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PAUSEVirtualNCT06844227

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

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from McMaster University

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2025 to Dec 31, 2026 Show 5 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised at 5 of 10 sites
    • Publications: details revised at 84 of 89 entries
  2. Eligibility criteria shortened, about 9 wordsv2 Show 5 more changesShow less
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site contacts updated at 10 of 10 sites
    • Publications: details revised at 89 of 89 entries
    • Study title shortened, about 18 words
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Primary Outcome
Timeframe: From enrollment to end of 30 day follow up

Secondary (2)

Secondary Outcome 1
Secondary Outcome 2

Arms and interventions

Cohort 1: warfarin-treated patients

Cohort 1: warfarin-treated patients with AF who receive virtual perioperative management

Cohort 2: DOAC-treated patients

Cohort 2: DOAC-treated patients with AF who receive virtual perioperative management. Using this design, the investigator aims to show in Cohorts 1 and 2 that virtual management is non-inferior to benchmark in-person management, defined by 30-day postoperative rates of SSE ≤0.5% (with 95% confidence to exclude 1.5% rate) and MB ≤1.5% (with 95% confidence to exclude 3% rate).

Sites

10 sites in 3 countries

Canada 5, United States 4, Greece 1