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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 (BRUISECONTROL2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01675076
First Posted: August 29, 2012
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boehringer Ingelheim
Heart and Stroke Foundation of Canada
Bayer
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation
  Purpose
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.

Condition Intervention Phase
Hematoma Drug: Dabigatran Drug: Rivaroxaban Drug: Apixaban Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Arterial Thrombo-embolic Events, Leads to a Reduction in the Incidence of Clinically Significant Hematoma

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 663
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continued NOAC
- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout
Drug: Dabigatran
NOAC
Other Name: Pradaxa
Drug: Rivaroxaban
NOAC
Other Name: Xarelto
Drug: Apixaban
NOAC
Other Name: Eliquis
Active Comparator: Interrupted NOAC

Interrupted Dabigatran:

  • Discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min
  • Resume Dabigatran at next regular dose timing >or = 24 hours after the end of surgery

Interrupted Rivaroxaban:

  • Discontinue Rivaroxaban 1 full day before surgery
  • Resume Rivaroxaban at next regular dose timing >or = 24 hours after the end of surgery

Interrupted Apixaban:

  • Discontinue Apixaban 1 full day before surgery
  • Resume Apixaban at next regular dose timing >or = 24 hours after the end of surgery
Drug: Dabigatran
NOAC
Other Name: Pradaxa
Drug: Rivaroxaban
NOAC
Other Name: Xarelto
Drug: Apixaban
NOAC
Other Name: Eliquis

Detailed Description:

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 the end of surgery.

Continued NOAC arm:

-patients will continue their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout.

All patients will have a baseline clinical lab test of serum creatinine or GRF measured.

Patients will be seen post-op on the day of their surgery for assessment of the surgical site and each day throughout their hospital stay by a blinded member of the research team. A telephone follow-up will be done on day 3-4 post surgery by an unblinded team member. All patients are seen 1-2 weeks post-op at their first routine post-op device clinic visit, for surgical site assessment by the blinded assessor and to complete Quality of Life questionnaires. Patients will be seen for assessment in the case of any bleeding or development of pocket swelling or hematoma. Patients developing a hematoma will be followed until resolution of the hematoma.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision)
  • receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment
  • non-rheumatic atrial fibrillation and/or atrial flutter at moderate or high risk of ATE defined as: i) CHA2DS2VASc score greater than or equal to 2 OR ii) CHA2DS2VASc score < 2 with plan for cardioversion or defibrillation threshold testing at time of device surgery

Exclusion Criteria:

  • unable or unwilling to provide informed consent
  • history of noncompliance of medical therapy
  • active device infection
  • eGFR < 30 mL/min
  • contraindication to NOAC
  • rheumatic valvular disease with hemodynamically significant valve lesion
  • mechanical heart valve
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675076


Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
University of Alberta-ECAT Group
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, Canada, V8T 1Z4
Canada, Ontario
Hamilton Health Sciences General Campus
Hamilton, Ontario, Canada, L8L 2X2
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Rouge Valley Health System-Centenary Campus
Toronto, Ontario, Canada, M1E 4B9
Humber River Hospital
Toronto, Ontario, Canada, M3M 0B2
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Centre Hospitalier de l'Universite de Montreal (CHUM), Hotel Dieu
Montreal, Quebec, Canada, H2W 1T8
McGill University Health Centre/Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Hopital Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
Centre Hospitalier Universitaire de Sherbrooke-Hopital Fleurimont
Sherbrooke, Quebec, Canada, JiH 5N4
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec, Canada, G1V 4G5
Israel
Galilee Medical Center
Nahariya, Israel, 22100
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Boehringer Ingelheim
Heart and Stroke Foundation of Canada
Bayer
Bristol-Myers Squibb
Investigators
Principal Investigator: David Birnie, MD Ottawa Heart Institute Research Corporation
Principal Investigator: Vidal Essebag, MD McGill University
Study Chair: Jeff Healey, MD McMaster University
  More Information

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01675076     History of Changes
Other Study ID Numbers: UOHI-05
First Submitted: August 27, 2012
First Posted: August 29, 2012
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Ottawa Heart Institute Research Corporation:
Hematoma
novel oral anti-coagulant (NOAC)
Device surgery

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes
Rivaroxaban
Apixaban
Dabigatran
Anticoagulants
Coagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action