Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports
- Registration Number
- NCT04309240
- Lead Sponsor
- LiuZhou People's Hospital
- 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 with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 204
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rivaroxaban Rivaroxaban oral Rivaroxaban 10mg per day for 90days
- Primary Outcome Measures
Name Time Method occurrence of venous thrombosis From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months detect the occurrence of venous thrombosis with ultrasound, venography if necessary.
occurrence of a major bleeding event. From date of randomization until the date of occurrence of a major bleeding event or date of death from any cause, whichever came first, assessed up to 6 months define occurrence of major-bleeding event with ISTH standard
occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event From date of randomization until the date of occurrence of events or date of death from any cause, whichever came first, assessed up to 6 months define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0
- Secondary Outcome Measures
Name Time Method