Clinical Trial: Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arter

Brief Summary: The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.

Detailed Summary:

This is a prospective, open-label, randomized trial, with 1:1 randomization to either continued NOAC or interrupted NOAC in patients with non-rheumatic atrial fibrillation or atrial flutter and at moderate to high risk of arterial thrombo-embolic events who require device surgery.

All patients in the study will be receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment. The peri-operative management of the NOAC the patient is receiving is randomized to Interrupted NOAC or Continued NOAC.

Interrupted NOAC arm:

  1. Interrupted Dabigatran

    • based on renal function, patients will discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min, and 2 days before surgery if GFR is 30-50 mL/min.
    • Dabigatran will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

  2. Interrupted Rivaroxaban

    • patients will discontinue Rivaroxaban 1 full day before surgery.
    • Rivaroxaban will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

  3. Interrupted Apixaban

    • patients will discontinue Apixaban 1 full day before surgery.
    • Apixaban will be resumed at the next regular dose time, > or = 24 hours after
      Sponsor: Ottawa Heart Institute Research Corporation

      Current Primary Outcome: Clinically significant hematoma [ Time Frame: 2 weeks post-op or until resolution of hematoma ]

      Defined as:

      1. Hematoma requiring re-operation

        - Defined as a hematoma that continues to expand despite all appropriate non-operative measures, or is producing impending or actual wound breakdown or skin necrosis. Minor hematomas that are evacuated at the time of other re-operation (eg. for lead repositioning) are not considered as a primary outcome.

        or

      2. Hematoma resulting in prolongation of hospitalization

        - Defined as extended hospitalization or rehospitalization for > 24 hours, post index surgery, primarily due to hematoma.

        or

      3. Hematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation for > or = 24 hours, in response to wound hematoma.


      Original Primary Outcome: Clinically significant hematoma [ Time Frame: 2 weeks post-op or until resolution of hematoma ]

      Defined as:

      1. Hematoma requiring re-operation or
      2. Hematoma resulting in prolongation of hospitalization or
      3. Hematoma requiring interruption of anti-coagulation


      Current Secondary Outcome: Composite of major peri-operative bleeding events and thrombo-embolic events [ Time Frame: 2 weeks post-op ]

      1. Each of the components of the primary outcome

      2. Composite of all other major peri-operative bleeding events defined as:

        • hemothorax
        • cardiac tamponade
        • significant pericardial effusion

      3. Thrombo-embolic events defined as:

        • transient ischemic attack
        • stroke
        • deep venous thrombosis
        • pulmonary embolism
        • peripheral embolus to limb
        • peripheral embolus to other major organ
      4. All cause mortality
      5. Cost utilization
      6. Patient quality of life and peri-operative pain, and satisfaction


      Original Secondary Outcome: Same as current

      Information By: Ottawa Heart Institute Research Corporation

      Dates:
      Date Received: August 27, 2012
      Date Started: January 2013
      Date Completion: December 2018
      Last Updated: April 21, 2017
      Last Verified: April 2017