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

Phase 4

• Conditions: Venous thromboembolism

• Registration Number: JPRN-jRCTs051180077
• Lead Sponsor: Matoba Satoaki

Brief Summary

This study revealed that rivaroxaban had a sufficient clot-regression effect for the treatment of VTE in cancer patients. It exhibited an acceptable safety profile; however, future clinical use in patients with gastrointestinal or genitourinary cancers should be met with caution.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Study Completion: 2021-10-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified