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

Sponsor

LiuZhou People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04309240

Collaborator

(none)

204

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rivaroxaban Thromboprophylaxis Cancer	Drug: Rivaroxaban	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 8, 2020

Anticipated Primary Completion Date :

Mar 8, 2022

Anticipated Study Completion Date :

Mar 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rivaroxaban oral Rivaroxaban 10mg per day for 90days	Drug: Rivaroxaban Rivaroxaban 10mg orally per day for 90days
No Intervention: blank control mechanical prophylaxis

Arm

Intervention/Treatment

Experimental: rivaroxaban

oral Rivaroxaban 10mg per day for 90days

Drug: Rivaroxaban

Rivaroxaban 10mg orally per day for 90days

No Intervention: blank control

mechanical prophylaxis

Outcome Measures

Primary Outcome Measures

occurrence of venous thrombosis [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]
detect the occurrence of venous thrombosis with ultrasound, venography if necessary.
occurrence of a major bleeding event. [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]
define occurrence of major-bleeding event with ISTH standard
occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event [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]
define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Eligibility Criteria:

Age 18-75 years;
Patients with malignant tumors who received implantable access ports for treatment;
Eastern Cooperative Oncology Group (ECOG) class 0-1;
will have a life expectancy > 3 months;
Expected survival of more than 6 months;
Khorana score ≥2 point.

Exclusion Criteria:

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.