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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04309240
• Other study ID #: KY-1-2020-07-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 8, 2020
• Est. completion date: March 8, 2022

Study information

• Verified date: March 2020
• Source: LiuZhou People's Hospital
• Contact: liu ting, master
• Phone: 13978872445
• Email: liuting201070176[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Rivaroxaban
• Thromboprophylaxis

Intervention

Drug:
• Rivaroxaban
Rivaroxaban 10mg orally per day for 90days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LiuZhou People's Hospital

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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