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Atrial Fibrillation (AF)PAUSEVirtualNCT06844227

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

An observational study of Atrial Fibrillation (AF), run by McMaster University at 10 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Atrial Fibrillation (AF)
How many people
1,780 participants
Where
10 sitesin 3 countries
Study dates
1 Dec 2021to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Overall, the study population chosen is justified because: (i) AF/flutter is the dominant clinical indication for anticoagulant therapy; (ii) it is homogenous, thereby optimizing generalizability of study results; and (iii) it allows patient-level comparisons of outcomes with controls from the BRIDGE and PAUSE trials which included AF/flutter (but excluded patients with a MHV or VTE).

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

James D Douketis, MD contact

905-522-1155 ext. 36178

jdouket@mcmaster.ca

Melanie St John contact

905-525-9140 ext. 21645

stjohm1@mcmaster.ca

10 sites in 3 countries

Canada5 sites, 5 recruiting

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

    Josh Nosel, 902-473-2520, joshua.nosel@nshealth.ca

    Sudeep Shivakumar, MD

    Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Michelle Zondag, 905-527-4233 ext. 43571, zondag@hhsc.ca

    Sam Schulman, MD

    Recruiting

  • St. Joesph's Healthcare

    Hamilton, Ontario, L8N 4A6

    Ralph Laurence Gaa, 905-325-1842, gaar@mcmaster.ca

    James D Douketis, MD

    Recruiting

  • Juravinski

    Hamilton, Ontario, L8V 1C3

    Erjona Kruja, 905-521-2100 ext. 43761, kruja@hhsc.ca

    Davide Matino, MD

    Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Samuel Hamilton, 613-737-8899 ext. 74113, samuelhamilton@ohri.ca

    Marc Carrier, MD

    Recruiting

Other trials in Canada

United States4 sites, 4 recruiting

  • Henry Ford

    Detroit, Michigan, 482032

    Beverly Stallings, 313-916-7747, bstalli1@hfhs.org

    Scott Kaatz, MD

    Recruiting

  • Endeavor Health - Northshore

    Evanston, Illinois, 60201

    Marisa Durante, (847) 503-6454, mdurante@northshore.org

    Alfonso Tafur, MD

    Recruiting

  • Northwell Health

    Great Neck, New York, 11021

    Kanta Ochani, (516) 600-1484, kochani@northwell.edu

    Alex Spyropoulos, MD

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Alesha Amin, 469.216.3746, alesha.amin@jefferson.edu

    Geno Merli, MD

    Recruiting

Other trials in United States

Greece1 site, 1 recruiting

  • Larissa University Hospital

    Larissa, Larisa, 413 34

    Maria Ntalouka, 30-241-350-1000, maria.ntalouka@icloud.com

    Eleni Arnaoutoglou, MD

    Recruiting

Other trials in Greece

About this study

Official title: Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual), a Simple Perioperative Anticoagulant Management Approach, Replacing a Resource-intensive In-person Doctor-patient Consultation, With a Simple Virtual Care Model That Will Provide a New Standard of Care for Patients on a Direct Oral Anticoagulant or Warfarin and Require Elective Surgery/Procedure.

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.

Read the detailed description

The Clinical Problem: The management of patients who are taking warfarin or a direct oral anticoagulant (DOAC) and need an elective surgery/procedure is a common and important clinical problem: (i) ~200,000 patients/yr are assessed in Canada for such management and this will increase due to an ageing population and an increase in anticoagulant use; and (ii) if anticoagulants are not managed carefully, with evidence-based protocols, patients can be exposed to an increased risk for disabling stroke if anticoagulant interruption is too long or life-threatening bleeding if interruption is too short.

The Healthcare Delivery Problem: Perioperative management of anticoagulant therapy has been traditionally done in an in-person setting where patients receive instructions about when to stop and restart anticoagulants and, if needed, to receive teaching to self-administer heparin bridging. The COVID pandemic has upended this healthcare delivery model, necessitating virtual management by phone/video. Virtual patient care to manage perioperative anticoagulation has the potential to be an efficient and patient-friendly standard post-pandemic. However, to attain this objective, it must be reliably shown that virtually-administered, standardized, perioperative anticoagulation management is: (i) safe, with acceptably low rates of stroke and bleeding; (ii) easy to apply in practice; and (iii) acceptable to patients.

The foundation for this study is based on prior work by the investigator: (i) The investigator has led multicenter clinical trials (BRIDGE, PAUSE) that provide benchmarks for safe perioperative management of patients who are receiving warfarin or a DOAC; (ii) the management protocols from these trials were incorporated into a clinical decision tool that is available (cost-free) by Thrombosis Canada (www.thrombosiscanada.ca). This point-of-care app allows input of patient-specific information to manage individual patients with atrial fibrillation/flutter (AF) who are receiving warfarin or a DOAC and require an elective surgery/procedure. At the end of the assessment, a care-path summary is available as a PDF for clinicians and patients for downloading and printing.

The Opportunity: The pandemic has necessitated the adoption of virtual perioperative anticoagulant management but also has provided the opportunity to re-evaluate how such care can be safely delivered. Given that (i) perioperative anticoagulant interruption/resumption and heparin bridging protocols are standardized, and (ii) there is an easy-to-use, point-of-care, management app available, the investigator has a unique opportunity to apply evidence-informed protocols with user-friendly knowledge translation tools to assess the safety and acceptability to patients of virtual perioperative anticoagulant management.

The Solution: A prospective cohort study (non-RCT) assessing standardized virtual perioperative management in 2 cohorts of patients on warfarin or a DOAC who require an elective surgery/procedure.

Hypothesis \& Postulates: (i) the investigator hypothesizes that virtual perioperative management will be safe for patient care, with 30-day postoperative rates of stroke/systemic embolism (SSE) ≤0.5% and major bleeding (MB) ≤1.5%. With a sample size of 847 patients in Cohort 1 and in Cohort 2, the investigator will have 90% power at the 95% level of significance to reject the null hypothesis that the observed rates are ≥1.5% for SSE and ≥3% for MB in each cohort. (ii) The investigator postulates (a) that virtual management will be as safe as in matched historical control groups who received benchmark in-person management, (b) that virtual management will reduce healthcare costs and costs to patients, and (c) that patients will be satisfied with virtual management and will be willing to receive this methods of healthcare delivery post-pandemic.

Significance: PAUSE-Virtual will shift perioperative anticoagulant management from a resource-intensive in-person model to a patient-friendly virtual model, establishing a standard-of-care option for 200,000 patients/yr in Canada. The investigator is a leading group in perioperative anticoagulant management worldwide, having done the landmark BRIDGE1 and PAUSE2 trials. There is no other research group (that the investigator knows of) that will do this trial, and it will not be funded by industry (no commercial interest).

Keywords
anticoagulation, Atrial Fibrillation, Surgery, Oral Anticoagulant, Blood Thinner, DOAC, Interruption, Perioperative, Virtual, PAUSE
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06844227
Study groupRoleWhat they receive
Cohort 1: warfarin-treated patientsCohort 1: warfarin-treated patients with AF who receive virtual perioperative management
Cohort 2: DOAC-treated patientsCohort 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome

    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.

    Measured: From enrollment to end of 30 day follow up

Secondary outcomes (2)

  1. Secondary Outcome 1

    To demonstrate that virtual management is safe, as defined by 30-day postoperative rates of stroke/systemic embolism (SSE) of ≤0.5% and major bleeding (MB) of ≤1.5% with ability to exclude rates of SSE and MB of 1.5% and 3.0%, with a sample of 847 patients in Cohorts 1 and 2, the investigator will have 90% power at the 95% level of significance to reject the null hypothesis that the observed rate of SSE is ≥1.5% and MB is ≥3.0%. This sample size of 847 is increased by 5% to 890 patients per Cohort (1,780 total) to account for cancelled surgeries/procedures and patients lost to follow-up.

    Measured: From enrollment to end of 30 day follow up

  2. Secondary Outcome 2

    The investigator will determine the cost effectiveness of the virtual management compared with in-person care from both public payer and societal perspectives. Health resource use will be collected alongside the clinical data collection that includes physician, nursing and pharmacist consultation time, medication, diagnostics and procedures, and hospitalization. Patient's time and travel costs will also be included in the analysis from the societal perspective. Incremental cost effectiveness ratio between each of the cohort and corresponding control group will be calculated. 95% confidence interval of the ratio will be estimated using non-parametric bootstrapping approach. Cost effectiveness acceptability curves will be used to show the probability of virtual care being cost effective compared with in person care over a wide range of willingness-to-pay values.

    Measured: From enrollment to end of 30 day follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start1 Dec 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06844227
Sponsor's protocol ID
PAUSE Virtual (CTO 3854)
Other IDs
202104PJT-461879-CID-CEBA-5761
Acronym
PAUSEVirtual
Status last verified
Nov 2024
First submitted
25 Nov 2024
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD data will be shared. All data reported as part of the study is aggregate data.

Publications

  • Jamula E, Woods K, Verhovsek M, Douketis JD, McDonald E. Comparison of pain and ecchymosis with low-molecular-weight heparin vs. unfractionated heparin in patients requiring bridging anticoagulation after warfarin interruption: a randomized trial. J Thromb Thrombolysis. 2009 Oct;28(3):266-8. doi: 10.1007/s11239-009-0312-8. Epub 2009 Feb 14.

    PubMed 19219405

  • Brown SD, Lee K, Schoffman DE, King AC, Crawley LM, Kiernan M. Minority recruitment into clinical trials: experimental findings and practical implications. Contemp Clin Trials. 2012 Jul;33(4):620-3. doi: 10.1016/j.cct.2012.03.003. Epub 2012 Mar 16.

    PubMed 22449836

  • Clark LT, Watkins L, Pina IL, Elmer M, Akinboboye O, Gorham M, Jamerson B, McCullough C, Pierre C, Polis AB, Puckrein G, Regnante JM. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019 May;44(5):148-172. doi: 10.1016/j.cpcardiol.2018.11.002. Epub 2018 Nov 9.

    PubMed 30545650

  • Amorrortu RP, Arevalo M, Vernon SW, Mainous AG 3rd, Diaz V, McKee MD, Ford ME, Tilley BC. Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach. Trials. 2018 Feb 17;19(1):115. doi: 10.1186/s13063-018-2507-9.

    PubMed 29454389

  • Shaw JR, Zhang T, Le Gal G, Douketis J, Carrier M. Perioperative interruption of direct oral anticoagulants and vitamin K antagonists in patients with atrial fibrillation: A comparative analysis. Res Pract Thromb Haemost. 2020 Jan 20;4(1):131-140. doi: 10.1002/rth2.12285. eCollection 2020 Jan.

    PubMed 31989095

  • Skeith L, Taylor J, Lazo-Langner A, Kovacs MJ. Conservative perioperative anticoagulation management in patients with chronic venous thromboembolic disease: a cohort study. J Thromb Haemost. 2012 Nov;10(11):2298-304. doi: 10.1111/j.1538-7836.2012.04907.x.

    PubMed 22925003

  • Cahill TJ, Chen M, Hayashida K, Latib A, Modine T, Piazza N, Redwood S, Sondergaard L, Prendergast BD. Transcatheter aortic valve implantation: current status and future perspectives. Eur Heart J. 2018 Jul 21;39(28):2625-2634. doi: 10.1093/eurheartj/ehy244.

    PubMed 29718148

  • Isaacs AJ, Shuhaiber J, Salemi A, Isom OW, Sedrakyan A. National trends in utilization and in-hospital outcomes of mechanical versus bioprosthetic aortic valve replacements. J Thorac Cardiovasc Surg. 2015 May;149(5):1262-9.e3. doi: 10.1016/j.jtcvs.2015.01.052. Epub 2015 Feb 11.

    PubMed 25791947

  • Andrade JG, Aguilar M, Atzema C, Bell A, Cairns JA, Cheung CC, Cox JL, Dorian P, Gladstone DJ, Healey JS, Khairy P, Leblanc K, McMurtry MS, Mitchell LB, Nair GM, Nattel S, Parkash R, Pilote L, Sandhu RK, Sarrazin JF, Sharma M, Skanes AC, Talajic M, Tsang TSM, Verma A, Verma S, Whitlock R, Wyse DG, Macle L; Members of the Secondary Panel. The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation. Can J Cardiol. 2020 Dec;36(12):1847-1948. doi: 10.1016/j.cjca.2020.09.001. Epub 2020 Oct 22.

    PubMed 33191198

  • Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. Gender-related differences in risk of cardiovascular morbidity and all-cause mortality in patients hospitalized with incident atrial fibrillation without concomitant diseases: a nationwide cohort study of 9519 patients. Int J Cardiol. 2014 Nov 15;177(1):91-9. doi: 10.1016/j.ijcard.2014.09.092. Epub 2014 Oct 11.

    PubMed 25499348

  • Pancholy SB, Sharma PS, Pancholy DS, Patel TM, Callans DJ, Marchlinski FE. Meta-analysis of gender differences in residual stroke risk and major bleeding in patients with nonvalvular atrial fibrillation treated with oral anticoagulants. Am J Cardiol. 2014 Feb 1;113(3):485-90. doi: 10.1016/j.amjcard.2013.10.035. Epub 2013 Nov 11.

    PubMed 24315113

  • McAlister FA, Garrison S, Kosowan L, Ezekowitz JA, Singer A. Use of Direct Oral Anticoagulants in Canadian Primary Care Practice 2010-2015: A Cohort Study From the Canadian Primary Care Sentinel Surveillance Network. J Am Heart Assoc. 2018 Jan 26;7(3):e007603. doi: 10.1161/JAHA.117.007603.

    PubMed 29374047

  • Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.

    PubMed 24345399

  • Czeisler ME, Marynak K, Clarke KEN, Salah Z, Shakya I, Thierry JM, Ali N, McMillan H, Wiley JF, Weaver MD, Czeisler CA, Rajaratnam SMW, Howard ME. Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020 Sep 11;69(36):1250-1257. doi: 10.15585/mmwr.mm6936a4.

    PubMed 32915166

  • Woolf SH, Chapman DA, Sabo RT, Weinberger DM, Hill L. Excess Deaths From COVID-19 and Other Causes, March-April 2020. JAMA. 2020 Aug 4;324(5):510-513. doi: 10.1001/jama.2020.11787.

    PubMed 32609307

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF), run by McMaster University at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada, United States, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact James D Douketis, MD (905-522-1155 ext. 36178, jdouket@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome (time frame: From enrollment to end of 30 day follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06844227, which also lists 89 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.

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