Clinical trial NCT04309240: Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports
Official title: The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rivaroxaban
Thromboprophylaxis
Cancer
Keywords: Prophylactic Anticoagulation
rivaroxaban
venous thrombosis
Totally Implantable Access Ports
cancer
Lead sponsor: LiuZhou People's Hospital
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: occurrence of venous thrombosis
timeFrame: 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
measure: occurrence of a major bleeding event.
timeFrame: 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
measure: occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LiuZhou People's Hospital
name: yu bin, PHD
role: STUDY_CHAIR
References:
citation: Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.
citation: Wang TF, Zwicker JI, Ay C, Pabinger I, Falanga A, Antic D, Noble S, Khorana AA, Carrier M, Meyer G. The use of direct oral anticoagulants for primary thromboprophylaxis in ambulatory cancer patients: Guidance from the SSC of the ISTH. J Thromb Haemost. 2019 Oct;17(10):1772-1778. doi: 10.1111/jth.14564. Epub 2019 Jul 28. No abstract available.