Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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

NCT06957366 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 920 participants
Start Date 2025-04-01
Est. Completion 2027-12-31
Phase NA

Sponsor

McMaster University

13 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 920 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McMaster University, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06957366 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Ontario, Connecticut, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06957366?

The interventions under investigation include: PAUSE Perioperative DOAC Management (OTHER), ASRA Perioperative DOAC Management (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06957366?

This trial is sponsored by McMaster University, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial