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PAUSE-Virtual Study: Virtual Visits for Blood Thinner Management Before Surgery

The PAUSE-Virtual study is looking at whether virtual visits (by phone or video) are as safe as in-person visits for managing blood thinners like warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban before elective surgery. This study is for people aged 18 to 100 who have atrial fibrillation (AF), a heart condition, and are taking these blood thinners. When you need surgery, you usually have to stop taking your blood thinner for a short time to prevent serious problems like stroke or bleeding. Traditionally, these pre-surgery appointments have been in-person. This study aims to see if virtual visits can be just as safe and effective. The study plans to enroll 1780 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving specific interventions. It aims to enroll 1780 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment until 30 days after the study ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06844227

Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual)

Recruiting
Not specifiedAges 18+Observational
McMaster University
~1,780 participants
Updated 2025-03-10 on ClinicalTrials.gov

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome
Measured over From enrollment to end of 30 day follow up

Conditions

Atrial Fibrillation (AF)

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Atrial Fibrillation

NCT06844227

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Endeavor Health - Northshore

    Evanston, Illinoisstudy coordinator listed

    Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, Canadastudy coordinator listed

    Recruiting

  • Henry Ford

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Juravinski

    Hamilton, Ontario, Canadastudy coordinator listed

    Recruiting

  • Larissa University Hospital

    Larissa, Larisa, Greecestudy coordinator listed

    Recruiting

  • Northwell Health

    Great Neck, New Yorkstudy coordinator listed

    Recruiting

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, Canadastudy coordinator listed

    Recruiting

  • St. Joesph's Healthcare

    Hamilton, Ontario, Canadastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • James D Douketis, MD · PRINCIPAL_INVESTIGATOR · McMaster University/St. Joseph's Healthcare

Who to contact

James D Douketis, MD
[email protected]
905-522-1155 · ext. 36178
Email the study team

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Eligibility criteria

Inclusion

Age 18 years of age or older with AF/flutter (chronic, persistent, paroxysmal) that requires anticoagulation
Receiving warfarin, with a target international normalized ratio (INR) range of 2.0-3.0, or a DOAC, comprising one of the following regimens: apixaban, 2.5 mg or 5 mg bid; edoxaban, 30 mg or 60 mg daily; dabigatran, 110 mg or 150 mg bid; or rivaroxaban, 15 mg or 20 mg daily
Require an elective (planned, non-urgent) surgery or invasive medical or surgical procedure

Exclusion

Indication for anticoagulation is not AF/flutter (e.g., mechanical heart valve, VTE, other)
Non-standard anticoagulant regimen used (e.g., warfarin INR 3-4, rivaroxaban 2.5 mg bid)
In DOAC users only: creatinine clearance \<25 mL/min (that preclude DOAC use)
Cognitive impairment or psychiatric illness (that precludes reliable contact during follow-up)
Unable or unwilling to provide consent for virtual care (in-person care will be provided)
Previous participation in this study for an elective surgery/procedure

What this trial measures

  • Primary OutcomeFrom enrollment to end of 30 day follow up

    The investigator will determine 30-day post-procedure event rates with 95% confidence interval (CIs) for stroke/systemic embolism (SSE), major bleeding (MB) and, with a one-sided binomial test, will determine in Cohort 1 and Cohort 2 if the SSE rate is lower than 1.5%, and the MB rate is lower than 3%. The investigator will compare patient demographic (e.g., age, gender) and clinical characteristics (e.g., surgery type, SSE/MB risk) in Cohort 1 vs. Control 1 and Cohort 2 vs. Control 2 using Fisher's exact test, respectively, so as to compare SSE and MB in Cohorts and Controls, adjusting for key covariates (e.g., surgery type, anticoagulant type, gender) using multivariate logistic regression. The investigator will determine the proportions (and 95% CIs) for patient satisfaction categories in virtual care and willingness to receive future virtual care.