OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial

PHASE3RECRUITING

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 atrial fibrillation requiring oral anticoagulation.

Study details:

Approximately 36,000 Canadian adults undergo cardiac surgery annually. Of these patients, about 10% have a prior history of atrial fibrillation (AF). In the early post-operative period after cardiac surgery, 30-60% of patients develop AF and, by the time of discharge, 32% of patients who underwent cardiac surgery have an indication for oral anticoagulation (OAC).

AF is associated with a significantly higher risk of stroke, even when transient, and OAC is the standard for thromboembolic prevention in these patients. In the post-operative period, the balance of benefits and risks of OAC may differ and the safest and most effective OAC in that patient population is uncertain. Vitamin K antagonists (VKAs), such as warfarin or coumadin, are the most used anticoagulants after cardiac surgery.

In the Left Atrial Appendage Occlusion Study (LAAOS) III that recruited 4811 patients from 105 centres in 27 countries, 77% of patients with AF on OAC were discharged on a VKA after cardiac surgery. Among patients taking a DOAC preoperatively, 55% were switched to a VKA after surgery. Over the first post-operative year, most of those patients were gradually transitioned back to a DOAC.

Although effective, the use of VKAs 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 addition, in the first 3 months after cardiac surgery, time in the therapeutic range is low, even with close monitoring by experienced prescribers.

In the last decade, DOACs - inhibitors of factor Xa or thrombin- have become broadly used in patients with AF. Treatment with a DOAC in patients with AF has been demonstrated to yield a lower risk of stroke or systemic embolism and a similar risk of major bleeding when compared to VKAs 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. In the postoperative setting, DOACs may also lead to shorter length of stay and reduced costs. 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. A subset of 910 DANCE participants with a recent bioprosthetic aortic and/or mitral valve replacement will be enrolled in the SUNDANCE substudy (Subclinical valve thrombosis in patients with surgical bioprosthetic valve replacement: An imaging substudy of the DANCE trial). SUNDANCE will examine the effects of DOACs versus VKAs on subclinical valve thrombosis and bioprosthetic valve function by conducting computed tomography (CT) scans and echocardiograms at 60 to 90 days after randomization.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Age ≥18 years at the time of enrolment
  2. Open heart surgery in the last 10 days
  3. Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation)
  4. 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 <15 ml/min)
  4. Known significant liver disease (Child-Pugh classification B and C)
  5. Left ventricular thrombus
  6. Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis
  7. Known contraindication for any DOAC or VKA
  8. Women who are pregnant, breastfeeding, or of childbearing potential
  9. Surgery including left ventricular assist device implantation or cardiac transplantation
  10. Previously enrolled in this trial
  11. Follow-up not possible
  12. History of moderate or severe mitral valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT04284839

Intervention or treatment

DRUG: DOAC

DRUG: VKA

Conditions

  • Bleeding Post Cardiac Surgery
  • Indication for Anticoagulation

  • Condition: Bleeding Post Cardiac Surgery, Indication for Anticoagulation

  • DRUG: DOAC and other drugs

  • Fitzroy, Victoria, Australia and more

  • Sponsor: Population Health Research Institute

Save

Share

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

St Vincent's Hospital Melbourne

Select from list below to view details:

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, Australia

  • Royal Melbourne Hospital, University of Melbourne

    Parkville, Victoria, Australia

Loading map...

Who is running the clinical trial?

PHRI

Population Health Research Institute

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/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
    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

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Major BleedingMajor bleeding at 30 days, defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) 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 or whole blood (as defined by the International Society of Thrombosis and Hemostasis)30-Days post-randomization

      Secondary Outcome

      MeasureDescriptionTime Frame
      Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days.Not Specified30-Days and 90-Days post-randomization
      Major BleedingNot Specified90-Days post-randomization
      Pleural or pericardial effusion requiring drainageNot Specified30-Days and 90-Days post-randomization
      Systemic arterial embolismNot Specified30-Days and 90-Days post-randomization
      Ischemic strokeNot Specified30-Days and 90-Days post-randomization
      Deep vein thrombosisNot Specified30-Days and 90-Days post-randomization
      Pulmonary EmbolismNot Specified30-Days and 90-Days post-randomization
      Length of post-operative hospital stayNot Specified30-Days and 90-Days post-randomization
      All-Cause MortalityNot Specified6 Months post-randomization
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial

      Other trials to consider

      Loading suggested trials...

      Top searched conditions

      Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular