NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051180077

Registered date:27/02/2019

Clot regression effects of rivaroxaban in treatment of venous thromboembolism in cancer patients.

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedVenous thromboembolism
Date of first enrollment18/10/2018
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)VTE patients receive the NHI-covered standard rivaroxaban treatment (30 mg/day for 3 weeks after initiation of treatment, followed by 15 mg/day)

Outcome(s)

Primary OutcomeClot volume evaluated by contrast-enhanced CT imaging
Secondary OutcomeRecurrence of symptomatic DVT or PE, Hemorrhagic complications

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 74age old
GenderBoth
Include criteria1) Patients with active cancer* at diagnosis with VTE (symptomatic or asymptomatic) 2) Untreated VTE 3) Patients aged 20 to 75 years 4) Patient signed the imformed consent to participate in this study *Active cancer at baseline was defined as a diagnosis of cancer that occurred within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer
Exclude criteria1) Patients contraindicated for rivaroxaban 2) Rivaroxaban therapy within 30 days before informed consent 3) Fibrinolytic therapy within 30 days before informed consent 4) Creatinine clearance <30 mL/min 5) Life expectancy <6 months 6) Isolated distal DVT 7) Treatment with vitamin K antagonist 8) Severe complication (significant liver disease, active bleeding or a high risk of bleeding contraindicating anticoagulant treatment, severe hypertension (a systolic blood pressure of more than 180 mm Hg or a diastolic blood pressure of more than 110 mm Hg)) 9) Pregnancy, and breast-feeding 10) Individuals who are scheduled to participate in other interventional study during this study 11) Surgical operation is scheduled during this study 12) Contraindicated for contrast agent/ Allergic reaction to contrast agent 13) Patients who the physician in charge judges ineligible for the present study

Related Information

Contact

Public contact
Name Naohiko Nakanishi
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto Kyoto Japan 602-8566
Telephone +81-75-251-5511
E-mail naka-nao@koto.kpu-m.ac.jp
Affiliation University Hospital, Kyoto Prefectural University of Medicine
Scientific contact
Name Satoaki Matoba
Address 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto Kyoto Japan 602-8566
Telephone +81-75-251-5511
E-mail matoba@koto.kpu-m.ac.jp
Affiliation University Hospital, Kyoto Prefectural University of Medicine