Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial

Conditions
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Rivaroxaban, Thromboprophylaxis, Cancer

Intervention / Treatment
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* Drug: Rivaroxaban


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rivaroxaban<br>oral Rivaroxaban 10mg per day for 90days | Drug: Rivaroxaban<br>* Rivaroxaban 10mg orally per day for 90days<br>|
| No Intervention: blank control<br>mechanical prophylaxis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of venous thrombosis | detect the occurrence of venous thrombosis with ultrasound, venography if necessary. | 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 | 
| occurrence of a major bleeding event. | define occurrence of major-bleeding event with ISTH standard | 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 | 
| occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event | define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylactic Anticoagulation, rivaroxaban, venous thrombosis, Totally Implantable Access Ports, cancer