Comparing two types of blood thinners after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St Vincent's Hospital Melbourne
  Fitzroy, Victoria, Australia 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
• Health Science Centre
  St. John's, Newfoundland and Labrador, Canada Recruiting
• Health Sciences North Research Institute
  Greater Sudbury, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Emilie Belley-Cote, MD, MSc — McMaster University
• Study coordinator: Emilie Belley-Cote, MD, MSc
• Email: emilie.belley-cote@phri.ca
• Phone: 905-527-4322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.