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)
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| ClinicalTrials.gov Identifier: NCT01675076 |
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Recruitment Status :
Completed
First Posted : August 29, 2012
Last Update Posted : October 7, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hematoma | Drug: Dabigatran Drug: Rivaroxaban Drug: Apixaban | Phase 3 |
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:
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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.
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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.
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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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 663 participants |
| 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 |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | October 2017 |
| Actual Study Completion Date : | May 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Continued NOAC
- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout
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Drug: Dabigatran
NOAC
Other Name: Pradaxa Drug: Rivaroxaban NOAC
Other Name: Xarelto Drug: Apixaban NOAC
Other Name: Eliquis |
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Active Comparator: Interrupted NOAC
Interrupted Dabigatran:
Interrupted Rivaroxaban:
Interrupted Apixaban:
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Drug: Dabigatran
NOAC
Other Name: Pradaxa Drug: Rivaroxaban NOAC
Other Name: Xarelto Drug: Apixaban NOAC
Other Name: Eliquis |
- Clinically significant hematoma [ Time Frame: 2 weeks post-op or until resolution of hematoma ]
Defined as:
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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
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Hematoma resulting in prolongation of hospitalization
- Defined as extended hospitalization or rehospitalization for > 24 hours, post index surgery, primarily due to hematoma.
or
- Hematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation for > or = 24 hours, in response to wound hematoma.
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- Composite of major peri-operative bleeding events and thrombo-embolic events [ Time Frame: 2 weeks post-op ]
- Each of the components of the primary outcome
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Composite of all other major peri-operative bleeding events defined as:
- hemothorax
- cardiac tamponade
- significant pericardial effusion
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Thrombo-embolic events defined as:
- transient ischemic attack
- stroke
- deep venous thrombosis
- pulmonary embolism
- peripheral embolus to limb
- peripheral embolus to other major organ
- All cause mortality
- Cost utilization
- Patient quality of life and peri-operative pain, and satisfaction
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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 | |
| Principal Investigator: | David Birnie, MD | Ottawa Heart Institute Research Corporation | |
| Principal Investigator: | Vidal Essebag, MD | McGill University | |
| Study Chair: | Jeff Healey, MD | McMaster University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ottawa Heart Institute Research Corporation |
| ClinicalTrials.gov Identifier: | NCT01675076 |
| Other Study ID Numbers: |
UOHI-05 |
| First Posted: | August 29, 2012 Key Record Dates |
| Last Update Posted: | October 7, 2019 |
| Last Verified: | October 2019 |
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Hematoma novel oral anti-coagulant (NOAC) Device surgery |
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Hematoma Hemorrhage Pathologic Processes Rivaroxaban Apixaban Dabigatran Factor Xa Inhibitors |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |