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CASSINI: Rivaroxaban for VTE Prophylaxis in Cancer
NCT02555878Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2015
- Primary completion
- Aug 2018
- Countries
- 10
- Sponsor
- Janssen Pharmaceutical
- Modality
- Small Molecules
- Drugs
- rivaroxaban
- Conditions
- venous thromboembolism (VTE)
01
Overview
Phase 3, randomised, double-blind trial in venous thromboembolism (VTE) comparing Rivaroxaban with Placebo (2 arms). Primary endpoints: Time to First Occurrence of Primary Efficacy Endpoint (Composite of symptomatic/asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT,… at Day 180 and Time to the First Occurrence of Major Bleeding Events up to 32 weeks. Started Sep 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Rivaroxaban
Rivaroxaban 10 mg orally once daily
Placebo
Matching placebo orally once daily
03
Who it enrols
Ambulatory adult participants with histologically confirmed solid malignancy or lymphoma, initiating systemic cancer therapy, and at high risk for VTE (Khorana score >= 2). Excludes primary brain tumors and known brain metastases.
04
Endpoints
Primary
Time to First Occurrence of Primary Efficacy Endpoint (Composite of symptomatic/asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT,…
Time to the First Occurrence of Major Bleeding Events
Secondary
Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths
All-Cause Mortality
Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)
Time to the First Occurrence of Fatal or Non-fatal Visceral VTE
Time to the First Occurrence of Clinically Relevant Non-major Bleeding
05
Results
Not all primary endpoints met
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