Trial | NCT04309240  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    204
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.
Study Started
Mar 08
2020
Anticipated
Primary Completion
Mar 08
2022
Anticipated
Study Completion
Mar 08
2022
Anticipated
Last Update
Mar 16
2020

Drug Rivaroxaban

Rivaroxaban 10mg orally per day for 90days

rivaroxaban Experimental

oral Rivaroxaban 10mg per day for 90days

blank control No Intervention

mechanical prophylaxis

Criteria 

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.
No Results Posted