期刊
THROMBOSIS AND HAEMOSTASIS
卷 117, 期 11, 页码 2135-2145出版社
GEORG THIEME VERLAG KG
DOI: 10.1160/TH17-03-0171
关键词
anticoagulation; risk stratification; rivaroxaban; venous thromboembolism; neoplasms; prophylaxis
资金
- National Heart, Lung, and Blood Institute [1R34HL127156]
- Sondra and Stephen Hardis Chair in Oncology Research
- Cleveland Clinic Center of Excellence Grant
- Scott Hamilton CARES Initiative
- Janssen Research & Development, LLC
- Bayer Pharma AG
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.
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