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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

APOTHECARYAF Trial 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.Check my eligibility

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.See study design

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.

APOTHECARYAF Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

I am older than 60 years.

APOTHECARYAF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Optimal OAC Therapy

Secondary outcome measures

'Actionable' AF Prevalence

Healthcare Utilization

Medication Adherence (NOAC)

+3 more

APOTHECARYAF 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,525 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,463 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

30 Patients Enrolled for Atrial Fibrillation

Media Library

Oral anticoagulant (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04907825 — Phase 4

Atrial Fibrillation Research Study Groups: Pharmacist Intervention Arm, Enhanced Usual Care Control Arm

Atrial Fibrillation Clinical Trial 2023: Oral anticoagulant Highlights & Side Effects. Trial Name: NCT04907825 — Phase 4

Oral anticoagulant (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907825 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic conditions typically call for the prescription of oral anticoagulant?

"Thromboembolism is commonly treated with anticoagulants that are administered orally. These medications may also be employed to prevent venous thrombosis, stroke, and mechanical heart valve issues."

Answered by AI

What other explorations have been conducted with Oral anticoagulant?

"Presently, there are 26 clinical trials for Oral anticoagulant with 9 in their final stage. These studies are primarily conducted throughout Montreal and its surrounding area, though 379 centres across the globe have research underway related to this medication."

Answered by AI

Does this research offer any more opportunities for participants?

"Affirmative. According to the clinicaltrials.gov website, this medical trial is currently recruiting and was first posted on January 1st of 2022 with a recent update made on March 7th of 2022. A total of 380 individuals are expected to be accepted at one research site."

Answered by AI

Has the Oral anticoagulant been officially sanctioned by the Federal Drug Administration?

"There is ample evidence that Oral anticoagulant has been approved for market use; thus, the safety score assigned was a 3."

Answered by AI

How many participants can be recruited for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research is openly recruiting participants since its initial posting on January 1st 2022 and last update of March 7th 2022. For the trial to be successful, 380 individuals need to enroll at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Roopinder Sandhu 2023. "A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04907825.

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