatment1 Intervention

Pharmacist to prescribe/monitor/manage oral anticoagulation therapy for atrial fibrillation stroke prophylaxis (under collaborative practice agreement with participants primary care provider) in accordance with ACC/AHA/HRS Guidelines.

Group II: Enhanced Usual Care Control ArmActive Control1 Intervention

Pharmacist to notify primary care provider that patient has 'actionable' atrial fibrillation and provide current medication list.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral anticoagulant

2019

N/A

~3740

0 / 9Eligibility criteria met