A Phase 3 interventional study of Rivaroxaban and Enoxaparin in Cancer, Rivaroxaban and Venous Thromboembolism, sponsored by André Luiz Malavasi Longo de Oliveira. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by André Luiz Malavasi Longo de Oliveira · Phase 3, Interventional, and Prevention
The Valeria trial will provide high-quality evidence regarding the efficacy and safety of oral rivaroxaban in thromboprophylaxis after gynecological pelvic cancer surgery in comparison with standard parenteral enoxaparin.
Cancer-associated thrombosis is the second leading cause of mortality in cancer patients, mainly due to the most common complication, venous thromboembolism (VTE). New oral antithrombotic strategies for VTE prevention after gynecological cancer surgery might be non-inferior to parenteral low-molecular-weight heparin (LMWH) in efficacy and safety with increased adherence, comfort, and reduced costs.
This is a multicenter, open-label, prospective, randomized, active-controlled study, and non-inferiority trial. Four hundred and forty patients submitted to major gynecological cancer surgery will be randomized in a 1:1 ratio to receive either oral rivaroxaban 10 mg once daily or subcutaneous enoxaparin 40mg once daily for 30 days post-operative. The primary efficacy outcome is a combination of symptomatic VTE and VTE-related death or VTE detected by mandatory Doppler ultrasound on day 30±4 post-operative. The primary safety outcome is the incidence of major and clinically relevant non-major bleeding according to the International Society on Thrombosis and Hemostasis criteria.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's planned enrollment of 440 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →This is the only study on the registry with André Luiz Malavasi Longo de Oliveira as lead sponsor.
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Exclusion Criteria:
Oral Rivaroxaban (10 mg once daily) for 30 days post-operative
Drug: Rivaroxaban
Subcutaneous Enoxaparin (40 mg once daily) for 30 days post-operative
Drug: Enoxaparin
Patients will be submitted to an initial screening evaluation during hospitalization. At discharge, they will be randomized and enrolled to be treated with oral rivaroxaban (10 mg once daily, for 30 days), once randomized to this group. A mandatory lower limb Doppler ultrasound will be carried out on day 30±4 as part of the primary efficacy endpoint. A final follow-up phone call visit will be performed on day 60 postoperative.
Also known as: Xarelto
Patients will be submitted to an initial screening evaluation during hospitalization. At discharge, they will be randomized and enrolled to be treated with subcutaneous enoxaparin (40 mg once daily, for 30 days), once randomized to this group. A mandatory lower limb Doppler ultrasound will be carried out on day 30±4 as part of the primary efficacy endpoint. A final follow-up phone call visit will be performed on day 60 postoperative.
Also known as: Clexane
Venous thromboembolism and VTE related-death
A composite of symptomatic objectively confirmed VTE (deep venous thrombosis, pulmonary embolism, and asymptomatic ultrasonography-confirmed, deep venous thrombosis or venous thromboembolism-related death at 30 days post-operative.
Time frame: At day 30 +/- post hospital discharge
Clinically relevant bleeding
A combination of major bleeding plus clinically relevant non-major bleeding at 30 days post-operative.
Time frame: At day 30 +/- post hospital discharge
A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death
A composite of myocardial infarction, stroke, arrhythmias, heart failure, venous thromboembolism (VTE), and all-cause death.
Time frame: At day 30 +/- post hospital discharge
Plan to share: No
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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