Clinical trial · Interventional

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

NCT04309240CI-TRIAL-00044035unknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90
Rivaroxaban	—	UNRESOLVED	—
Thromboprophylaxis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Rivaroxaban	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
rivaroxaban
description
oral Rivaroxaban 10mg per day for 90days
interventionNames
1. Drug: Rivaroxaban
type
NO_INTERVENTION
label
blank control
description
mechanical prophylaxis

Primary outcomes (3)

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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (2)

BACKGROUNDKhorana 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
BACKGROUNDWang 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