Phase 3
Completed N=841
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
Source: ClinicalTrials.gov NCT02555878 ↗Enrolled (actual)
841
Serious AEs
32.4%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) — 8.79; 5.95; 1.90; 2.14 Percentage of participants — p== 0.101
◆ Published Evidence
Highly cited
715citations · ~102 / year
Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer.
Summary
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
Linked Publications (5)
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Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer.
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Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial. Rationale and Design of the CASSINI Trial.
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Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy.
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Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study.
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Biomarker signatures in cancer patients with and without venous thromboembolism events: a substudy of CASSINI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) |
8.79; 5.95; 1.90; 2.14; 1.19; 0.48 | = 0.101 |
| PRIMARY Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) |
0.99; 1.98 | = 0.265 |
| SECONDARY Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths |
5.23; 3.81 | — |
| SECONDARY Percentage of Participants With All-Cause Mortality |
23.8; 20.0 | — |
| SECONDARY Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE) |
1.66; 0.95 | — |
| SECONDARY Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE |
0.48; 0.24 | — |
| SECONDARY Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1 |
29.5; 23.1 | — |
| SECONDARY Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2 |
5.23; 3.81 | — |
| SECONDARY Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3 |
10.7; 6.90 | — |
| SECONDARY Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4 |
6.89; 5.71 | — |
| SECONDARY Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding |
1.98; 2.72 | — |
| SECONDARY Percentage of Participants With Time to the First Occurrence of Minor Bleeding |
3.96; 6.91 | — |
| SECONDARY Percentage of Participants With Time to the First Occurrence of Any Bleeding |
6.44; 11.1 | — |
Eligibility Criteria
Inclusion Criteria
- Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
- Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
- Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care
Exclusion Criteria
- Diagnosis of primary brain tumors
- Known history of brain metastases
- Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
- Hematologic malignancies with the exception of lymphoma
- Platelet count less than (<) 50, 000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months
Data sourced from ClinicalTrials.gov (NCT02555878) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.