Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

NCT ID: NCT03126214

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2023-12-01

Brief 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.

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).

Conditions

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Pharmacist Arm

OAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation.

Group Type: EXPERIMENTAL

Anticoagulants

Intervention Type: DRUG

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

Enhanced Usual Care Arm

Pharmacist 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

Group Type: ACTIVE_COMPARATOR

Anticoagulants

Intervention Type: DRUG

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

Interventions

Anticoagulants

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

Intervention Type: DRUG

Other Intervention Names

warfarin and novel oral anticoagulants

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).
• 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

Canadian Stroke Prevention Intervention Network

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roopinder Sandhu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39046741 (View on PubMed)

Other Identifiers

0024466

Identifier Type: -

Identifier Source: org_study_id