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Serine

Rivaroxaban 10mg orally per day for 90days

liu ting, master

yu bin, PHD

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.

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

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

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

define occurrence of major-bleeding event with ISTH standard

define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0

LiuZhou People's Hospital

Principal Investigator

Embolism

Embolism and Thrombosis

Vascular Diseases

Fibrinolytic Agents

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Platelet Aggregation Inhibitors

Heparin

Aspirin

Calcium heparin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Rivaroxaban 10mg

Aspirin 100mg

low molecule heparin

Jian Huang, Doctor

Gui Nv Hu, Doctor

Wen J Chen, Doctor

Pei F Fu, Doctor

Zhi Y Feng

Zhen Y Wang, Doctor

Jing P Long, Doctor

Xiao H Xie, Doctor

Gui P Chen, Doctor

Xiao C Wang, Doctor

Shi L Tu, Doctor

Yun H Wei, Doctor

Shu Z Fang, Doctor

Juan Y Zhu, Doctor

Shu G Li, Doctor

Shu Z Chen, Doctor

Qing H Shen, Doctor

Yong Shi, Doctor

Yi J Mei, Doctor

Jia M Lei, Doctor

Lv J Cen, Doctor

Yan Zhang, Doctor

Ying J Wu, Doctor

Zhan W Li, Doctor

Jian Zhang, Doctor

Ou C Wang, Doctor

Min Zheng, Doctor

Jing Xu, Doctor

The main objective of this study is to compare the efficacy and safety of aspirin, low molecule heparin and rivaroxaban for preventing catheter-related thrombosis in middle-to-high-risk ambulatory patients with cancer and implantable venous access ports.

Study Type: Interventional, randomized, parallel Assignment and no masking

Study Arms \& Intervention: Drug 1: Aspirin, 100mg/day orally; Drug 2: rivaroxaban, 10mg/day orally; Drug 3: low molecule heparin, 4000IU(0.4ml)/day subcutaneous injection; Reference: mechanical prophylaxis.

Follow-up Period: 6 months. The trial visits occurred at time before each chemotherapy cycle. The following details should be included at each visit: Khorana score, height and weight, blood routine examination, coagulation function, stool-routine and occult blood test, renal and liver function, ultrasonography of both legs and neck.

Primary Outcome: The primary efficacy end point was the occurrence of thrombus in the vein at the puncture site or nearby. The primary was the occurrence of a major bleeding event as defined by the International Society on Thrombosis and Haemostasis (ISTH).

Secondary Outcome: The secondary efficacy end point was occurrence of occurrence of other thrombosis or embolism events like deep vein thrombosis or pulmonary embolism. The secondary safety endpoint was the occurrence of any clinically relevant non-major bleeding, minor bleeding and adverse events.

Population: patients with cancer and implantable venous access ports

Eligibility Criteria:

1. Age 18-75 years;
2. Patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
3. Eastern Cooperative Oncology Group (ECOG) class 0-1;
4. Expected to receive chemotherapy within 1 week of enrollment;
5. Expected survival of more than 6 months;
6. Ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
7. Khorana score 1-3 point.

Exclusion Criteria:

1. Patients with a history of allergies to low molecular weight heparin, rivaroxaban, aspirin or other non-steroidal anti-inflammatory drugs, especially those with asthma, neurovascular edema or shock;
2. 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;
3. moderate to severe liver and kidney dysfunction;
4. pregnant or lactating women;
5. patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
6. Patients taking methotrexate;
7. Patients with systemic use of non-steroidal anti-inflammatory drugs;
8. Patients who have had anticoagulant drugs for any other reason.

Prophylactic Anticoagulation for Catheter-related Thrombosis

The Efficacy and Safety of Prophylactic Anticoagulation for Catheter-related Thrombosis in Patients With Cancer and Implantable Venous Access Ports: a Prospective Multi-center Randomized Controlled Trial.

detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary

detect deep vein thrombosis with ultrasound for the lower extremity, , ultrasound for the upper extremity, pulmonary arteriography or venography if necessary

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports	NCT04309240	Rivaroxaban Thromboprophyla... Cancer	Rivaroxaban	18 Years - 75 Years	LiuZhou People's Hospital
Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports	NCT04309240	Rivaroxaban Thromboprophyla... Cancer	Rivaroxaban	18 Years - 75 Years	LiuZhou People's Hospital
Prophylactic Anticoagulation for Catheter-related Thrombosis	NCT04256525	Venous Thrombos... Prophylactic An... Patients With T...	Rivaroxaban 10m... Aspirin 100mg low molecule he...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University

Spots Global Cancer Trial Database for prophylactic anticoagulation