1780 Participants Needed

Virtual Visits for Atrial Fibrillation

(PAUSEVirtual Trial)

Recruiting at 10 trial locations
JD
MS
Overseen ByMelanie St John
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
Must be taking: Blood thinners
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual visits are as safe as in-person visits for patients with atrial fibrillation (AF) who need to stop taking blood thinners before elective surgery. The goal is to determine if instructions given through phone or video calls can effectively help patients manage their medication without increasing the risk of stroke or bleeding. This approach could offer more convenience and cost savings for patients. Individuals with AF on specific blood thinners, such as warfarin or other direct oral anticoagulants (DOACs), who require planned surgery might be suitable candidates for this trial.

As a Phase 3 trial, this study represents the final step before FDA approval, providing patients an opportunity to contribute to a potentially groundbreaking treatment approach.

Why are researchers excited about this trial?

Researchers are excited about the PAUSE-Virtual trial because it explores a new way of managing anticoagulant use around the time of surgery using virtual visits. Unlike traditional in-person consultations, this method leverages virtual technology to monitor and adjust anticoagulant therapy, potentially offering greater convenience and flexibility for both patients and healthcare providers. This approach could lead to more personalized and timely care, reducing the risk of complications associated with anticoagulant use during surgery. By integrating technology into patient care, this trial aims to enhance patient outcomes and streamline the management process.

Who Is on the Research Team?

JD

James D Douketis, MD

Principal Investigator

McMaster University/St. Joseph's Healthcare

Are You a Good Fit for This Trial?

Inclusion Criteria

I need a planned surgery that is not an emergency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (virtual)

Virtual Preoperative Management

Participants receive virtual instructions on when to stop and restart anticoagulants and, if needed, how to self-administer heparin bridging

1-2 weeks
1-2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, focusing on stroke/systemic embolism and major bleeding rates

4 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

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Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
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Recruited
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