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

NCT04309240 | Unknown Phase 3

• 1 other identifier: KY-1-2020-07-01
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rivaroxaban; Thromboprophylaxis; Cancer

Keywords

Prophylactic Anticoagulation; rivaroxaban; venous thrombosis; Totally Implantable Access Ports; cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

rivaroxaban

EXPERIMENTAL

oral Rivaroxaban 10mg per day for 90days

Drug: Rivaroxaban

blank control

NO INTERVENTION

mechanical prophylaxis

Interventions

Rivaroxaban DRUG

Rivaroxaban 10mg orally per day for 90days

rivaroxaban

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• LiuZhou People's Hospital: lead

Related 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.

  PMID: 30786186 BACKGROUND

• 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.

  PMID: 31353841 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Venous Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• yu bin, PHD

  LiuZhou People's Hospital

  STUDY CHAIR

Central Study Contacts

liu ting, master

CONTACT

13978872445; liuting201070176@163.com

yu bin, PHD

CONTACT

13877253868; 95197586@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 16, 2020
• Study Start: March 8, 2020
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share