Pharmacist-Managed Anticoagulation for Atrial Fibrillation

(APOTHECARYAF Trial)

Overseen By Roopinder K Sandhu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Cedars-Sinai Medical Center

Must be taking: OAC therapy

Must not be taking: Two antiplatelet agents

Disqualifiers: Uncontrolled hypertension, End-stage renal disease, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pharmacists might manage blood thinners for individuals with atrial fibrillation (AF), a heart condition that can lead to stroke. Researchers aim to determine if direct management by pharmacists improves treatment compared to usual care from doctors. The trial targets individuals over 60 with AF who are not currently on optimal blood-thinner treatment and have an increased stroke risk. Participants will either have their medication managed by a pharmacist or receive advice to visit their doctor for care. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on optimal anticoagulation therapy or require anticoagulation for other conditions, you may not be eligible to participate.

What is the safety track record for the oral anticoagulant treatment?

Research has shown that pharmacist-managed oral anticoagulant (OAC) therapy is generally safe and well-tolerated. Studies have found that this approach can improve patient outcomes. Specifically, pharmacist-led care reduces major bleeding events and strokes in patients. This method also ensures patients receive the correct medication dosage, preventing side effects.

Further research confirms that pharmacists play a crucial role in managing bleeding risks associated with these treatments. They enhance the safety of OAC therapies for individuals with atrial fibrillation, a condition characterized by an irregular heartbeat that can lead to strokes.

In summary, pharmacist-managed OAC therapy is safe and effective, offering clear benefits in reducing bleeding risks and preventing strokes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about pharmacist-managed anticoagulation for atrial fibrillation because it offers a personalized approach to managing stroke risk. Unlike the standard care, where treatment is often primarily managed by physicians, this method involves pharmacists directly prescribing and monitoring oral anticoagulant therapy. This can lead to more precise management of medication and improved adherence to guidelines, potentially reducing the risk of strokes more effectively. Additionally, by integrating pharmacists into the care team, patients may benefit from more frequent follow-ups and adjustments, ensuring optimal treatment outcomes.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation?

Research shows that pharmacists effectively manage oral blood-thinning medication for patients with atrial fibrillation (AF). In this trial, participants in the Pharmacist Intervention Arm will have their oral anticoagulation therapy prescribed, monitored, and managed by a pharmacist under a collaborative practice agreement. Studies have found that pharmacist-led treatments improve medication use and help manage bleeding risks. This involvement also leads to better control of blood clotting and fewer major bleeding incidents and strokes. Additionally, more patients receive effective treatment when pharmacists are involved. This approach excels at maintaining patients' blood levels in the safe range, reducing stroke risk. Overall, pharmacist management of this therapy can greatly improve health outcomes for people with AF. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have atrial fibrillation and am not currently on blood thinners, but I can take them.

Written informed consent

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

Exclusion Criteria

Your blood pressure is very high and not well controlled.

Severe cognitive impairment (≥5 errors on the Short Portable Mental Status Questionnaire)

I have not had serious bleeding in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pharmacist-led OAC management or enhanced usual care for atrial fibrillation stroke prophylaxis

3 months

Regular visits to community pharmacies

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Periodic follow-up visits

Extension

Exploratory assessment of healthcare utilization and clinical outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Oral anticoagulant

Trial Overview 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.

How Is the Trial Designed?

Group I: Pharmacist Intervention Arm Experimental Treatment 1 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 Arm Active Control 1 Intervention

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

Oral anticoagulant is already approved in European Union, United States for the following indications:

Approved in European Union as Eliquis for:

• Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
• Treatment and prevention of deep vein thrombosis and pulmonary embolism

Approved in United States as Eliquis for:

• Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
• Treatment of deep vein thrombosis and pulmonary embolism
• Reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Pharmacist-managed anticoagulation services for warfarin therapy resulted in significantly lower healthcare costs, saving $647,024 compared to usual medical care, while also improving patient outcomes.

Patients managed by pharmacists experienced fewer adverse events, hospitalizations, and emergency department visits, along with better control of their INR levels, indicating enhanced safety and efficacy of the pharmacist-led approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health care expenditures and therapeutic outcomes of a pharmacist-managed anticoagulation service versus usual medical care. Hall, D., Buchanan, J., Helms, B., et al.[2013]

A pharmacist-managed anticoagulation service significantly reduced the number of adverse events requiring hospitalization compared to usual care, with only 3 events in the pharmacist group versus 14 in the usual care group.

After the pharmacist-managed service was discontinued, there was a notable increase in adverse events and hospitalizations, highlighting the effectiveness of coordinated anticoagulation management in reducing complications related to warfarin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in warfarin adverse events requiring patient hospitalization after implementation of a pharmacist-managed anticoagulation service. Locke, C., Ravnan, SL., Patel, R., et al.[2019]

A pharmacist-led self-management program for warfarin patients significantly improved quality of life in four out of five measured areas compared to standard physician-led management, indicating enhanced patient satisfaction and engagement.

Despite the improvements in quality of life, the self-management program maintained similar levels of anticoagulation control as the specialized clinic, with both groups spending comparable time in the therapeutic range.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial. Verret, L., Couturier, J., Rozon, A., et al.[2022]

A study involving 278 patients showed that pharmacist-managed anticoagulation clinics achieved a significantly higher percentage of time in the therapeutic INR range (81.8%) compared to doctor-managed clinics (69.8%), indicating better control of warfarin therapy.

Patients in the pharmacist-managed clinic also had fewer extreme subtherapeutic INR levels (5.17% vs. 7.05%), suggesting that pharmacist involvement can enhance patient safety and outcomes in anticoagulation management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pharmacist-based compared to doctor-based anticoagulation management in Qatar. Elewa, H., Jalali, F., Khudair, N., et al.[2017]

Newer anticoagulants like dabigatran, rivaroxaban, and apixaban are at least as effective as warfarin for preventing strokes in patients with atrial fibrillation, without the need for regular blood monitoring.

When treating older adults with atrial fibrillation, clinicians should consider factors such as patient tolerance, cost, adherence, and the absence of a reversal agent for these newer medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving beyond warfarin-are we ready? A Review of the efficacy and safety of novel anticoagulant agents compared to warfarin for the management of atrial fibrillation in older adults. Ogbonna, KC., Clifford, KM.[2013]

A pharmacist-led point-of-care (POC) INR clinic significantly improved the time in therapeutic range (TTR) for patients on warfarin, increasing it from 64.41% to 77.09%, based on a review of 119 patient charts.

This 12.68% improvement in TTR was statistically significant (P = 0.03), suggesting that POC clinics can enhance anticoagulation management in family medicine settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pharmacist-Led Point-of-Care INR Clinic: Optimizing Care in a Family Health Team Setting. Rossiter, J., Soor, G., Telner, D., et al.[2022]

A study involving 151 patients with atrial fibrillation showed that pharmacist-led warfarin management significantly improved the time in therapeutic range (TTR) and international normalized ratio (INR) levels compared to usual medical care, indicating enhanced anticoagulation control.

The involvement of pharmacists in the warfarin medication therapy adherence clinic led to higher acceptance of recommendations and an expanded therapeutic INR range, demonstrating the critical role pharmacists play in optimizing warfarin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Standardized Warfarin Treatment Protocol on Anticoagulant Effect: Comparison of a Warfarin Medication Therapy Adherence Clinic with Usual Medical Care. Aidit, S., Soh, YC., Yap, CS., et al.[2022]

In a study of 32,675 patients with atrial fibrillation, apixaban and dabigatran were found to significantly lower the risk of major or clinically relevant non-major bleeding compared to warfarin, indicating their safety as anticoagulants.

Rivaroxaban did not show a reduced bleeding risk compared to warfarin and was associated with a higher risk of gastrointestinal bleeding, while apixaban and dabigatran were linked to a lower risk of intracranial bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nationwide registry study to compare bleeding rates in patients with atrial fibrillation being prescribed oral anticoagulants. Halvorsen, S., Ghanima, W., Fride Tvete, I., et al.[2020]

Apixaban, an oral direct factor Xa inhibitor, has been approved in the EU for preventing venous thromboembolism (VTE) after hip or knee replacement surgeries, demonstrating its efficacy in reducing the risk of blood clots in these patients.

The drug is also undergoing phase III trials for preventing strokes in patients with atrial fibrillation, indicating its potential for broader applications in thrombotic disorders, although development for acute coronary syndromes has been halted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: first global approval. Watson, J., Whiteside, G., Perry, C.[2021]

Healthcare professionals (HCPs) and patients demonstrated satisfactory knowledge of bleeding risks associated with apixaban, with 96.1% of HCPs recognizing symptoms that require immediate attention and 71.2% of patients identifying abnormal bleeding as a significant side effect.

The study found that a significant majority of HCPs (97.8%) who received the Prescriber Guide utilized it in patient discussions, and 90.9% of patients who received the Patient Alert Card read it at least once, indicating effective distribution and utilization of these educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Mayall, S., Kahlon, R., Al-Dakkak, I., et al.[2021]

A clinical pharmacist managing anticoagulation therapy in a rural physician office significantly improved patient outcomes, with the percentage of patients maintaining therapeutic international normalized ratios (INR) rising from 37.6% under usual care to 57.8% in the pharmacist-managed clinic (P < .001).

Patient and provider satisfaction with the anticoagulation management service was extremely high, indicating that pharmacist-led case management is a safe and effective approach for monitoring outpatient anticoagulation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of 4 years of clinical pharmacist anticoagulation case management in a rural, private physician office. Ernst, ME., Brandt, KB.[2019]

A quality improvement program for anticoagulation management services (AMS) in community pharmacies was implemented successfully, involving 37 pharmacies and 222 patients, which led to significant improvements in clinical practices for managing atrial fibrillation patients on anticoagulants.

After 6 months, the quality indicator scores for vitamin K antagonists and direct oral anticoagulants increased by 12.5% and 9.9%, respectively, while pharmacists' knowledge scores also improved, indicating that the program effectively enhanced both practice quality and pharmacist education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticoagulation management services in community pharmacy: Feasibility of implementing a quality improvement programme through a practice-based research network. Chartrand, M., Lalonde, L., Cantin, A., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38097269/

Pharmacist-led interventions in optimising the use of oral ... Pharmacist-led interventions have successfully improved the use of OAC therapies in patients with AF, and effectively managed the bleeding risks.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12399581/

The role of pharmacists in the management of patients with ... In this study, pharmacist-led interventions improved time in therapeutic range, reduced major bleeding events and strokes, and increased ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551741125000373

Outcomes of pharmacist-led patient education on oral ... This review revealed that pharmacist-led patient education was particularly effective in cases of VKAs, while the outcomes in cases of DOACs were modest.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821461

Stroke Risk Reduction in Atrial Fibrillation Through ... Oral anticoagulation (OAC) therapy is widely available and highly effective for stroke risk reduction and improving survival in AF. However, ...

5. bjgpopen.org bjgpopen.org/content/8/2/BJGPO.2023.0113

Pharmacist-led interventions in optimising the use of oral ... Results Overall, 76.3% (n = 470) of patients with AF received OAC therapy, and of these, 63.4% received DOACs. Pharmacist-led interventions increased DOAC ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297543/

Pharmacy-Led Management of Atrial Fibrillation: Improving ... Pharmacist-Led interventions in optimising the use of oral anticoagulants in atrial fibrillation patients in the general practice in England ...