NCT06957366 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
| NCT ID | NCT06957366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 920 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 920 participants in total. It began in 2025-04-01 with a primary completion date of 2027-12-31.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
James Douketis, MD
PRINCIPAL INVESTIGATOR
McMaster University/St. Joseph's Healthcare
Frequently Asked Questions
Who can join the NCT06957366 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT06957366 currently recruiting?
Yes, NCT06957366 is actively recruiting participants. Contact the research team at jdouket@mcmaster.ca for enrollment information.
Where is the NCT06957366 trial being conducted?
This trial is being conducted at Hartford, United States, Evanston, United States, Boston, United States, Detroit, United States and 10 additional locations.
Who is sponsoring the NCT06957366 clinical trial?
NCT06957366 is sponsored by McMaster University. The principal investigator is James Douketis, MD at McMaster University/St. Joseph's Healthcare. The trial plans to enroll 920 participants.
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