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Search / Trial NCT06844227

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

Launched by MCMASTER UNIVERSITY · Feb 19, 2025

Trial Information

Current as of June 10, 2025

Recruiting

Keywords

Anticoagulation Atrial Fibrillation Surgery Oral Anticoagulant Blood Thinner Doac Interruption Perioperative Virtual Pause

ClinConnect Summary

The PAUSE-Virtual study is exploring a new way to manage patients who take blood thinners and need elective surgery. Normally, patients would meet their doctors in person to discuss when to stop and restart their medications before surgery, which is important to prevent complications like strokes or bleeding. This study is testing whether these pre-surgery consultations can be just as safe and effective if done virtually, through phone calls or video chats. Researchers want to find out if this virtual approach is easy for patients to use and whether it keeps them safe from serious risks.

To be eligible for the study, participants must be at least 18 years old and have a condition called atrial fibrillation, which requires them to take blood thinners like warfarin or certain newer medications. They also need to have a planned surgery that isn’t urgent. If someone chooses to participate, they will receive guidance about their medication through virtual visits instead of in-person appointments. This study aims to show that virtual care can be a safe and convenient option for managing anticoagulant therapy, especially in today’s healthcare environment.

Gender

ALL

Eligibility criteria

  • 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

About Mcmaster University

McMaster University, a leading research institution located in Hamilton, Ontario, Canada, is renowned for its innovative approach to education and its commitment to advancing healthcare through rigorous clinical research. The university's diverse research programs are supported by a multidisciplinary team of experts dedicated to improving patient outcomes and public health. With a strong emphasis on evidence-based medicine, McMaster University actively engages in clinical trials that explore new therapies, interventions, and health technologies, fostering collaboration among researchers, healthcare professionals, and industry partners to translate findings into real-world applications.

Locations

Philadelphia, Pennsylvania, United States

Hamilton, Ontario, Canada

Halifax, Nova Scotia, Canada

Hamilton, Ontario, Canada

Great Neck, New York, United States

Ottawa, Ontario, Canada

Evanston, Illinois, United States

Detroit, Michigan, United States

Hamilton, Ontario, Canada

Larisa, , Greece

Patients applied

0 patients applied

Trial Officials

James D Douketis, MD

Principal Investigator

McMaster University/St. Joseph's Healthcare

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported