Overview

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