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Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these two anticoagulants. Lawsuits in the United States over bleeding events, patient perceptions, and concerns with medication adherence are additional factors highlighting the importance of a comparison trial.
This multi-center, pragmatic, prospective, randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of apixaban and rivaroxaban for the treatment of VTE.
Study details:
VTE is the third leading cause of mortality by cardiovascular disease. Standard treatment for acute VTE uses a combination of parenteral Low-Molecular-Weight Heparin (LMWH) and oral vitamin K antagonists (VKA) for 3 months, and carries significant bleeding risk. The major and/or clinically-relevant non-major bleeding (CRNMB) event rate is reported between 8.
1-9. 7% during initial treatment. This treatment is burdensome owing to subcutaneous injections, drug interactions, and laboratory monitoring.
Direct oral anticoagulants (DOACs) are simpler to use and do not require laboratory monitoring. Rivaroxaban and apixaban are two DOACs targeting Factor Xa. Each DOAC was separately proven effective and safe when compared to standard treatment.
Comparison of the bleeding rates between studies would favour use of apixaban over rivaroxaban; however, trial limitations and lack of direct comparison between these two agents makes it impossible to draw firm conclusions. This represents a dilemma in clinical practice because the absence of convincing differences in safety has led to genuine uncertainty about which DOAC has the best risk-to-benefit ratio. To address these limitations, a head-to-head randomized controlled trial (RCT) is needed to determine the safety (i.
e. bleeding risk) of twice daily apixaban over once daily rivaroxaban during the first 3 months of acute VTE treatment. Eligibility criteria will be less stringent than the COBRRA pilot study and reflect real-world patients.
Cost-effective analysis of apixaban twice daily compared to rivaroxaban once daily will also be performed.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2017-12-13
Primary completion: 2024-12-31
Study completion finish: 2024-12-31
Study type
TREATMENT
Phase
PHASE4
Trial ID
NCT03266783
Intervention or treatment
DRUG: Apixaban
DRUG: Rivaroxaban
Conditions
- • Venous Thromboembolism
Find a site
Closest Location:
The University of Sydney
Research sites nearby
Select from list below to view details:
The University of Sydney
Darlington, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Apixaban group
| DRUG: Apixaban
|
ACTIVE_COMPARATOR: Rivaroxaban group
| DRUG: Rivaroxaban
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
The rate of adjudicated clinically relevant bleeding (CRB) events | CRB events are defined as the composite of major bleeding (MB) events and clinically relevant non-major bleeding (CRNMB) events. | For the duration of the study: 3 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Adjudicated Major Bleeding events | Not Specified | For the duration of the study: 3 months |
Adjudicated Clinically Relevant Non-Major Bleeding events | Not Specified | For the duration of the study: 3 months |
Adjudicated recurrent VTE events | Not Specified | For the duration of the study: 3 months |
Adjudicated VTE-related deaths | Not Specified | For the duration of the study: 3 months |
All-cause mortality | Not Specified | For the duration of the study: 3 months |
Medication adherence | Not Specified | For the duration of the study: 3 months |
Quality-adjusted life years (QALYs) gained | Not Specified | For the duration of the study: 3 months |
Incremental cost-effectiveness ratio | Not Specified | For the duration of the study: 3 months |
Impact of verbal consent on patient participation in comparison with participants from sites using written informed consent | Not Specified | For the duration of the study: 3 months |
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