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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04284839




Registration number
NCT04284839
Ethics application status
Date submitted
24/02/2020
Date registered
26/02/2020

Titles & IDs
Public title
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Scientific title
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Secondary ID [1] 0 0
DANCE-2020
Universal Trial Number (UTN)
Trial acronym
DANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bleeding Post Cardiac Surgery 0 0
Indication for Anticoagulation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DOAC
Treatment: Drugs - VKA

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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: VKA
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Bleeding
Timepoint [1] 0 0
30-Days post-randomization
Secondary outcome [1] 0 0
Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days.
Timepoint [1] 0 0
30-Days and 90-Days post-randomization
Secondary outcome [2] 0 0
Major Bleeding
Timepoint [2] 0 0
90-Days post-randomization
Secondary outcome [3] 0 0
Pleural or pericardial effusion requiring drainage
Timepoint [3] 0 0
30-Days and 90-Days post-randomization
Secondary outcome [4] 0 0
Systemic arterial embolism
Timepoint [4] 0 0
30-Days and 90-Days post-randomization
Secondary outcome [5] 0 0
Ischemic stroke
Timepoint [5] 0 0
30-Days and 90-Days post-randomization
Secondary outcome [6] 0 0
Deep vein thrombosis
Timepoint [6] 0 0
30-Days and 90-Days post-randomization
Secondary outcome [7] 0 0
Pulmonary Embolism
Timepoint [7] 0 0
30-Days and 90-Days post-randomization
Secondary outcome [8] 0 0
Length of post-operative hospital stay
Timepoint [8] 0 0
30-Days and 90-Days post-randomization
Secondary outcome [9] 0 0
All-Cause Mortality
Timepoint [9] 0 0
6 Months post-randomization

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
3500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Royal Melbourne Hospital, University of Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Germany
State/province [6] 0 0
Saxony
Country [7] 0 0
Germany
State/province [7] 0 0
Thuringen
Country [8] 0 0
Germany
State/province [8] 0 0
Bonn
Country [9] 0 0
Germany
State/province [9] 0 0
Essen
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Hamilton Health Sciences Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emilie Belley-Cote, MD, MSc
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emilie Belley-Cote, MD, MSc
Address 0 0
Country 0 0
Phone 0 0
905-527-4322
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04284839