RecruitingPhase 2ACTRN12617000331336

Anticoagulant therapy for cancer-associated blood clots

A Phase 2 study of safety of Rivaroxaban compared with Low Molecular Weight Heparin (LMWH) for acute therapy of cancer-associated venous thromboembolism

Sponsor

South East Sydney and Illawarra Area Health Service

Enrollment

600 participants

Start Date

Apr 4, 2017

Study Type

Interventional

Conditions

Venous Thromboembolism Pulmonary Embolism Deep Vein Thrombosis

Summary

The primary purpose of this trial is to evaluate the safety of rivaroxaban for the treatment of thrombosis associated with cancer, in comparison to the standard care treatment with low molecular weight heparin (LMWH). Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have active cancer and require therapeutic anticoagulation for a new diagnosis of deep vein thrombosis or pulmonary embolism. The duration of anticoagulant treatment should be for at least 6 months. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either treatment with rivaroxaban or treatment as per standard care with LMWH for at least 6 months. Patients can either be enrolled within 72 hours of diagnosis, or at day 30 +/- 2 days. Participants will be assessed six months later for side effects of treatment, including any bleeding which has occurred. It is hoped that the findings from this trial will provide information on whether rivaroxaban is a safe alternative to LMWH for the treatment of cancer-associated thrombosis.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two blood thinners — rivaroxaban (a tablet) and low molecular weight heparin (an injection) — for treating blood clots (deep vein thrombosis or pulmonary embolism) in people who have active cancer. The main goal is to find out if rivaroxaban is a safe and easier-to-use alternative to daily injections. You may be eligible if: - You are 18 years of age or older - You have an active cancer diagnosis - You have recently been diagnosed with a blood clot (DVT or pulmonary embolism) - You need blood-thinning treatment for at least 3 months - You are able to attend follow-up clinic appointments You may NOT be eligible if: - You have severe kidney impairment (GFR below 30) - You have significant liver disease - You have had a serious bleed in the last 4 weeks requiring hospitalization or surgery - You are pregnant or could become pregnant without adequate contraception - Your expected survival is less than 6 months or you are too unwell to leave bed (ECOG 4) - You are geographically unable to attend follow-up Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Study intervention will be commenced immediately after randomisation and within 72 hours (cohort R1) or between 30 +/- 2 days (cohort R2) after commencement of therapeutic anticoagulation according to initial consent and election for treatment. Standard of care anticoagulant therapy is low molecular weight heparin of choice injected subcutaneously (protocol recommends dalteparin 200 IU /kg once daily as per Product Information) . The study intervention will be Rivaroxaban 15mg twice daily per oral for 3 weeks and then 20mg once daily thereafter. Rivaroxaban: oral tablet Duration of administration: 6 months monitor adherence: clinic review Cohort R1 refers to patients who are randomised to oral rivaroxaban or standard of care within 72 hours of diagnosis of venous thromboembolism. Cohort R2 refers the patients who are randomised to oral tablet rivaroxaban or standard of care at timepoint 30 days +/- 2 days of diagnosis of venous thromboembolism..