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Atrial FibrillationPhase 4PIAAFRxNCT03126214

Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

A Phase 4 study testing Anticoagulants in people with Atrial Fibrillation and Stroke, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the effectiveness of prescribing oral anticoagulation therapy by pharmacist intervention compared to enhanced usual care in participants with unrecognized AF and/or known AF but not taking blood thinners. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Atrial Fibrillation, Stroke
What is being tested?
Anticoagulants
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteCanada
Study dates
1 Feb 2018to 1 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 65 years with one additional stroke risk factor (hypertension, diabetes, heart failure history of or left ventricular ejection fraction <0.40), previous stroke or transient ischemic attack).
  • Atrial fibrillation and not on oral anticoagulation (OAC) therapy but eligible
  • Atrial fibrillation on sub-optimal OAC

Who cannot join

  • Uncontrolled hypertension (defined as average SBP ≥ 160 mmHg [2 readings taken at time of screening]).
  • End stage renal disease (CrCl < 15 ml/min)
  • Valvular Heart Disease including those with prosthetic valve, mitral stenosis (moderate to severe) or valve repair.
  • Excess alcohol intake (males: ≥ 28 units/week, females: ≥ 21 units/week. One unit of alcohol = 8 oz beer, 1 oz hard liquor or 4 oz wine).
  • Intracranial bleed at any point.
  • History of "Major Bleeding" at any point (defined as overt bleeding at a critical site including intracranial, intraspinal, intraocular, pericardial, or retroperitoneal; or bleed requiring hospitalization).
Show all 9Show fewer
  • Foreshortened life-expectancy or severe comorbidities precluding study follow-up period
  • Unable to read/understand English
  • Severe cognitive impairment (defined as score ≥ 5 on the Short Portable Mental Status Questionnaire)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2E1

Other trials in Canada

About this study

Official title: Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing: Program for the Identification of 'Actionable' AF (PIAAF) Rx Study

The purpose of this study is to compare the effectiveness of prescribing oral anticoagulation therapy by pharmacist intervention compared to enhanced usual care in participants with unrecognized AF and/or known AF but not taking blood thinners.

Read the detailed description

Background:

AF is the most common arrhythmia and the leading cause of stroke. Despite robust evidence oral anticoagulation (OAC) therapy is effective and safe for stroke prevention in patients with AF; there is a lack of real-world application. Alternative strategies to deliver stroke prevention therapy need to be explored. Although pharmacists' prescribing of antihypertensive and lipid lowering drug therapy has been shown to increase adherence to guideline-based targets and warfarin management improve control of international normalized ratios in anticoagulation clinics, the role of pharmacist initiation of OAC therapy compared to usual care in AF patients for stroke prevention in a community setting is unclear.

In this study, the investigators will screen participants presenting to community pharmacies to identify participants with unrecognized AF and/or known AF but not taking blood thinners or not on optimal OAC therapy and randomize care to either the pharmacist or enhanced usual care (family physician notification by pharmacist).

Being tested
Anticoagulants
Keywords
atrial fibrillation, stroke, oral anticoagulation therapy, pharmacist case management
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnticoagulantsDrug

    Also called warfarin and novel oral anticoagulants

    Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation.

Study groups in NCT03126214
Study groupRoleWhat they receive
Active Pharmacist ArmExperimentalOAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation.
Receives: Drug: Anticoagulants
Enhanced Usual Care ArmActive comparatorPharmacist will be refer participants to their physician in regards to OAC therapy for atrial fibrillation. The pharmacist will provide a current medication list to the physician as well as notification of a new diagnosis of atrial fibrillation
Receives: Drug: Anticoagulants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention

    Proportion of participants receiving optimal OAC therapy in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation in the early intervention arm compared to the delayed intervention arm. Optimal defined as a new prescription for OAC in a previously untreated AF or known AF who should be on an OAC or adjustment of an existing OAC prescription.

    Measured: 3 months

Secondary outcomes (5)

  1. Prevalence of AF

    To determine the prevalence of participants with unrecognized AF eligible for OAC therapy and those with AF who should be on OAC therapy but are either not on or their existing OAC prescriptions; require adjustment due to contraindications, or sub-optimal levels (hereafter referred to those with "actionable" AF)

    Measured: Through study completion, an average of 1 year

  2. Patient Satisfaction with Pharmacists Services

    Assessed using the validated Participant Satisfaction with Pharmacists Services Questionnaire (consists of 22 questions with 4 point Likert scale).

    Measured: 3 months

  3. Qualitative Assessment of Implementation by Pharmacist

    Assessed using the questionnaire developed by the SEARCH-AF study

    Measured: Through study completion, an average of 1 year

  4. Healthcare Utilization

    To determine the number of hospital, emergency department and physician visits related to AF

    Measured: One year

  5. Healthcare Utilization

    To determine the number of laboratory testing performed related to oral anticoagulation therapy

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start1 Feb 2018
  3. Primary completion1 Jul 2022
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Prospective, open-label, randomized, stepped wedge trial design. Participants will be randomized to "early" (day 0-90) versus "delayed" pharmacist intervention (starting day 90-180).
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126214
Sponsor's protocol ID
0024466
Acronym
PIAAFRx
Status last verified
Jan 2024
First submitted
12 Apr 2017
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sandhu RK, Fradette M, Lin M, Youngson E, Lau D, Bungard TJ, Tsuyuki RT, Dolovich L, Healey JS, McAlister FA. Stroke Risk Reduction in Atrial Fibrillation Through Pharmacist Prescribing: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2421993. doi: 10.1001/jamanetworkopen.2024.21993.

    PubMed 39046741

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anticoagulants in people with Atrial Fibrillation and Stroke, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126214, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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