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

JRCT ID: jRCTs051180077

Registered date:27/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Venous thromboembolism
• Date of first enrollment: 18/10/2018
• Target sample size: 40
• 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
• Secondary Outcome: Recurrence of symptomatic DVT or PE, Hemorrhagic complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• 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
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd
• Secondary ID(s): UMIN000027793