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 the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, for the treatment of deep vein thrombosis (DVT) and the prevention of recurrent venous thromboembolism (VTE) following and acute DVT in adults. It is also approved for the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery.
Clinical Studies- Targeting Acute and Chronic Thromboembolic Disorders
EINSTEIN programme: treatment of established VTE
The EINSTEIN clinical trial programme comprises three randomized phase III 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.
RECORD programme: 4 completed phase III studies on total knee and total hip replacement surgery
The RECORD programme comprised four randomized clinical trials of rivaroxaban for the prevention of venous thromboembolism in adult patients after total hip replacement (THR) or total knee replacement (TKR).
MAGELLAN: medically ill patients
MAGELLAN investigated the efficacy and safety of oral rivaroxaban compared with standard-duration subcutaneous enoxaparin and evaluated the role of extended-duration thromboprophylaxis in hospitalized acutely ill patients at risk of VTE and for whom guidelines typically recommend thromboprophylaxis.
- 66 - A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome. Available at http://clinicaltrials.gov/ct2/show/NCT00809965. Accessed 2 November 2010
- Atrial fibrillation
- 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.
- Factor Xa
- Pivotal component of blood clotting cascade. Stimulates the production of thrombin, the enzyme in the coagulation cascade that promotes the formation of blood clots.
- Thrombosis
- Formation of a clot inside a blood vessel.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Deep vein thrombosis
- 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.
- Efficacy
- The ability of a drug to produce the desired effect.
- Acute coronary syndrome
- An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome 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).
- Subcutaneous
- Introduced beneath the skin.
- Thromboprophylaxis
- Preventative treatment for blood clotting.
