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NCT06957366 · ClinicalTrials.gov registry record · NA
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
A NA study of Atrial Fibrillation (AF) and VTE, sponsored by McMaster University.
- Recruiting
- Registry status
- NA
- Development phase
- 920
- Enrollment target
- 14
- Study locations
NCT06957366 is a NA study of Atrial Fibrillation (AF) and VTE that is actively recruiting participants, run by McMaster University. The registered enrollment target is 920 participants, above the 665-participant average among 17 other Atrial Fibrillation (AF) trials with a reported enrollment target (38% higher). The trial reports 14 study locations across 10 states.
The verdict
NCT06957366, a NA study of Atrial Fibrillation (AF) and VTE, is actively recruiting participants, sponsored by McMaster University.
- RECRUITING
- Registry status
- NA
- Development phase
- 920 participants
- Enrollment target
- 14
- Study locations
Study 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 Studied
Interventions
- OTHER PAUSE Perioperative DOAC Management
- OTHER ASRA Perioperative DOAC Management
Study Locations (14)
Ontario
- St. Joesph's Healthcare - Hamilton
- Juravinski - Hamilton
- The Ottawa Hospital - Ottawa
- L'Hospital Montfort - Ottawa
- Toronto General Hospital - Toronto
Connecticut
- Hartford Health Care - Hartford
Illinois
- North Shore University Health - Evanston
Massachusetts
- Brigham and Woman's Hospital - Boston
Michigan
- Henry Ford Health Care - Detroit
New York
- Northwell Health System - New York
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Belgium
- University of Leuven - Leuven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 920 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06957366
The ClinicalTrials.gov registry entry for NCT06957366 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 920 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 665-participant average among 17 other Atrial Fibrillation (AF) trials with a reported enrollment target (38% higher). The listed sponsor is McMaster University, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Atrial Fibrillation (AF) appearing as the primary indexed condition, and to 2 interventions - of which PAUSE Perioperative DOAC Management is the first listed.
NCT06957366 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Ontario, Connecticut, Illinois.
Frequently Asked Questions
What is clinical trial NCT06957366 about?
NCT06957366 is a clinical study titled "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". 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...
What is the current status of trial NCT06957366?
This trial is currently recruiting. It is a NA study. The enrollment target is 920 participants. The study started on 2025-04-01. Estimated completion is 2027-12-31.
What conditions does trial NCT06957366 study?
This clinical trial studies the following conditions: Atrial Fibrillation (AF), VTE.
What interventions are being tested in trial NCT06957366?
The interventions under investigation include: PAUSE Perioperative DOAC Management (OTHER), ASRA Perioperative DOAC Management (OTHER).
Who is sponsoring clinical trial NCT06957366?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06957366 being conducted?
This trial has 14 study locations across Connecticut, Illinois, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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