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

Phase

Condition

Dysrhythmia

Arrhythmia

Chest Pain

Treatment

Rivaroxaban

Apixaban

Clinical Study ID

NCT04642430

COBRRA-AF

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age ≥ 18 years old
Confirmed new diagnosis of AF on ECG with an indication to start anticoagulationaccording to Canadian Cardiovascular Society guidelines

Exclusion

Exclusion Criteria:

Creatinine clearance =<15 ml/min calculated using the Cockcroft-Gault formula
Any contraindication for anticoagulation with apixaban or rivaroxaban as determinedby the treating physician such as, but not limited to:
active bleeding
history of mechanical valve
other indication for anticoagulation (e.g. mechanical valves, venousthrombosis)
dual antiplatelet agent use
known liver disease with coagulopathy
use of contraindicated medications (strong inducers/inhibitors of CYP 3A4/5,P-glycoprotein)
pregnancy or breastfeeding

Study Design

Rivaroxaban

July 06, 2021

December 31, 2027

Study Description

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 (RCTs) have compared apixaban and rivaroxaban (both DOACs) to VKAs for stroke prevention in AF, and are approved for this use 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, patient values around bleeding, and litigation highlight the need for a comparison trial to ensure patients receive the anticoagulant with the greatest balance of benefit to potential harm.

The objective of this RCT is to compare the safety of the first 12 months of apixaban twice daily to rivaroxaban once daily in patients with non-valvular AF (NVAF). Patients will be monitored for the primary outcome of clinically relevant bleeding (CRB; a composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) events during follow-up. This trial will directly inform clinical practice and the choice of first-line therapy.

Connect with a study center

Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia V8Z 0B9
Canada
Site Not Available
Victoria Cardiac Arrhythmia Trials
Victoria 6174041, British Columbia 5909050 V8Z 0B9
Canada
Active - Recruiting
QEII Health Science Centre
Halifax, Nova Scotia
Canada
Site Not Available
QEII Health Science Centre
Halifax 6324729, Nova Scotia 6091530
Canada
Active - Recruiting
Kingston General Hospital
Kingston, Ontario
Canada
Site Not Available
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H 8L6
Canada
Active - Recruiting
University Ottawa Heart Institute
Ottawa, Ontario
Canada
Site Not Available
Kingston General Hospital
Kingston 5992500, Ontario 6093943
Canada
Active - Recruiting
The Ottawa Hospital - General Campus
Ottawa 6094817, Ontario 6093943 K1H 8L6
Canada
Active - Recruiting
University Ottawa Heart Institute
Ottawa 6094817, Ontario 6093943
Canada
Active - Recruiting
CISSS de l'Outaouais
Gatineau, Quebec J8T 4J3
Canada
Site Not Available
CHU de Quebec - Université Laval
Laval, Quebec
Canada
Site Not Available
Ciusss Nim
Montreal, Quebec H3L 1K5
Canada
Site Not Available
Université Laval
Québec, Quebec
Canada
Site Not Available
CISSS de l'Outaouais
Gatineau 5959974, Quebec 6115047 J8T 4J3
Canada
Active - Recruiting
CHU de Quebec - Université Laval
Laval 6050610, Quebec 6115047
Canada
Site Not Available
Ciusss Nim
Montreal 6077243, Quebec 6115047 H3L 1K5
Canada
Site Not Available

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