Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Population Health Research Institute
Registry number NCT04284839
Started 18 July 2021 Today 16 October 2026 Estimated completion 1 June 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
St Vincent's Hospital Melbourne Fitzroy VIC Recruiting
Royal Melbourne Hospital, University of Melbourne Parkville VIC Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 3500

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 18 July 2021
Estimated completion 1 June 2027
Registry last updated 18 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 18 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.