Status:
UNKNOWN
Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports
Lead Sponsor:
LiuZhou People's Hospital
Conditions:
Rivaroxaban
Thromboprophylaxis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Age 18-75 years;
- Patients with malignant tumors who received implantable access ports for treatment;
- Eastern Cooperative Oncology Group (ECOG) class 0-1;
- will have a life expectancy \> 3 months;
- Expected survival of more than 6 months;
- Khorana score ≥2 point.
- Exclusion Criteria:
- Patients with a history of allergies to rivaroxaban;
- History of recent major or clinically relevant bleeding within the previous 4 weeks.
- Patients with bleeding risks: thrombocytopenia (platelet count \< 50\*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke; Inadequate renal function; creatinine clearance \< 30 ml/min；
- Inadequate hepatic function: aminotransferase \> 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase \> 5 times the ULN
- Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments.
- Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk.
- Patients who have had anticoagulant drugs for any other reason.
- Women who are pregnant or breastfeeding.
Exclusion
Key Trial Info
Start Date :
March 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 8 2022
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04309240
Start Date
March 8 2020
End Date
March 8 2022
Last Update
March 16 2020
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