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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
1   Cleveland Clinic, Cleveland, Ohio, United States
,
Saroj Vadhan-Raj
2   The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
,
Nicole M. Kuderer
3   University of Washington, Seattle, Washington, United States
,
Ted Wun
4   University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
,
Howard Liebman
5   University of Southern California Keck School of Medicine, Los Angeles, California, United States
,
Gerald Soff
6   Memorial Sloan Kettering Cancer Center, New York, New York, United States
,
Chandra Belani
7   Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
,
Eileen M. O'Reilly
6   Memorial Sloan Kettering Cancer Center, New York, New York, United States
,
Robert McBane
8   Mayo Clinic, Rochester, Minnesota, United States
,
John Eikelboom
9   McMaster University, Hamilton, Ontario, Canada
,
C.V Damaraju
10   Janssen Research and Development, Raritan, New Jersey, United States
,
Karen Beyers
10   Janssen Research and Development, Raritan, New Jersey, United States
,
Flavia Dietrich
10   Janssen Research and Development, Raritan, New Jersey, United States
,
Ajay K. Kakkar
11   University College London and Thrombosis Research Institute, London, United Kingdom
,
Hanno Riess
12   Charité University Hospitals, Berlin, Germany
,
Renata D'Alpino Peixoto
13   Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada
,
Gary H. Lyman
14   Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, United States
› Author Affiliations
Further Information

Publication History

10 March 2017

01 July 2017

Publication Date:
30 November 2017 (online)

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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
 

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