© 2016, Bayer AS
Siste oppdatering 08 april 2016
L.NO.MKT.03.2016.1478

Clinical Studies- Targeting Acute and Chronic Thromboembolic Disorders

Xarelto® (approved for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery) is the first oral, direct Factor Xa inhibitor- a new generation of anticoagulants targeting the prevention and treatment of acute and chronic thromboembolic diseases.1, 9 Xarelto® is not yet approved for the other indications mentioned below.

RECORD programme: 4 completed phase III studies on total knee and total hip replacement surgery

RECORD is an extensive clinical development programme involving more than 12,500 patients in 39 countries. Superior efficacy and similar safety of one-tablet, once-daily Xarelto® were demonstrated in head-to-head comparisons with enoxaparin when both drugs were given over the same time period (RECORD1 over 5 weeks, RECORD3 and RECORD4 over 2 weeks) and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2) in the prevention of venous thromboembolism (VTE) following total hip and total knee replacement surgery.2, 3, 4, 9

MAGELLAN: medically ill patients

MAGELLAN is an ongoing phase III multinational study comparing the efficacy and safety of one-tablet, once-daily Xarelto® with subcutaneous enoxaparin once daily in over 8,000 patients hospitalised for medical illnesses who are at risk for thromboembolic disorders.16

EINSTEIN programme: treatment of established VTE

More than 7,500 patients with established symptomatic VTE will be enrolled in the 3 ongoing phase III EINSTEIN studies to determine the efficacy and safety of oral Xarelto® in the treatment and secondary prevention of VTE compared with body weight–adjusted subcutaneous enoxaparin in combination with a vitamin K antagonist.17, 18, 19

ROCKET: stroke prevention in atrial fibrillation

In the ongoing phase III ROCKET study the efficacy and safety of one-tablet, once-daily Xarelto® for the prevention of stroke will be evaluated against dose-adjusted warfarin in 14,000 patients with atrial fibrillation.15

ATLAS ACS TIMI 51: a phase lIl study to evaluate the efficacy and safety of Xarelto® in the secondary prevention of ACS

The ATLAS ACS TIMI 51 study is a global, phase III clinical study designed to evaluate the safety and efficacy of Xarelto® in addition to standard therapy. The ATLAS study programme is planned to enroll up to 19,500 patients. 66
  • 1 - Xarelto® (rivaroxaban) Summary of Product Characteristics as approved by the European Commission.
  • 9 - International Congress on Thrombosis: Rivaroxaban is first novel oral anticoagulant to significantly reduce the composite outcome of symptomatic VTE and death [press release]. Leverkusen, Germany: Bayer HealthCare AG; June 30, 2008.
  • 2 - Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  • 3 - Kakkar AK, Brenner B, Dahl OE, et al; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  • 4 - Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
  • 16 - MAGELLAN - Multicenter, rAndomized, Parallel Group Efficacy and Safety for the Prevention of VTE in Hospitalized Medically iLL Patients Comparing rivaroxabAN With Enoxaparin. Available at: http://clinicaltrials.gov/ct2/show/NCT00571649. Accessed 13 August 2008.
  • 17 - Once-Daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study. Available at http://clinicaltrials.gov/ct2/show/NCT00439725. Accessed 13 August 2008.
  • 18 - Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis Without Symptomatic Pulmonary Embolism: Einstein-DVT Evaluation. Available at http://clinicaltrials.gov/ct2/show/NCT00440193. Accessed 13 August 2008.
  • 19 - Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism With Or Without Symptomatic Deep-Vein Thrombosis: Einstein-PE Evaluation. Available at http://clinicaltrials.gov/ct2/show/NCT00439777. Accessed 13 August 2008.
  • 15 - A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation. Available at http://clinicaltrials.gov/ct2/show/NCT00403767. Accessed 13 August 2008.
  • 66 - American Heart Association: Bayer’s Xarelto® Shows Encouraging results in Patients with Acute Coronary Syndrome [press release]. Leverkusen, Germany: Bayer HealthCare AG; November 10, 2008
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.
Venous thromboembolism
A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
Efficacy
The ability of a drug to produce the desired effect.
Subcutaneous
Introduced beneath the skin.
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.
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).

Quick Polls

Ongoing clinical studies with Xarelto® are being conducted in a number of acute and chronic thromboembolic disorders. Which do you consider to be the most significant clinical unmet need?

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