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COmparison of Bleeding Risk between Rivaroxaban and Apixaban for the treatment of acute venous thromboembolism
EU CTIS ID: 2023-504179-26-00
What this study is testing
To compare the safety of apixaban and rivaroxaban for treatment of VTE.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Symptomatic acute VTE (proximal lower extremity DVT or segmental or greater PE) Age ≥ 18 years old Provide informed consent - Ability to comprehend the Patient Information Leaflet and to provide signed and dated informed consent - Women of childbearing potential must be using effective contraception (see section 5.3 of main protocol) - Negative urine pregnancy test at Visit 1 required for all females including those presenting with oligomenorrhea or amenorrhea who are ≤55 years (unless permanently sterile)
You likely can't join if
- Have received > 72 hours of therapeutic anticoagulation
- Creatinine clearance < 30 ml/min calculated with the Cockcroft-Gault formula
- Use of any other investigational medicinal product within previous 12 weeks
- Co-enrolment in another trial of an investigational medicinal product
- • Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 of the SmPC for Rivaroxaban or Apixaban
- • Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to: o active bleeding, o active malignancy, defined as the following: 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, o weight >120 kg, o hepatic disease associated with coagulopathy and clinically relevant bleeding risk o known liver disease (Child-Pugh B or C), o use of contraindicated medications (see Section 6.4) o another indication for long-term anticoagulation (e.g. atrial fibrillation) o pregnant* or breastfeeding *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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.