Clinical Studies – Targeting Acute and Chronic
Thromboembolic Disorders
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Major Studies
Xarelto® was the first oral, direct factor Xa inhibitor – a generation of anticoagulants targeting the prevention and treatment of acute and chronic thromboembolic diseases. Xarelto is approved for stroke prevention in adults with NVAF and one or more risk factors, for the treatment of DVT and prevention of recurrent DVT and PE in adults, for the prevention of atherothrombotic events in adults with CAD/PAD at high risk of ischaemic events in combination with acetylsalicylic acid (ASA). It is also approved for the
treatment of PE and prevention of recurrent DVT and PE in adults, the prevention of VTE in adults undergoing elective hip or knee replacement, the treatment of VTE and prevention of recurrence in children <18 years old after at least 5 days of initial parenteral anticoagulation and for secondary prevention after ACS in adults with elevated cardiac biomarkers and without prior stroke/TIA in combination with (ASA) alone or with ASA plus clopidogrel or ticlopidine.
A Pooled Analysis of the Global XANTUS Programme
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Real world, prospective, observational studies for stroke prevention in patients with atrial fibrillation.
A Study of Flexible Dosage in Extended PE/DVT Treatment
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Comparing the efficacy and safety of Xarelto 10 mg and 20 mg vs aspirin for the extended treatment of recurrent VTE beyond 12 months of anticoagulation therapy.
Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI with Stenting
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An exploration of the use of Xarelto in NVAF patients who undergo PCI with stenting
Prospective, International, Observational Study of a NOAC in NVAF Patients
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XANTUS evaluated major bleeding and stroke or systemic embolism in NVAF patients in real-world clinical settings, ranging from primary care practices to cardiologists’ offices and hospitals. More than 6,500 NVAF patients were treated with Xarelto.
Prospective, International, Observational Study of a NOAC for the Treatment and Secondary Prevention of VTE
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XALIA evaluated recurrent symptomatic venous thromboembolism and major bleeding in 5142 acute DVT patients in real-world clinical settings.
ATLAS ACS TIMI 51: a Phase 3 Study to Evaluate the Efficacy and Safety of Xarelto in the Secondary Prevention of ACS
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The ATLAS ACS TIMI 51 study is a global, Phase 3 clinical study designed to evaluate the safety and efficacy of Xarelto in addition to standard therapy (acetylsalicylic acid alone or acetylsalicylic acid plus clopidogrel or ticlopidine).
ROCKET AF: Stroke Prevention in Atrial Fibrillation
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ROCKET AF compared the efficacy and safety of once-daily rivaroxaban with warfarin for the prevention of stroke and systemic embolism in patients with NVAF for whom guidelines recommend oral anticoagulation.
EINSTEIN Programme: Treatment of Established VTE
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The EINSTEIN clinical trial programme comprises four randomised Phase 3 studies of rivaroxaban for the treatment of venous thromboembolism (VTE) and the long-term prevention of recurrent VTE. It is the only clinical programme that has investigated a new oral anticoagulant for the treatment of acute deep vein thrombosis (DVT) and treatment for acute pulmonary embolism (PE) in separate trials. It also includes the first completed trial of an oral anticoagulant in children, the largest study to date in children with VTE. The results of these pivotal trials were used to further assess the safety profile and efficacy of Xarelto in a pooled subgroup analysis.
RECORD Programme: 4 Phase III Studies on Total Knee and Total Hip Replacement Surgery
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The RECORD programme comprised four randomised clinical trials of rivaroxaban for the prevention of venous thromboembolism in adult patients after elective total hip replacement (THR) or elective total knee replacement (TKR).
COMPASS: A randomised trial involving patients with chronic atherosclerotic vascular disease
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The COMPASS trial compared whether rivaroxaban in combination with aspirin or given alone is more effective than aspirin alone in preventing major cardiovascular events in patients with chronic atherosclerotic vascular disease.
HoT-PE: Early discharge and home treatment of patients with low-risk Pe with Xarelto
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A prospective, multicentre, single-arm trial to investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE with Xarelto
SELECT-D: A randomised control trial of Xarelto vs dalteparin for the treatment of VTE in patients with active cancer
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A multicentre, randomised, open label pilot trial in patients with active cancer to assess the prevention of recurrent VTE
SELECT-D extension: Treatment of cancer-associated VTE: 12 month outcomes of placebo vs Xarelto randomisation of the SELECT-D trial.
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A phase 3, randomised, double-blind study to investigate VTE recurrence and bleeding with Xarelto or placebo in extended treatment after 6 months
COSIMO: Patients with active cancer and VTE changing to Xarelto for prevention of recurrent VTE
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A prospective, non-interventional, single-arm cohort to investigate real-world treatment satisfaction and quality of life with Xarelto
PP-XAR-ALL-1814-2