Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial

Alok A. Khorana; Saroj Vadhan-Raj; Nicole M. Kuderer; Ted Wun; Howard Liebman; Gerald Soff; Chandra Belani; Eileen M. O'Reilly; Robert McBane; John Eikelboom; C.V Damaraju; Karen Beyers; Flavia Dietrich; Ajay K. Kakkar; Hanno Riess; Renata D'Alpino Peixoto; Gary H. Lyman

doi:10.1160/TH17-03-0171

Thrombosis and Haemostasis, Table of Contents

CC BY-NC-ND 4.0 · Thromb Haemost 2017; 117(11): 2135-2145
DOI: 10.1160/TH17-03-0171

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH Stuttgart

Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial

Alok A. Khorana

¹Cleveland Clinic, Cleveland, Ohio, United States

,

Saroj Vadhan-Raj

²The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

,

Nicole M. Kuderer

³University of Washington, Seattle, Washington, United States

,

Ted Wun

⁴University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

,

Howard Liebman

⁵University of Southern California Keck School of Medicine, Los Angeles, California, United States

,

Gerald Soff

⁶Memorial Sloan Kettering Cancer Center, New York, New York, United States

,

Chandra Belani

⁷Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States

,

Eileen M. O'Reilly

⁶Memorial Sloan Kettering Cancer Center, New York, New York, United States

,

Robert McBane

⁸Mayo Clinic, Rochester, Minnesota, United States

,

John Eikelboom

⁹McMaster University, Hamilton, Ontario, Canada

,

C.V Damaraju

¹⁰Janssen Research and Development, Raritan, New Jersey, United States

,

Karen Beyers

¹⁰Janssen Research and Development, Raritan, New Jersey, United States

,

Flavia Dietrich

¹⁰Janssen Research and Development, Raritan, New Jersey, United States

,

Ajay K. Kakkar

¹¹University College London and Thrombosis Research Institute, London, United Kingdom

,

Hanno Riess

¹²Charité University Hospitals, Berlin, Germany

,

Renata D'Alpino Peixoto

¹³Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada

,

Gary H. Lyman

¹⁴Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, United States

› Author Affiliations

Abstract

Venous thromboembolism (VTE) is a frequent complication of cancer associated with morbidity, mortality, increased hospitalizations and higher health care costs. Cancer patients at increased risk for VTE can be identified using a validated risk assessment score, and the incidence of VTE can be reduced in high-risk settings using anticoagulation. Rivaroxaban is a potent, oral, direct, factor Xa inhibitor approved for the prevention and treatment of thromboembolic events, including VTE. CASSINI is a double-blind, randomized, parallel-group, multicentre study comparing rivaroxaban with placebo in adult ambulatory patients with various cancers who are initiating systemic cancer therapy and are at high risk of VTE (Khorana score ≥ 2). Patients with primary brain tumours or those at risk for bleeding are excluded. Approximately 700 patients will be randomized 1:1 to rivaroxaban 10 mg daily or placebo for up to 6 months if there is no evidence of VTE from compression ultrasonography (CU) during screening or from routine care imaging within 30 days prior to randomization. Mandatory CU will also be performed at weeks 8 and 16 (±7 days), and at study end (±3 days). The primary efficacy hypothesis is that anticoagulation with rivaroxaban reduces the composite of objectively confirmed symptomatic or asymptomatic, lower-extremity, proximal deep-vein thrombosis (DVT); symptomatic, upper-extremity DVT; symptomatic or incidental pulmonary embolism; and VTE-related death compared with placebo. The primary safety objective is to assess major bleeding events (Clinical trial information: NCT02555878).

Keywords

anticoagulation - risk stratification - rivaroxaban - venous thromboembolism - neoplasms - prophylaxis

Full Text

References

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