Recruiting

DOACs

Sponsor:

McMaster University

Code:

NCT06957366

Conditions

Atrial Fibrillation (AF)

VTE

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PAUSE Perioperative DOAC Management

ASRA Perioperative DOAC Management

Study Details

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.

Conditions

Atrial Fibrillation (AF)

VTE

Study ID

NCT06957366

Start date

Apr 1, 2025

Status verified date

May, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

920 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Apixaban

Patients currently taking Apixaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

active comparator: Dabigatran

Patients currently taking Dabigatran that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

active comparator: Rivaroxaban

Patients currently taking Rivaroxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

active comparator: Edoxaban

Patients currently taking Edoxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.

Interventions

PAUSE Perioperative DOAC Management

PAUSE management is simple and easy to apply as patients having a high-bleed-risk surgery/neuraxial procedure interrupt DOACs for 2 days before and 2 days after surgery without heparin bridging or DOAC level testing.

ASRA Perioperative DOAC Management

ASRA management is more complex, requiring 72-120 hours DOAC interruption and, in selected patients, pre-operative heparin bridging and DOAC level testing.

Primary outcome measure

  • Proportion of patients randomized to each study arm with a residual pre-operative DOAC level < 30 ng/mL [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

James Douketis, MD

905-522-1155jdouket@mcmaster.ca

Melanie St John

stjohm1@mcmaster.ca

Locations

St. Joesph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Ralph Laurence Gaa

9055221155gaar@mcmaster.ca

Principal Investigator:

James Douketis, MD

More Information

Sponsor

McMaster University

Last update posted

May 9, 2025

Last verified

May, 2025

Keywords

  • anticoagulation
  • atrial Fibrillation
  • Surgery
  • Oral Anticoagulant
  • Blood thinner
  • DOAC
  • VTE
  • Interruption
  • PAUSE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McMaster University on 2025-05-09.