Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders

Major Studies

Xarelto® is the first oral, direct factor Xa inhibitor – a new generation of anticoagulants targeting the prevention and treatment of acute and chronic thromboembolic diseases. Xarelto is approved for stroke prevention in adults with non-valvular AF and one or more risk factors, for the treatment of DVT and prevention of recurrent DVT and PE in adults. It is also approved for the treatment of PE and prevention of recurrent DVT and PE in adults, for the prevention of VTE in adults undergoing elective hip or knee replacement and for secondary prevention after ACS in adults with elevated cardiac biomarkers and without prior stroke/TIA in combination with standard antiplatelet therapy.1

XANTUS Pooled

A Pooled Analysis of the Global XANTUS Programme

Real world, prospective, observational studies for stroke prevention in patients with atrial fibrillation

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EINSTEIN CHOICE

A Study of Flexible Dosage in Extended PE PE
Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
/DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
Treatment

Comparing the efficacy and safety of Xarelto 10 mg and 20 mg vs aspirin for the extended treatment of recurrent VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
beyond 12 months of anticoagulation therapy

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PIONEER

Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI with Stenting

An exploration of the use of Xarelto in NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
patients who undergo PCI with stenting

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REVISIT US

A Real World Database Study of Stroke Prevention in NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
Patients

A retrospective comparison of Xarelto vs warfarin

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XANTUS

First Published, Prospective, International, Observational Study of a NOAC in NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
Patients2

XANTUS evaluated major bleeding and stroke or systemic embolism in NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
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.

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US DoD PMSS

Retrospective Real-World NOAC Study

US DoD DoD
Department of Defense.
PMSS PMSS
Post-marketing safety surveillance.
is an ongoing 5-year pharmacovigilance study to evaluate major bleeding in 27,467 NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
patients taking Xarelto for stroke prevention in a real-world setting.

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XALIA

First Published, Prospective, International, Observational Study of a NOAC for the Treatment and Secondary Prevention of VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.

XALIA evaluated recurrent symptomatic venous thromboembolism and major bleeding in 5,142 acute DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
patients in real-world clinical settings.

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RELIEF

Real-Life Evidence of Stroke Prevention in Patients with Atrial Fibrillation

This study suggests Xarelto is associated with favourable effectiveness in NVAF NVAF
Non-valvular atrial fibrillation (= NVAF). The term NVAF is restricted to cases in which atrial fibrillation occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
patients without previous events compared to a VKA VKA
Vitamin K antagonist (= VKA). An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment are required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
when utilised in a real life setting3

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ATLAS ACS TIMI 51

ATLAS ACS ACS
Acute coronary syndrome (= ACS). An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of ACS include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
TIMI TIMI
Thrombolysis in Myocardial Infarction (= TIMI) bleeding criteria. This is a score used to determine the likelihood of ischaemic events or mortality in patients with unstable angina or non-ST segment elevation myocardial infarction (NSTEMI). There is also a separate TIMI risk score for patients with ST segment elevation myocardial infarction (STEMI).
51: a Phase III Study to Evaluate the Efficacy and Safety of Xarelto in the Secondary Prevention of ACS

The ATLAS ACS ACS
Acute coronary syndrome (= ACS). An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of ACS include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
TIMI TIMI
Thrombolysis in Myocardial Infarction (= TIMI) bleeding criteria. This is a score used to determine the likelihood of ischaemic events or mortality in patients with unstable angina or non-ST segment elevation myocardial infarction (NSTEMI). There is also a separate TIMI risk score for patients with ST segment elevation myocardial infarction (STEMI).
51 study is a global, phase III 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).

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ROCKET AF

ROCKET AF AF
Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
: Stroke Prevention in Atrial Fibrillation

ROCKET AF AF
Atrial fibrillation (= AF). A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
compared the efficacy and safety of once-daily rivaroxaban with warfarin for the prevention of stroke and systemic embolism in patients with non-valvular AF for whom guidelines recommend oral anticoagulation.

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EINSTEIN DVT/PE/EXT

EINSTEIN Programme: Treatment of Established VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.

The EINSTEIN clinical trial programme comprises three randomised phase III studies of rivaroxaban for the treatment of venous thromboembolism (VTE VTE
Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
) and the long-term prevention of recurrent VTE. It is the only clinical programme that has investigated a new oral anticoagulant anticoagulant
Anticoagulant drugs are used to treat and prevent blood clots. Sometimes referred to as ‘blood thinners’.
for the treatment of acute deep vein thrombosis thrombosis
Formation of a clot inside a blood vessel.
(DVT DVT
Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
) and treatment for acute pulmonary embolism (PE PE
Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
) in separate trials. The results of these pivotal trials were used to further assess the safety and efficacy of rivaroxaban in a prespecified pooled subgroup analysis.

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RECORD 1-4

RECORD Programme: 4 Completed Phase III Studies on Total Knee and Total Hip Replacement Surgery

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).

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