Recruiting

Anticoagulant Management

Sponsor:

McMaster University

Code:

NCT06844227

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of the PAUSE-Virtual Study is to show that by changing pre-surgery visits with patients taking a blood thinner (direct oral anticoagulant (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) when the participant requires elective surgery, using a standard, in-person proven approach, to a virtual visit, either telephone or video conference, is as safe. Patients who are receiving a blood thinner for the medical condition known as atrial fibrillation (AF) and require an elective surgery/procedure, is common. These patients have to stop taking their blood thinner for a certain time before the procedure to reduce serious complications of stroke or bleeding. For doctors who help manage these patients before a procedure, appointments have been traditionally done in-person. Patients receive instructions about when to stop and restart their blood thinners and taught how to self-administrator a short acting blood thinner (heparin) if needed. The COVID pandemic changed the way these appointments were done, making it important to contact these patients without them having to come to the hospital for an in person visit. Virtual patient care, by telephone or video conference, to communicate to patients about when to start and restart their blood thinner was necessary. This study wants to show that this virtual method of instruction, using a standardized plan of managing patient care, is easy, acceptable to patients and as safe when compared to an in-person meeting. Such instruction would also be cost-efficient standard post-pandemic. Prior work has shown that both a standard care of patients who are receiving blood thinners and a point-of-care decision "app", available through Thrombosis Canada (www.thrombosiscanada.ca) website, have been trusted during this virtual visit successfully. The investigator will show, by following up at 30 days, that this standardized management plan is safe and can be done virtually, with a low risk of stroke and major bleeding.

Conditions

Atrial Fibrillation (AF)

Study ID

NCT06844227

Start date

Dec 1, 2021

Status verified date

Nov, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

1780 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

  • Primary Outcome [ Time Frame: From enrollment to end of 30 day follow up ]

Central Contacts and Locations

Central contacts

Locations

Endeavor Health - Northshore

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Principal Investigator:

Alfonso Tafur, MD

Henry Ford

Recruiting

Detroit, Michigan, United States, 482032

Contacts

Principal Investigator:

Scott Kaatz, MD

Northwell Health

Recruiting

Great Neck, New York, United States, 11021

Contacts

Principal Investigator:

Alex Spyropoulos, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

Geno Merli, MD

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

Principal Investigator:

Sudeep Shivakumar, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Principal Investigator:

Sam Schulman, MD

St. Joesph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Principal Investigator:

James D Douketis, MD

Juravinski

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contacts

Principal Investigator:

Davide Matino, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Principal Investigator:

Marc Carrier, MD

More Information

Sponsor

McMaster University

Last update posted

Mar 10, 2025

Last verified

Nov, 2024

Keywords

  • anticoagulation
  • Atrial Fibrillation
  • Surgery
  • Oral Anticoagulant
  • Blood Thinner
  • DOAC
  • Interruption
  • Perioperative
  • Virtual
  • PAUSE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by McMaster University on 2025-03-10.