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 |
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Health condition(s) or Problem(s) studied | Venous thromboembolism |
Date of first enrollment | 18/10/2018 |
Target sample size | 40 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Clot volume evaluated by contrast-enhanced CT imaging |
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Secondary Outcome | Recurrence of symptomatic DVT or PE, Hemorrhagic complications |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 74age old |
Gender | Both |
Include criteria | 1) 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 criteria | 1) 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
Primary Sponsor | Matoba Satoaki |
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Secondary Sponsor | |
Source(s) of Monetary Support | Bayer Yakuhin, Ltd |
Secondary ID(s) | UMIN000027793 |
Contact
Public contact | |
Name | Naohiko Nakanishi |
Address | 465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto Kyoto Japan 602-8566 |
Telephone | +81-75-251-5511 |
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 |
matoba@koto.kpu-m.ac.jp | |
Affiliation | University Hospital, Kyoto Prefectural University of Medicine |