Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Atrial Fibrillation (AF) and VTE, sponsored by McMaster University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT06957366 shows while recruiting
NCT06957366 is an interventional study that assigns participants to a tested intervention. The registered 920 participants enrollment target is mid-sized for trials with a published cap, above the 665-participant average among 17 other Atrial Fibrillation (AF) trials with a reported enrollment target (38% higher).
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 lists 14 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation (AF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06957366's enrollment target sits among peer trials
920 7th of 17 higher than 11 of 17 other Atrial Fibrillation (AF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation (AF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity
RECRUITING · NA
-
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
RECRUITING · NA
-
Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
RECRUITING · NA
-
Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation
RECRUITING · NA
-
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
RECRUITING · NA
-
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04589845 · 920 participants · Phase 2
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
- NCT06109870 · 920 participants · NA
Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
- NCT07174336 · 920 participants · Phase 3
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
- NCT07151001 · 922 participants
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI