Venous Thromboembolism Prophylaxis After Gynecological Pelvic Cancer Surgery With Rivaroxaban vs Enoxaparin

• Status: Recruiting
• Trial end date: 2024-07-15
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: André Luiz Malavasi Longo de Oliveira
• Collaborator: Science Valley Research Institute
• Treatments: Enoxaparin; Rivaroxaban

Criteria

Inclusion Criteria:

• Female patients 18 years of age or older

• Have undergone major gynecological cancer surgery (staging surgery, debulking surgery, -

• Total or radical hysterectomy, unilateral or bilateral salpingo-oophorectomy, omentectomy, lymph node removal, open or laparoscopic access)

• Have signed informed consent

• Have received thromboprophylaxis with low-molecular-weight heparin, fondaparinux, or unfractionated heparin during the index hospitalization

Exclusion Criteria:

• Age < 18 years

• Refusal of informed consent

• Physician decision that involvement in the trial was not in the patient's best interest

• Patients with a medical indication for anticoagulation therapy at the time of inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)

• Patients with contraindications to anticoagulation (active bleeding, liver failure, blood dyscrasia, or prohibitive hemorrhagic risk in the investigator's assessment)

• Active cancer (excluding non-melanoma skin cancer) defined as cancer not in remission or radiotherapy requiring active chemotherapy or adjunctive therapies such as immunotherapy

• Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or glycoprotein P (P-gp) (eg, protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong inducers of CYP3A4 (how but not limiting rifampicin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine or St. John's wort)

• Creatinine clearance <30 ml / min

• Pregnancy or breastfeeding

• Known HIV infection

• Presence of one of the following uncontrolled or unstable cardiovascular diseases:

stroke, ECG confirmed acute ischemia or myocardial infarction, and/or clinically significant dysrhythmia