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

Research output: Contribution to journalArticle

20 Citations (Scopus)

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).

Original languageEnglish (US)
Pages (from-to)2135-2145
Number of pages11
JournalThrombosis and Haemostasis
Volume117
Issue number11
DOIs
StatePublished - Jan 1 2017

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Venous Thromboembolism
Neoplasms
Placebos
Ultrasonography
Upper Extremity Deep Vein Thrombosis
Random Allocation
Rivaroxaban
Pulmonary Embolism
Brain Neoplasms
Venous Thrombosis
Health Care Costs
Multicenter Studies
Lower Extremity
Hospitalization
Clinical Trials
Hemorrhage
Morbidity
Safety
Mortality
Incidence

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Khorana, Alok A. ; Vadhan-Raj, Saroj ; Kuderer, Nicole M. ; Wun, Ted ; Liebman, Howard ; Soff, Gerald ; Belani, Chandra ; O'Reilly, Eileen M. ; McBane, Robert ; Eikelboom, John ; Damaraju, C. V. ; Beyers, Karen ; Dietrich, Flavia ; Kakkar, Ajay K. ; Riess, Hanno ; Peixoto, Renata D.Alpino ; Lyman, Gary H. / Rivaroxaban for preventing venous thromboembolism in high-risk ambulatory patients with cancer : Rationale and design of the CASSINI trial. In: Thrombosis and Haemostasis. 2017 ; Vol. 117, No. 11. pp. 2135-2145.
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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 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).",
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Khorana, AA, Vadhan-Raj, S, Kuderer, NM, Wun, T, Liebman, H, Soff, G, Belani, C, O'Reilly, EM, McBane, R, Eikelboom, J, Damaraju, CV, Beyers, K, Dietrich, F, Kakkar, AK, Riess, H, Peixoto, RDA & Lyman, GH 2017, 'Rivaroxaban for preventing venous thromboembolism in high-risk ambulatory patients with cancer: Rationale and design of the CASSINI trial', Thrombosis and Haemostasis, vol. 117, no. 11, pp. 2135-2145. https://doi.org/10.1160/TH17-03-0171

Rivaroxaban for preventing venous thromboembolism in high-risk ambulatory patients with cancer : Rationale and design of the CASSINI trial. / Khorana, Alok A.; Vadhan-Raj, Saroj; Kuderer, Nicole M.; Wun, Ted; Liebman, Howard; Soff, Gerald; Belani, Chandra; O'Reilly, Eileen M.; McBane, Robert; Eikelboom, John; Damaraju, C. V.; Beyers, Karen; Dietrich, Flavia; Kakkar, Ajay K.; Riess, Hanno; Peixoto, Renata D.Alpino; Lyman, Gary H.

In: Thrombosis and Haemostasis, Vol. 117, No. 11, 01.01.2017, p. 2135-2145.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rivaroxaban for preventing venous thromboembolism in high-risk ambulatory patients with cancer

T2 - Rationale and design of the CASSINI trial

AU - Khorana, Alok A.

AU - Vadhan-Raj, Saroj

AU - Kuderer, Nicole M.

AU - Wun, Ted

AU - Liebman, Howard

AU - Soff, Gerald

AU - Belani, Chandra

AU - O'Reilly, Eileen M.

AU - McBane, Robert

AU - Eikelboom, John

AU - Damaraju, C. V.

AU - Beyers, Karen

AU - Dietrich, Flavia

AU - Kakkar, Ajay K.

AU - Riess, Hanno

AU - Peixoto, Renata D.Alpino

AU - Lyman, Gary H.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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).

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