Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure

NCT06957366 | Recruiting DMC

• 1 other identifier: PAUSE 2 RCT (CTO 4938)
• Study Type: interventional
• Target: 920
• Locations: 4 countries
• Sites: 14

Brief Summary

PAUSE 2 study is a prospective, open-label, blinded-endpoint non-inferiority RCT of PAUSE vs. ASRA management in DOAC treated high risk patients with AF/VTE who need elective high bleed risk surgery/procedure and/or any procedure involving neuraxial anesthesia. The purpose of the PAUSE 2 study is to show that PAUSE management will be as safe (i.e., non-inferior) as ASRA management, with 95% of patients having low/undetectable pre-operative DOAC levels \<30 ng/mL in each group., at the time of surgery/neuraxial.

Conditions

Atrial Fibrillation (AF); VTE

Keywords

anticoagulation; atrial Fibrillation; Surgery; Oral Anticoagulant; Blood thinner; DOAC; VTE; Interruption; PAUSE

Outcome Measures

Primary Outcomes (1)

• Proportion of patients randomized to each study arm with a residual pre-operative DOAC level < 30 ng/mL

  The primary outcome in PAUSE-2 will be the proportion of patients with a residual pre-operative DOAC level \< 30 ng/mL. Pre-operative DOAC levels will be measured using calibrated anti-Xa assays for direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and will be measured using a dilute thrombin time assay for dabigatran-treated patients.

  Day 1

Secondary Outcomes (8)

• Proportion of patients with a residual pre-operative DOAC level < 50 ng/mL.

  Day 1

• Clinically relevant nonmajor bleeding

  Day 28

• Arterial thromboembolic Events (ATE)

  Day 28

• Major bleeding

  Day 28

• Minor bleeding

  Day 28

Study Arms (4)

Apixaban

ACTIVE COMPARATOR

Patients currently taking Apixaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

Other: PAUSE Perioperative DOAC Management; Other: ASRA Perioperative DOAC Management

Dabigatran

ACTIVE COMPARATOR

Patients currently taking Dabigatran that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

Other: PAUSE Perioperative DOAC Management; Other: ASRA Perioperative DOAC Management

Rivaroxaban

ACTIVE COMPARATOR

Patients currently taking Rivaroxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

Other: PAUSE Perioperative DOAC Management; Other: ASRA Perioperative DOAC Management

Edoxaban

ACTIVE COMPARATOR

Patients currently taking Edoxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

Other: PAUSE Perioperative DOAC Management; Other: ASRA Perioperative DOAC Management

Interventions

PAUSE Perioperative DOAC Management OTHER

PAUSE management is simple and easy to apply as patients having a high-bleed-risk surgery/neuraxial procedure interrupt DOACs for 2 days before and 2 days after surgery without heparin bridging or DOAC level testing.

Apixaban; Dabigatran; Edoxaban; Rivaroxaban

ASRA Perioperative DOAC Management OTHER

ASRA management is more complex, requiring 72-120 hours DOAC interruption and, in selected patients, pre-operative heparin bridging and DOAC level testing.

Apixaban; Dabigatran; Edoxaban; Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, age 18 years of age or greater, with AF/flutter (permanent, persistent or paroxysmal) or VTE (leg deep vein thrombosis or pulmonary embolism) that require a full (therapeutic)-dose DOAC regimen, appropriate for age and renal function, comprising one of (a) apixaban 2.5 mg or 5 mg bid; (b) dabigatran 110 mg or 150 mg bid; (c) edoxaban 30 mg or 60 mg daily; or (d) rivaroxaban 15 mg or 20 mg daily
• High-risk patient having an elective high-bleed-risk surgery or any elective surgery with neuraxial anesthesia (epidural, spinal, regional) or any deep nerve root block.

You may not qualify if:

• Indication for anticoagulation is unusual site thrombosis (e.g. splanchnic, cerebral, sinus, arm)
• Receiving a low-dose DOAC regimen used for secondary VTE prevention (e.g. rivaroxaban 10 mg daily, apixaban 2.5 mg bid) or another low-dose DOAC regimen (e.g. rivaroxaban 2.5 mg bid)
• CrCL\<25mL/min (if on apixaban, edoxaban, rivaroxaban) or \<30 mL/min (if on dabigatran)
• cognitive impairment or psychiatric illness that precludes reliable contact during follow up.
• Unable or unwilling to provide consent
• Previous participation in PAUSE 2

Sponsors & Collaborators

• McMaster University: lead

Study Sites (14)

Hartford Health Care

Hartford, Connecticut, 06106, United States

NOT YET RECRUITING

North Shore University Health

Evanston, Illinois, 60201, United States

NOT YET RECRUITING

Brigham and Woman's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Henry Ford Health Care

Detroit, Michigan, 48202, United States

NOT YET RECRUITING

Northwell Health System

New York, New York, 10305, United States

NOT YET RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

University of Leuven

Leuven, Belgium, Belgium

NOT YET RECRUITING

Winnipeg Health Sciences Center

Winnipeg, Manitoba, Canada

NOT YET RECRUITING

St. Joesph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Juravinski

Hamilton, Ontario, Canada

NOT YET RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

L'Hospital Montfort

Ottawa, Ontario, Canada

NOT YET RECRUITING

Toronto General Hospital

Toronto, Ontario, Canada

NOT YET RECRUITING

University of Thessaly

Larissa, Greece, Greece

NOT YET RECRUITING

Related Publications (46)

• Shaw JR, Unachukwu U, Cyr J, Siegal DM, Castellucci LA, Dreden PV, Dowlatshahi D, Buyukdere H, Ramsay T, Carrier M. Effect of PCC on Thrombin Generation among Patients on Factor Xa Inhibitors with Major Bleeding or Needing Urgent Surgery (GAUGE): Design and Rationale. TH Open. 2023 Jul 25;7(3):e229-e240. doi: 10.1055/s-0043-1771300. eCollection 2023 Jul.

  PMID: 37497426 BACKGROUND

• Shaw JR, Castellucci LA, Siegal D, Carrier M. DOAC-associated bleeding, hemostatic strategies, and thrombin generation assays - a review of the literature. J Thromb Haemost. 2023 Mar;21(3):433-452. doi: 10.1016/j.jtha.2022.11.029. Epub 2022 Dec 22.

  PMID: 36696204 BACKGROUND

• Harenberg J, Beyer-Westendorf J, Crowther M, Douxfils J, Elalamy I, Verhamme P, Bauersachs R, Hetjens S, Weiss C; Working Group Members. Accuracy of a Rapid Diagnostic Test for the Presence of Direct Oral Factor Xa or Thrombin Inhibitors in Urine-A Multicenter Trial. Thromb Haemost. 2020 Jan;120(1):132-140. doi: 10.1055/s-0039-1700545. Epub 2019 Nov 8.

  PMID: 31705521 BACKGROUND

• Kim PY, Di Giuseppantonio LR, Wu C, Douketis JD, Gross PL. An assay to measure levels of factor Xa inhibitors in blood and plasma. J Thromb Haemost. 2019 Jul;17(7):1153-1159. doi: 10.1111/jth.14451. Epub 2019 May 10.

  PMID: 30985986 BACKGROUND

• Mitrovic D, van Elp M, Veeger N, Lameijer H, Meijer K, van Roon E. Protocols for perioperative management of direct oral anticoagulants in hospitals: opportunities for improvement. Curr Med Res Opin. 2023 Jan;39(1):13-18. doi: 10.1080/03007995.2022.2141962. Epub 2022 Nov 12.

  PMID: 36305802 BACKGROUND

• Flaker GC, Theriot P, Binder LG, Dobesh PP, Cuker A, Doherty JU. Management of Periprocedural Anticoagulation: A Survey of Contemporary Practice. J Am Coll Cardiol. 2016 Jul 12;68(2):217-26. doi: 10.1016/j.jacc.2016.04.042.

  PMID: 27386777 BACKGROUND

• Kurlander JE, Barnes GD, Anderson MA, Haymart B, Kline-Rogers E, Kaatz S, Saini SD, Krein SL, Richardson CR, Froehlich JB. Mind the gap: results of a multispecialty survey on coordination of care for peri-procedural anticoagulation. J Thromb Thrombolysis. 2018 Apr;45(3):403-409. doi: 10.1007/s11239-018-1625-2.

  PMID: 29423559 BACKGROUND

• Wamala H, Scott IA, Caney X. Perioperative management of new oral anticoagulants in patients undergoing elective surgery at a tertiary hospital. Intern Med J. 2017 Dec;47(12):1412-1421. doi: 10.1111/imj.13513.

  PMID: 28589690 BACKGROUND

• Korenke M, Samba S, Stam B, Leis A, Kheterpal S, Colquhoun DA. The perioperative management of direct oral anticoagulants, a single center observational study. J Clin Anesth. 2020 Mar;60:92-93. doi: 10.1016/j.jclinane.2019.08.035. Epub 2019 Sep 11. No abstract available.

  PMID: 31520860 BACKGROUND

• Nascimento T, Birnie DH, Healey JS, Verma A, Joza J, Bernier ML, Essebag V. Managing novel oral anticoagulants in patients with atrial fibrillation undergoing device surgery: Canadian survey. Can J Cardiol. 2014 Feb;30(2):231-6. doi: 10.1016/j.cjca.2013.11.027. Epub 2013 Dec 4.

  PMID: 24461924 BACKGROUND

• Skeith L, Lazo-Langner A, Kovacs MJ. The equipoise of perioperative anticoagulation management: a Canadian cross-sectional survey. J Thromb Thrombolysis. 2014 May;37(4):411-3. doi: 10.1007/s11239-013-0960-6. No abstract available.

  PMID: 23868474 BACKGROUND

• Faraoni D, Samama CM, Ranucci M, Dietrich W, Levy JH. Perioperative management of patients receiving new oral anticoagulants: an international survey. Clin Lab Med. 2014 Sep;34(3):637-54. doi: 10.1016/j.cll.2014.06.006. Epub 2014 Jul 23.

  PMID: 25168948 BACKGROUND

• Chiang YZ, Al-Niaimi F, Craythorne E, Mallipeddi R. Perioperative management of novel oral anticoagulants in skin surgery: a national survey. Br J Dermatol. 2016 Sep;175(3):615-8. doi: 10.1111/bjd.14462. Epub 2016 Jun 2. No abstract available.

  PMID: 26854272 BACKGROUND

• Douketis JD, Spyropoulos AC, Anderson JM, Arnold DM, Bates SM, Blostein M, Carrier M, Caprini JA, Clark NP, Coppens M, Dentali F, Duncan J, Gross PL, Kassis J, Kowalski S, Lee AY, Le Gal G, Le Templier G, Li N, MacKay E, Shah V, Shivakumar S, Solymoss S, Spencer FA, Syed S, Tafur AJ, Vanassche T, Thiele T, Wu C, Yeo E, Schulman S. The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study for Patients on a Direct Oral Anticoagulant Who Need an Elective Surgery or Procedure: Design and Rationale. Thromb Haemost. 2017 Dec;117(12):2415-2424. doi: 10.1160/TH17-08-0553. Epub 2017 Dec 6.

  PMID: 29212129 BACKGROUND

• Merrelaar AE, Bogl MS, Buchtele N, Merrelaar M, Herkner H, Schoergenhofer C, Harenberg J, Douxfils J, Siriez R, Jilma B, Spiel AO, Schwameis M. Performance of a Qualitative Point-of-Care Strip Test to Detect DOAC Exposure at the Emergency Department: A Cohort-Type Cross-Sectional Diagnostic Accuracy Study. Thromb Haemost. 2022 Oct;122(10):1723-1731. doi: 10.1055/s-0042-1750327. Epub 2022 Jul 4.

  PMID: 35785816 BACKGROUND

• Lessire S, Douxfils J, Dincq AS, Mullier F. Periprocedural Management of Direct Oral Anticoagulants Should Be Guided by Accurate Laboratory Tests. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):787-788. doi: 10.1097/AAP.0000000000000448. No abstract available.

  PMID: 27662062 BACKGROUND

• Douxfils J, Adcock DM, Bates SM, Favaloro EJ, Gouin-Thibault I, Guillermo C, Kawai Y, Lindhoff-Last E, Kitchen S, Gosselin RC. 2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thromb Haemost. 2021 Aug;121(8):1008-1020. doi: 10.1055/a-1450-8178. Epub 2021 May 30.

  PMID: 33742436 BACKGROUND

• Cuker A, Burnett A, Triller D, Crowther M, Ansell J, Van Cott EM, Wirth D, Kaatz S. Reversal of direct oral anticoagulants: Guidance from the Anticoagulation Forum. Am J Hematol. 2019 Jun;94(6):697-709. doi: 10.1002/ajh.25475. Epub 2019 Apr 16.

  PMID: 30916798 BACKGROUND

• Spyropoulos AC, Giannis D, Cohen J, John S, Myrka A, Inlall D, Qiu M, Akgul S, Hyman RJ, Wang JJ. Implementation of the Management of Anticoagulation in the Periprocedural Period App Into an Electronic Health Record: A Prospective Cohort Study. Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620925910. doi: 10.1177/1076029620925910.

  PMID: 32633538 BACKGROUND

• Lee J, Kong X, Haymart B, Kline-Rogers E, Kaatz S, Shah V, Ali MA, Kozlowski J, Froehlich J, Barnes GD. Outcomes in patients undergoing periprocedural interruption of warfarin or direct oral anticoagulants. J Thromb Haemost. 2022 Nov;20(11):2571-2578. doi: 10.1111/jth.15850. Epub 2022 Sep 1.

  PMID: 35962753 BACKGROUND

• Douketis JD, Spyropoulos AC, Duncan J, Carrier M, Le Gal G, Tafur AJ, Vanassche T, Verhamme P, Shivakumar S, Gross PL, Lee AYY, Yeo E, Solymoss S, Kassis J, Le Templier G, Kowalski S, Blostein M, Shah V, MacKay E, Wu C, Clark NP, Bates SM, Spencer FA, Arnaoutoglou E, Coppens M, Arnold DM, Caprini JA, Li N, Moffat KA, Syed S, Schulman S. Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant. JAMA Intern Med. 2019 Nov 1;179(11):1469-1478. doi: 10.1001/jamainternmed.2019.2431.

  PMID: 31380891 BACKGROUND

• Steinberg BA, Hellkamp AS, Lokhnygina Y, Halperin JL, Breithardt G, Passman R, Hankey GJ, Patel MR, Becker RC, Singer DE, Hacke W, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Piccini JP; ROCKET AF Steering Committee and Investigators. Use and outcomes of antiarrhythmic therapy in patients with atrial fibrillation receiving oral anticoagulation: results from the ROCKET AF trial. Heart Rhythm. 2014 Jun;11(6):925-32. doi: 10.1016/j.hrthm.2014.03.006. Epub 2014 May 13.

  PMID: 24833235 BACKGROUND

• Valentine D GM, Grissinger M. . Valentine D, Gaunt MJ, Grissinger M. Identifying Patient Harm from Direct Oral Anticoagulants. Available from http://patientsafety.pa.gov/ADVISORIES/Pages/201806_DOACs.aspx. 2020

  BACKGROUND

• Broderick JP, Bonomo JB, Kissela BM, Khoury JC, Moomaw CJ, Alwell K, Woo D, Flaherty ML, Khatri P, Adeoye O, Ferioli S, Kleindorfer DO. Withdrawal of antithrombotic agents and its impact on ischemic stroke occurrence. Stroke. 2011 Sep;42(9):2509-14. doi: 10.1161/STROKEAHA.110.611905. Epub 2011 Jun 30.

  PMID: 21719769 BACKGROUND

• Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.

  PMID: 26095867 BACKGROUND

• Spyropoulos AC, Al-Badri A, Sherwood MW, Douketis JD. Periprocedural management of patients receiving a vitamin K antagonist or a direct oral anticoagulant requiring an elective procedure or surgery. J Thromb Haemost. 2016 May;14(5):875-85. doi: 10.1111/jth.13305. Epub 2016 Apr 7.

  PMID: 26988871 BACKGROUND

• Douketis JD, Syed S, Li N, Narouze S, Radwi M, Duncan J, Schulman S, Spyropoulos AC. A physician survey of perioperative neuraxial anesthesia management in patients on a direct oral anticoagulant. Res Pract Thromb Haemost. 2020 Dec 16;5(1):159-167. doi: 10.1002/rth2.12430. eCollection 2021 Jan.

  PMID: 33537540 BACKGROUND

• Albaladejo P, Bonhomme F, Blais N, Collet JP, Faraoni D, Fontana P, Godier A, Llau J, Longrois D, Marret E, Mismetti P, Rosencher N, Roullet S, Samama CM, Schved JF, Sie P, Steib A, Susen S; French Working Group on Perioperative Hemostasis (GIHP). Management of direct oral anticoagulants in patients undergoing elective surgeries and invasive procedures: Updated guidelines from the French Working Group on Perioperative Hemostasis (GIHP) - September 2015. Anaesth Crit Care Pain Med. 2017 Feb;36(1):73-76. doi: 10.1016/j.accpm.2016.09.002. Epub 2016 Sep 20.

  PMID: 27659969 BACKGROUND

• Raval AN, Cigarroa JE, Chung MK, Diaz-Sandoval LJ, Diercks D, Piccini JP, Jung HS, Washam JB, Welch BG, Zazulia AR, Collins SP; American Heart Association Clinical Pharmacology Subcommittee of the Acute Cardiac Care and General Cardiology Committee of the Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Quality of Care and Outcomes Research. Management of Patients on Non-Vitamin K Antagonist Oral Anticoagulants in the Acute Care and Periprocedural Setting: A Scientific Statement From the American Heart Association. Circulation. 2017 Mar 7;135(10):e604-e633. doi: 10.1161/CIR.0000000000000477. Epub 2017 Feb 6.

  PMID: 28167634 BACKGROUND

• Doherty JU, Gluckman TJ, Hucker WJ, Januzzi JL Jr, Ortel TL, Saxonhouse SJ, Spinler SA. 2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With Nonvalvular Atrial Fibrillation: A Report of the American College of Cardiology Clinical Expert Consensus Document Task Force. J Am Coll Cardiol. 2017 Feb 21;69(7):871-898. doi: 10.1016/j.jacc.2016.11.024. Epub 2017 Jan 9.

  PMID: 28081965 BACKGROUND

• Duffett L. Deep Venous Thrombosis. Ann Intern Med. 2022 Sep;175(9):ITC129-ITC144. doi: 10.7326/AITC202209200. Epub 2022 Sep 13.

  PMID: 36095313 BACKGROUND

• Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6.

  PMID: 26780736 BACKGROUND

• Barnes GD, Lucas E, Alexander GC, Goldberger ZD. National Trends in Ambulatory Oral Anticoagulant Use. Am J Med. 2015 Dec;128(12):1300-5.e2. doi: 10.1016/j.amjmed.2015.05.044. Epub 2015 Jul 2.

  PMID: 26144101 BACKGROUND

• Weitz JI, Semchuk W, Turpie AG, Fisher WD, Kong C, Ciaccia A, Cairns JA. Trends in Prescribing Oral Anticoagulants in Canada, 2008-2014. Clin Ther. 2015 Nov 1;37(11):2506-2514.e4. doi: 10.1016/j.clinthera.2015.09.008. Epub 2015 Oct 16.

  PMID: 26481493 BACKGROUND

• Gao L, Tadrous M, Knowles S, Mamdani M, Paterson JM, Juurlink D, Gomes T. Prior Authorization and Canadian Public Utilization of Direct-Acting Oral Anticoagulants. Healthc Policy. 2017 Nov;13(2):68-78. doi: 10.12927/hcpol.2017.25321.

  PMID: 29274228 BACKGROUND

• Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, Themeles E, Heidbuchel H, Avezum A, Reilly P, Connolly SJ, Yusuf S, Ezekowitz M; RE-LY Investigators. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation. 2012 Jul 17;126(3):343-8. doi: 10.1161/CIRCULATIONAHA.111.090464. Epub 2012 Jun 14.

  PMID: 22700854 BACKGROUND

• Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, Dunn AS, Kunz R. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e326S-e350S. doi: 10.1378/chest.11-2298.

  PMID: 22315266 BACKGROUND

• Proietti M, Laroche C, Opolski G, Maggioni AP, Boriani G, Lip GYH; AF Gen Pilot Investigators. 'Real-world' atrial fibrillation management in Europe: observations from the 2-year follow-up of the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase. Europace. 2017 May 1;19(5):722-733. doi: 10.1093/europace/euw112.

  PMID: 27194538 BACKGROUND

• Steinberg BA, Gao H, Shrader P, Pieper K, Thomas L, Camm AJ, Ezekowitz MD, Fonarow GC, Gersh BJ, Goldhaber S, Haas S, Hacke W, Kowey PR, Ansell J, Mahaffey KW, Naccarelli G, Reiffel JA, Turpie A, Verheugt F, Piccini JP, Kakkar A, Peterson ED, Fox KAA; GARFIELD-AF; ORBIT-AF Investigators. International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J. 2017 Dec;194:132-140. doi: 10.1016/j.ahj.2017.08.011. Epub 2017 Aug 24.

  PMID: 29223431 BACKGROUND

• Williams BA, Honushefsky AM, Berger PB. Temporal Trends in the Incidence, Prevalence, and Survival of Patients With Atrial Fibrillation From 2004 to 2016. Am J Cardiol. 2017 Dec 1;120(11):1961-1965. doi: 10.1016/j.amjcard.2017.08.014. Epub 2017 Aug 30.

  PMID: 29033050 BACKGROUND

• Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.

  PMID: 23831166 BACKGROUND

• Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K; ESC Scientific Document Group. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022 Oct 14;43(39):3826-3924. doi: 10.1093/eurheartj/ehac270. No abstract available.

  PMID: 36017553 BACKGROUND

• Parks AL, Fang MC. Periprocedural Anticoagulation. Ann Intern Med. 2023 Apr;176(4):ITC49-ITC64. doi: 10.7326/AITC202304180. Epub 2023 Apr 11.

  PMID: 37037035 BACKGROUND

• Narouze S, Benzon HT, Provenzano DA, Buvanendran A, De Andres J, Deer TR, Rauck R, Huntoon MA. Interventional spine and pain procedures in patients on antiplatelet and anticoagulant medications: guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain. Reg Anesth Pain Med. 2015 May-Jun;40(3):182-212. doi: 10.1097/AAP.0000000000000223.

  PMID: 25899949 BACKGROUND

• Narouze S, Benzon HT, Provenzano D, Buvanendran A, De Andres J, Deer T, Rauck R, Huntoon MA. Interventional Spine and Pain Procedures in Patients on Antiplatelet and Anticoagulant Medications (Second Edition): Guidelines From the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain. Reg Anesth Pain Med. 2018 Apr;43(3):225-262. doi: 10.1097/AAP.0000000000000700.

  PMID: 29278603 BACKGROUND

• Douketis JD, Spyropoulos AC, Murad MH, Arcelus JI, Dager WE, Dunn AS, Fargo RA, Levy JH, Samama CM, Shah SH, Sherwood MW, Tafur AJ, Tang LV, Moores LK. Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline. Chest. 2022 Nov;162(5):e207-e243. doi: 10.1016/j.chest.2022.07.025. Epub 2022 Aug 11.

  PMID: 35964704 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Douketis, MD

  McMaster University/St. Joseph's Healthcare

  PRINCIPAL INVESTIGATOR

• Joseph Shaw, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Douketis, MD

CONTACT

905-522-1155; jdouket@mcmaster.ca

Melanie St John

CONTACT

stjohm1@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. James Douketis-Principal Investigator

Model Details: Patients taking Apixaban, Dabigatran, Rivaroxaban or Edoxaban will be randomly assigned to follow 1) PAUSE or 2) ASRA perioperative DOAC management.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6); US (6); GR (1); BE (1)