Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2025-09-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban: The Pilot Study

NCT02559856

Venous Thromboembolism

COMPLETED PHASE4

Direct Oral Anticoagulants and Venous Thromboembolism

NCT02833987

Venous Thromboembolism Major Bleed

COMPLETED

Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- Clinical Trial

NCT05973188

Left Ventricular Thrombus

UNKNOWN PHASE4

Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

NCT01583218

Venous Thromboembolism (VTE)

COMPLETED PHASE3

Apixaban Versus Rivaroxaban in Non Valvular Atrial Fibrillation

NCT06862726

Non Valvular Atrial Fibrillation

ENROLLING_BY_INVITATION PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Thromboembolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Apixaban group

10 mg orally (PO), twice a day (BID) for 1 week, then 5 mg PO BID for 3 months of treatment

Group Type ACTIVE_COMPARATOR

Apixaban

Intervention Type DRUG

Refer to Apixaban group

Rivaroxaban group

15 mg orally (PO), twice a day (BID) for 3 weeks, then 20 mg PO once a day (OD) for 3 months of treatment

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

Refer to Rivaroxaban group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apixaban

Refer to Apixaban group

Intervention Type DRUG

Rivaroxaban

Refer to Rivaroxaban group

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eliquis Xarelto

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed newly diagnosed symptomatic acute venous thromboembolism (VTE) \[proximal lower extremity deep vein thrombosis (DVT) or segmental or greater pulmonary embolism (PE)\]
* Age ≥ 18 years old
* Informed consent obtained

Exclusion Criteria

* Have received \> 72 hours of therapeutic anticoagulation
* Creatinine clearance \< 30 ml/min calculated with the Cockcroft-Gault formula
* Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to:

* active bleeding,
* active malignancy, defined as a) diagnosed with cancer within the past 6 months; or b) recurrent, regionally advanced or metastatic disease; or c) currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or d) a hematologic malignancy not in complete remission,
* weight \> 120 kg,
* liver disease (Child-Pugh Class B or C),
* use of contraindicated medications
* another indication for long-term anticoagulation (e.g. atrial fibrillation)
* pregnant (note below) or breastfeeding (Note: as reported by the patient or a pregnancy test will be ordered at the discretion of the treating physician for women of childbearing potential as per standard of care)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No