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The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial (DANCE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04284839
Recruitment Status : Not yet recruiting
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Richard Whitlock, McMaster University

Brief Summary:
The DANCE Trial is a multi-centre, randomized controlled trial comparing the safety of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) in the early period (30 days) after cardiac surgery in patients with an indication for oral anticoagulation.

Condition or disease Intervention/treatment Phase
Bleeding Post Cardiac Surgery Indication for Anticoagulation Drug: DOAC Drug: VKA Phase 3

Detailed Description:

About 10% of patients undergoing cardiac surgery have a prior history of atrial fibrillation (AF). Additionally, in the early post-operative period after cardiac surgery, 30-60% of patients develop AF which is associated with a significantly higher risk of stroke, even when transient. Oral anticoagulation (OAC) therapy is the preferred method of thromboembolic prevention in these patients. In the post-operative period, however, the balance of benefits and risks of OAC may differ and the most safe and effective OAC therapy in that patient population is uncertain.

Until 2009, vitamin K antagonists were the only OAC agents available for patients with AF. Although effective, their use is limited by a narrow therapeutic index requiring frequent international normalized ratio (INR) measurements to ensure appropriate levels of anticoagulation. This key limitation leads to non-compliance and discontinuation. In the last decade, direct oral anticoagulants (DOACs) - inhibitors of factor Xa or thrombin- have become broadly used in patients with atrial fibrillation. Treatment with a DOAC in patients with AF has been demonstrated to yield similar rates of thromboembolism, and a lower risk of intracranial bleeding when compared to vitamin K antagonists during long-term follow-up. Moreover, DOACs are more convenient for both patients and clinicians. They have a rapid onset of effect, fixed dosage that obviates the need for regular monitoring, and few interactions with food and other medications

The purpose of this study is to establish whether DOACs are as safe as VKAs in the first few weeks after heart surgery. The results of this study will impact the treatment of hundreds of thousands of patients in the world every year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5900 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Direct Oral Anticoagulation (DOAC)
Patients in the intervention group will receive a DOAC at doses recommended for the indication, adjusted for their renal function is required. The choice of DOAC will be at the discretion of the treating physician.
Drug: DOAC
Patients will receive a DOAC at doses recommended for the indication, adjusted for their renal function is required. The choice of DOAC will be at the discretion of the treating physician.
Other Names:
  • Apixaban
  • Dabigatran
  • Edoxaban
  • Rivaroxaban

Placebo Comparator: Vitamin K Antagonist
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Drug: VKA
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Other Name: Warfarin




Primary Outcome Measures :
  1. Major Bleeding [ Time Frame: 3-months post-op ]
    Major bleeding over follow-up defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more or that which requires the transfusion of ≥2 units of packed red blood cells (as defined by the International Society of Thrombosis and Hemostasis)


Secondary Outcome Measures :
  1. Pleural or pericardial effusion requiring drainage [ Time Frame: 3-months post-op ]
    Pleural effusion requiring drainage with either: needle, seldinger-technique percutaneous chest tube, surgical chest tube Pericardial effusion requiring drainage with either: needle, seldinger-technique percutaneous pericardial drain, pericardial window

  2. Systemic thromboembolism [ Time Frame: 3-months post-op ]
    Abrupt vascular insufficiency associated with evidence of arterial occlusion in the absence of other likely mechanisms

  3. Ischemic stroke [ Time Frame: 3-months post-op ]
    Focal brain infarction caused by an arterial (or rarely venous) obstruction and as documented by CT/MRI that is normal or shows an infarct in the clinically expected area.

  4. Deep vein thrombosis [ Time Frame: 3-months post-op ]

    Criteria for the objective confirmation of deep vein thrombosis (DVT) include:

    i) A persistent filling defect on contrast venography in the deep venous system ii) Non-compressibility of one or more venous segments in the deep venous system on compression ultrasonography and/or thrombus visualized with Doppler.

    iii) A clearly defined intraluminal filling defect on contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) in the deep venous system


  5. Pulmonary Embolism [ Time Frame: 3-months post-op ]

    Criteria for the objective diagnosis of pulmonary embolism include:

    i) A high probability ventilation/perfusion lung scan ii) An intraluminal filling defect of segmental or larger artery on helical CT scan iii) An intraluminal filling defect on pulmonary angiography iv) A positive diagnostic test for DVT (e.g., positive compression ultrasound) and one of the following: • non-diagnostic (i.e., low or intermediate probability) ventilation/perfusion lung scan • non-diagnostic (i.e., subsegmental defects or technically inadequate study) helical CT scan v) evidence of pulmonary embolism in a segmental or larger artery on autopsy


  6. Length of post-operative stay [ Time Frame: 3-months post-op ]
    Number of nights alive and in hospital after surgery



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Age ≥18 years at the time of enrolment,
  2. Open heart surgery in the last 7 days,
  3. Any indication for anticoagulation (e.g. atrial fibrillation [AF] [including pre-existing AF or post-operative AF], atrial flutter, venous thromboembolism, new bioprosthetic valve replacement, mitral valve repair),
  4. Written informed consent from either the patient or a substitute decision-maker.

Exclusion Criteria:

  1. Mechanical valve replacement,
  2. Antiphospholipid syndrome (triple positive),
  3. Severe renal failure (Cockcroft-Gault equation; creatinine clearance <30 ml/min),
  4. Known significant liver disease (Child-Pugh classification B and C),
  5. Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis,
  6. Known contraindication for any DOAC or VKA,
  7. Women who are pregnant, breastfeeding, or of childbearing potential,
  8. Previously enrolled in this trial,
  9. Follow-up not possible.

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): NCT04284839


Contacts
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Contact: Emilie Belley-Cote, MD, MSc 905-527-4322 ext 40306 emilie.belley-cote@phri.ca
Contact: Richard Whitlock, MD, PhD 905-527-4322 ext 40306 richard.whitlock@phri.ca

Locations
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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Contact: Emilie Belley-Cote, MD, MSc    905-527-4322 ext 40306    emilie.belley-cote@phri.ca   
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Emilie Belley-Cote, MD, MSc McMaster University

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Responsible Party: Richard Whitlock, Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT04284839    
Other Study ID Numbers: DANCE-2020
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will establish a plan for the full-scale study but there is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Richard Whitlock, McMaster University:
Direct Oral Anticoagulant
Vitamin K Antagonist
Bleeding
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Vitamin K
Warfarin
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs