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Anticoagulant
DOAC vs Warfarin as Blood Thinners After Heart Surgery (DANCE Trial)
Phase 3
Recruiting
Led By Emilie Belley-Cote, MD, MSc
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation)
Age ≥18 years at the time of enrolment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-randomization
Awards & highlights
DANCE Trial Summary
This trial is comparing the safety of two types of blood thinners in the early days after heart surgery.
Who is the study for?
This trial is for adults over 18 who've had open heart surgery within the last 10 days and need blood thinners due to atrial fibrillation. It's not for those with severe kidney or liver disease, ongoing bleeding issues, mechanical heart valves, or women who are pregnant or could become pregnant.Check my eligibility
What is being tested?
The DANCE Trial compares new blood thinners (DOAC) with traditional ones (VKA) right after cardiac surgery in patients with atrial fibrillation. Participants will be randomly assigned to one of these treatments to test safety over a period of 30 days.See study design
What are the potential side effects?
Possible side effects include bleeding risks associated with both DOACs and VKAs. These can range from minor bruising to more serious internal bleeding. Kidney function may also be affected by these medications.
DANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have atrial fibrillation and need blood thinners.
Select...
I am 18 years old or older.
DANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
All-Cause Mortality
Nervous system structure
Deep vein thrombosis
+6 moreOther outcome measures
All Arterial Thrombosis/thromboembolism
All Stroke
All bleeding (major plus minor)
+10 moreDANCE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Direct Oral Anticoagulation (DOAC)Active Control1 Intervention
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.
Group II: Vitamin K AntagonistPlacebo Group1 Intervention
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Find a Location
Who is running the clinical trial?
Population Health Research InstituteLead Sponsor
156 Previous Clinical Trials
677,632 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
297,466 Total Patients Enrolled
Emilie Belley-Cote, MD, MScPrincipal InvestigatorMcMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had open heart surgery in the last 10 days.It's not possible to keep in touch with you after the study.My kidneys are not working well (creatinine clearance <30 ml/min).I have been diagnosed with triple-positive antiphospholipid syndrome.I do not have severe liver disease.I have had heart surgery, including a device implant or heart transplant.I have atrial fibrillation and need blood thinners.I cannot take certain blood thinners due to health reasons.I have a condition that causes ongoing bleeding or easy bruising.You have a mechanical heart valve.I am pregnant, breastfeeding, or able to become pregnant.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin K Antagonist
- Group 2: Direct Oral Anticoagulation (DOAC)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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