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Study identifier: NCT06957366 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Atrial Fibrillation (AF) · VTE  ·  Sponsor: McMaster University

PhaseNA
Planned participants920
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

James Douketis, MD  ·  905-522-1155  ·  jdouket@mcmaster.ca

Melanie St John  ·  stjohm1@mcmaster.ca

Always discuss trial participation with your own doctor first.

Locations (14)

Hartford Health CareHartford, Connecticut, United StatesNot Yet Recruiting
North Shore University HealthEvanston, Illinois, United StatesNot Yet Recruiting
Brigham and Woman's HospitalBoston, Massachusetts, United StatesNot Yet Recruiting
Henry Ford Health CareDetroit, Michigan, United StatesNot Yet Recruiting
Northwell Health SystemNew York, New York, United StatesNot Yet Recruiting
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania, United StatesNot Yet Recruiting
University of LeuvenLeuven, Belgium, BelgiumNot Yet Recruiting
Winnipeg Health Sciences CenterWinnipeg, Manitoba, CanadaNot Yet Recruiting
St. Joesph's HealthcareHamilton, Ontario, CanadaRecruiting
JuravinskiHamilton, Ontario, CanadaNot Yet Recruiting
The Ottawa HospitalOttawa, Ontario, CanadaNot Yet Recruiting
L'Hospital MontfortOttawa, Ontario, CanadaNot Yet Recruiting

+ 2 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06957366