Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE February 24, 2020
First Posted Date  ICMJE February 26, 2020
Last Update Posted Date February 26, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • 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
  • Systemic thromboembolism [ Time Frame: 3-months post-op ]
    Abrupt vascular insufficiency associated with evidence of arterial occlusion in the absence of other likely mechanisms
  • 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.
  • 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
  • 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
  • Length of post-operative stay [ Time Frame: 3-months post-op ]
    Number of nights alive and in hospital after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial
Official Title  ICMJE The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bleeding Post Cardiac Surgery
  • Indication for Anticoagulation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: DOAC
  • 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.
    Intervention: Drug: VKA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2020)
5900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04284839
Other Study ID Numbers  ICMJE DANCE-2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Richard Whitlock, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emilie Belley-Cote, MD, MSc McMaster University
PRS Account McMaster University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP