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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

Must not have

Severe renal failure (Cockcroft-Gault equation; creatinine clearance <30 ml/min)

Antiphospholipid syndrome (triple positive)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 to 90-days post-randomization

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have atrial fibrillation and need blood thinners.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidneys are not working well (creatinine clearance <30 ml/min).

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I have been diagnosed with triple-positive antiphospholipid syndrome.

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I do not have severe liver disease.

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I have had heart surgery, including a device implant or heart transplant.

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I cannot take certain blood thinners due to health reasons.

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I have a condition that causes ongoing bleeding or easy bruising.

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I am pregnant, breastfeeding, or able to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 to 90-days post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 to 90-days post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 to 90-days post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemorrhage

Other study objectives

All Arterial Thrombosis/thromboembolism

All Stroke

All bleeding (major plus minor)

+8 more

Awards & Highlights

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.

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.

0 / 9Eligibility criteria met