Comparing two types of blood thinners after heart surgery

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

This study is testing which type of blood thinner is safer for people who have had heart surgery and need it to prevent strokes from atrial fibrillation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Population Health Research Institute (Academic / other)
• Locations: 19 sites (Fitzroy, Victoria and 18 other locations)
• Trial ID: NCT04284839 on ClinicalTrials.gov

What this trial studies

This trial compares the safety of direct oral anticoagulants (DOAC) with vitamin K antagonists (VKA) in patients who have undergone cardiac surgery and require anticoagulation due to atrial fibrillation. It involves a multi-centre, randomized controlled design, enrolling patients within 10 days post-surgery. The study aims to determine which anticoagulant is safer and more effective during the early post-operative period, addressing the high risk of stroke associated with atrial fibrillation. Approximately 36,000 adults undergo cardiac surgery in Canada annually, with a significant portion requiring anticoagulation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone open heart surgery within the last 10 days and have atrial fibrillation requiring anticoagulation.

Not a fit: Patients with mechanical valve replacements, severe renal failure, or ongoing bleeding disorders are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could identify a safer and more effective anticoagulation strategy for patients after cardiac surgery, potentially reducing the risk of stroke.

How similar studies have performed: Previous studies have shown varying success with anticoagulation strategies in similar populations, but this specific comparison of DOAC versus VKA in the post-operative setting is novel.

Eligibility criteria

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.

Where this trial is running

Fitzroy, Victoria and 18 other locations

• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (Recruiting)
• Royal Melbourne Hospital, University of Melbourne — Parkville, Victoria, Australia (Not_yet_recruiting)
• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
• University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
• St. Boniface Hospital — Winnipeg, Manitoba, Canada (Recruiting)
• Saint John Regional Hospital — Saint John, New Brunswick, Canada (Active_not_recruiting)
• Health Science Centre — St. John's, Newfoundland and Labrador, Canada (Recruiting)
• Health Sciences North Research Institute — Greater Sudbury, Ontario, Canada (Recruiting)
• Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
• Sunnybrook Hospital — Toronto, Ontario, Canada (Recruiting)
• Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• Hôpital Sacré-Coeur de Montréal — Montreal, Quebec, Canada (Active_not_recruiting)
• IUCPQ-ULaval — Québec, Quebec, Canada (Recruiting)
• Heart Center Leipzig — Leipzig, Saxony, Germany (Active_not_recruiting)
• University Hospital Jena — Jena, Thuringia, Germany (Recruiting)
• University Hospital Bonn Heart Center — Bonn, Germany (Active_not_recruiting)
• West-German Heart and Vascular Center, University of Duisburg-Essen — Essen, Germany (Not_yet_recruiting)
• University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)

Study contacts

• Principal investigator: Emilie Belley-Cote, MD, MSc — McMaster University
• Study coordinator: Emilie Belley-Cote, MD, MSc

Conditions Bleeding Post Cardiac Surgery; Indication for Anticoagulation; Direct Oral Anticoagulant; Vitamin K Antagonist; Bleeding