NCT06844227 Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual)
| NCT ID | NCT06844227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Atrial Fibrillation (AF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,780 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,780 participants in total. It began in 2021-12-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
James D Douketis, MD
PRINCIPAL INVESTIGATOR
McMaster University/St. Joseph's Healthcare
Frequently Asked Questions
Who can join the NCT06844227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06844227 currently recruiting?
Yes, NCT06844227 is actively recruiting participants. Contact the research team at jdouket@mcmaster.ca for enrollment information.
Where is the NCT06844227 trial being conducted?
This trial is being conducted at Evanston, United States, Detroit, United States, Great Neck, United States, Philadelphia, United States and 6 additional locations.
Who is sponsoring the NCT06844227 clinical trial?
NCT06844227 is sponsored by McMaster University. The principal investigator is James D Douketis, MD at McMaster University/St. Joseph's Healthcare. The trial plans to enroll 1,780 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.