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

NCT ID: NCT04309240

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-08
• Study Completion Date: 2022-03-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rivaroxaban

oral Rivaroxaban 10mg per day for 90days

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

Rivaroxaban 10mg orally per day for 90days

blank control

mechanical prophylaxis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rivaroxaban

Rivaroxaban 10mg orally per day for 90days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LiuZhou People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

tingliu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yu bin, PHD

Role: STUDY_CHAIR

LiuZhou People's Hospital

Central Contacts

liu ting, master

Role: CONTACT

liuting201070176@163.com

13978872445

yu bin, PHD

Role: CONTACT

95197586@qq.com

13877253868

References

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.

Reference Type: BACKGROUND

PMID: 30786186 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31353841 (View on PubMed)

Other Identifiers

KY-1-2020-07-01

Identifier Type: -

Identifier Source: org_study_id