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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Heart and Stroke Foundation of Canada | OTHER |
| Bayer | INDUSTRY |
| Bristol-Myers Squibb |
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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.
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:
Interrupted Dabigatran
Interrupted Rivaroxaban
Interrupted Apixaban
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continued NOAC | Experimental | - Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout |
|
| Interrupted NOAC | Active Comparator | Interrupted Dabigatran:
Interrupted Rivaroxaban:
Interrupted Apixaban:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | NOAC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant hematoma | Defined as:
| 2 weeks post-op or until resolution of hematoma |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major peri-operative bleeding events and thrombo-embolic events |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Birnie, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Vidal Essebag, MD | McGill University | Principal Investigator |
| Jeff Healey, MD | McMaster University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| University of Alberta-ECAT Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30462279 | Result | Birnie DH, Healey JS, Wells GA, Ayala-Paredes F, Coutu B, Sumner GL, Becker G, Verma A, Philippon F, Kalfon E, Eikelboom J, Sandhu RK, Nery PB, Lellouche N, Connolly SJ, Sapp J, Essebag V. Continued vs. interrupted direct oral anticoagulants at the time of device surgery, in patients with moderate to high risk of arterial thrombo-embolic events (BRUISE CONTROL-2). Eur Heart J. 2018 Nov 21;39(44):3973-3979. doi: 10.1093/eurheartj/ehy413. | |
| 31610718 |
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| INDUSTRY |
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| Rivaroxaban | Drug | NOAC |
|
|
| Apixaban | Drug | NOAC |
|
|
| 2 weeks post-op |
| Edmonton |
| Alberta |
| T5H 3V9 |
| Canada |
| Victoria Cardiac Arrhythmia Trials Inc. | Victoria | British Columbia | V8T 1Z4 | Canada |
| Hamilton Health Sciences General Campus | Hamilton | Ontario | L8L 2X2 | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Rouge Valley Health System-Centenary Campus | Toronto | Ontario | M1E 4B9 | Canada |
| Humber River Hospital | Toronto | Ontario | M3M 0B2 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM), Hotel Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| McGill University Health Centre/Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| Hopital Sacre-Coeur | Montreal | Quebec | H4J 1C5 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke-Hopital Fleurimont | Sherbrooke | Quebec | JiH 5N4 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Québec | G1V 4G5 | Canada |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Derived |
| Essebag V, Healey JS, Joza J, Nery PB, Kalfon E, Leiria TLL, Verma A, Ayala-Paredes F, Coutu B, Sumner GL, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Toal S, Sturmer M, Kavanagh K, Crystal E, Wells GA, Krahn AD, Birnie DH. Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2. Circ Arrhythm Electrophysiol. 2019 Oct;12(10):e007545. doi: 10.1161/CIRCEP.119.007545. Epub 2019 Oct 15. |
| ID | Term |
|---|---|
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
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