Rivaroxaban for preventing venous thromboembolism in high-risk ambulatory patients with cancer: Rationale and design of the CASSINI trial Journal Article
| Authors: | Khorana, A. A.; Vadhan-Raj, S.; Kuderer, N. M.; Wun, T.; Liebman, H.; Soff, G.; Belani, C.; O'Reilly, E. M.; McBane, R.; Eikelboom, J.; Damaraju, C. V.; Beyers, K.; Dietrich, F.; Kakkar, A. K.; Riess, H.; D'Alpino Peixoto, R.; Lyman, G. H. |
| Article Title: | Rivaroxaban for preventing venous thromboembolism in high-risk ambulatory patients with cancer: Rationale and design of the CASSINI trial |
| 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 withvarious cancers who are initiatingsystemiccancer therapy andare at high risk of VTE (Khorana score ≥ 2). Patients with primary brain tumours or those at risk forbleedingareexcluded.Approximately700patientswillberandomized1:1torivaroxaban 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 reducesthe composite ofobjectivelyconfirmed 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). © 2017 IOP Publishing Ltd. |
| Keywords: | adult; controlled study; major clinical study; mortality; placebo; drug efficacy; drug safety; brain tumor; follow up; neoplasms; cancer prevention; computer assisted tomography; randomized controlled trial; anticoagulant therapy; deep vein thrombosis; cancer therapy; risk assessment; lung embolism; health care cost; hospitalization; screening; multicenter study; prophylaxis; echography; risk stratification; ambulatory care; thrombocyte count; imaging; anticoagulation; double blind procedure; creatinine clearance; partial thromboplastin time; sample size; venous thromboembolism; rivaroxaban; hemostasis; knee replacement; invasive procedure; blood clotting factor 10a inhibitor; upper limb; arterial thromboembolism; human; male; female; priority journal; article; malignant neoplasm |
| Journal Title: | Thrombosis and Haemostasis |
| Volume: | 117 |
| Issue: | 11 |
| ISSN: | 0340-6245 |
| Publisher: | Schattauer Publishers, Stuttgart |
| Date Published: | 2017-11-01 |
| Start Page: | 2135 |
| End Page: | 2145 |
| Language: | English |
| DOI: | 10.1160/th17-03-0171 |
| PROVIDER: | scopus |
| PUBMED: | 28933799 |
| PMCID: | PMC6328370 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 January 2018 -- Source: Scopus |
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