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

Not Applicable

• Conditions: Venous thromboembolism

• Registration Number: JPRN-UMIN000027793
• Lead Sponsor: Kyoto Prefectural University of Medicine

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: 2017-06-17
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Patients contraindicated for rivaroxaban, with creatinine clearance <30 mL/min, with isolated distal DVT, within 6 months in the remaining days, with a vitamin K antagonist, with 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)), pregnancy, and breast-feeding. Patients who the physician in charge judges are ineligible for the present study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clot regression evaluated by contrast-enhanced CT imaging (Imaging is performed at baseline, 3 weeks and 3 months days after initiation of treatment).The ratio of clot volume regression after 3 weeks or 3 months compared with the clot volume at baseline is investigated. In addition, the rate of normalization (no thrombus in legs and lungs) is also investigated.

Secondary Outcome Measures

Name	Time	Method
1)Recurrence of symptomatic DVT or PE 2)Hemorrhagic complications Major bleeding:Clinically definite reduction in Hb by 2.0 g/dL or more, Bleeding requiring 2 units or more of transfusion, Intracranial hemorrhage, retroperitoneal hemorrhage, and bleeding to death Non-major bleeding: Bleeding clinically associated with rivaroxaban not meeting the criteria for major bleeding