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

LiuZhou People's Hospital204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

204

Conditions

Rivaroxaban Thromboprophylaxis Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Eligibility Criteria: 1. Age 18-75 years; 2. Patients with malignant tumors who received implantable access ports for treatment; 3. Eastern Cooperative Oncology Group (ECOG) class 0-1; 4. will have a life expectancy \> 3 months; 5. Expected survival of more than 6 months; 6. Khorana score ≥2 point. Exclusion Criteria: 1. Patients with a history of allergies to rivaroxaban; 2. History of recent major or clinically relevant bleeding within the previous 4 weeks. 3. 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； 4. Inadequate hepatic function: aminotransferase \> 3 times the upper limit of normal (ULN) (if liver metastasis, alanine aminotransferase \> 5 times the ULN 5. Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease inhibitor, systemic ketoconazole) treatments. 6. Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk. 7. Patients who have had anticoagulant drugs for any other reason. 8. Women who are pregnant or breastfeeding.

Outcomes

Primary Outcomes

occurrence of venous thrombosis

detect the occurrence of venous thrombosis with ultrasound, venography if necessary.

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

liu ting, master

CONTACT

13978872445 liuting201070176@163.com

yu bin, PHD

CONTACT

13877253868 95197586@qq.com