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COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation

Study acronym: COBRRA-AF
StatusRecruiting
PhasePhase 4
Started2021-07-06
View on ClinicalTrials.gov ↗

Amendment history

2026-04-17
minor
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 8 sites
2025-11-14
minor
Study Status v10
Re-verified, no change to tracked fields
2025-04-01
minor
Study Status, Outcome Measures, Contacts/Locations v9
Primary completion date2026-12-31→2027-12-31
Completion date2026-12-31→2027-12-31
Secondary endpoints8 to 6 entries
Adjudicated stroke/TIA events Incremental cost-effectiveness per one CRB case prevented cost per one life year saved cost per one quality-adjusted life year (QALY) gainedratio
Study sitescontacts updated at 1 of 8 sites
2024-10-11
minor
Study Status v8
Primary completion date2025-12-31→2026-12-31
2024-04-26
minor
Study Status, Contacts/Locations v7
Study sites5→8
Show 6 earlier versions
2023-10-03
minor
Study Identification, Study Status, Study Description, Contacts/Locations v6
Study description+1,275 characters
Atrial Fibrillation (AF) affects 200,000 Canadians and increases risk of stroke, morbidity and mortality. Oral anticoagulants such as Vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are highly effective at reducing the risk of stroke by up to 95%. Randomized controlled trials (RC [...]
Study sitesdetails revised at 3 of 5 sites
2023-04-20
minor
Study Identification, Study Status, Contacts/Locations, IPDSharing v5
Study sites1→5
2022-03-14
minor
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2021-10-29
minor
Study Status, Contacts/Locations v3
Re-verified, no change to tracked fields
2021-09-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-03-15→confirmed 2021-07-06
Study sitesdetails revised at 1 of 1 site
2021-02-22
minor
Study Status, Contacts/Locations v1
Start date2021-01-29→2021-03-15
2020-11-19
minor
Original filing
Atrial Fibrillation (AF) affects 200,000 Canadians and increases risk of stroke, morbidity and mortality. Having a stroke can affect a patient's ability to speak, eat, walk, work, care for themselves, and interact with others. Not only can it ruin one's life, but it can also be fatal. A stroke occurs when blood flow to the brain is blocked by a clot, depriving brain cells of oxygen. In people with atrial fibrillation, blood flow is sluggish in the top chambers of the heart, and blood clots can form there. When a piece of a clot breaks off, it can travel to the brain and cause a stroke. That's where blood thinners come in. Blood thinners, or anticoagulants, decrease the chances of blood clots forming in the heart, reducing the risk of stroke. Studies show that blood thinners are highly effective at reducing the risk of stroke by up to 95%. The conventional blood thinner is warfarin, taken by mouth. Warfarin requires regular blood tests to make sure a patient getting the correct dose. The patient also may have to avoid certain foods since the medication can interact with them. Newer blood thinners, known as direct-oral anticoagulants (DOACs) are available, which do not require regular blood tests and do not interact with foods. Two of the new blood thinners are called rivaroxaban and apixaban. Like warfarin, they can be taken by mouth, and studies have shown them to be as effective as warfarin. Both rivaroxaban and apixaban have been approved for stroke prevention in AF by Health Canada. However, there have been no direct head-to-head comparisons of these two anticoagulants, meaning comparative safety data is not available. Increasing use of DOACs for stroke prevention in AF and patient values around bleeding highlight the need for a comparison trial to ensure patients receive the anticoagulant with the greatest balance of benefit to potential harm. The trial is to assess bleeding rates and superiority of using apixaban versus rivaroxaban in patients with non-valvular atrial fibrillation.
Trial Details
NCT Number NCT04642430
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, Canadian Institutes of Health Research (CIHR)
Conditions Atrial Fibrillation
Enrollment 3,018 participants
Start Date 2021-07-06
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-10-01