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Janssen Expands EXPLORER Global Cardiovascular Research Program to Evaluate the Role of

29, 2014 /PRNewswire/ Research Development, LLC (Janssen) and its development partner, Bayer HealthCare,patagonia discount code hertz3 announced today the expansion of the EXPLORER global cardiovascular research program for XARELTO (rivaroxaban) to include additional high risk patient populations. New trials will investigate rivaroxaban, the most studied Factor Xa inhibitor, for the treatment of acute coronary syndrome (ACS), embolic stroke of undetermined patagonia discount code hertz0source (ESUS) and peripheral artery disease (PAD). this research is successful, Janssen may seek FDA approval of XARELTO for these indications. These new studies will help us to uncover the full ppatagonia outlet onlineotential of this medicine in making a difference for patients with critical medical needs.

GEMINI 1 2 ACS, a global indication seeking clinical program, designed to evaluate rivaroxaban in patients who suffer from acute coronary syndrome (ACS). The program will launch with 1 ACS, to investigate the benefits of the dual pathway strategy of anticoagulation with rivaroxaban in combination with a single antiplatelet agent for long term secondary prevention of additional cardiovascular events in patients with ACS. The study will include 2,000 to 3,000 patients in more than 10 countries. If successful, the Phase 2 study will be followed by GEMINI 2 ACS, a global Phase 3 study. The GEMINI ACS program builds off the global 19,000 patient ATLAS ACS 2 TIMI 51 trial, which showed treatment with XARELTO resulted in reductions in important cardiovapatagonia discount code hertz1scular events. ACS is a complication of coronary heart disease which is the leading cause of death in the United States. ACS is typically associated with the disruption of an atherosclerotic plaque and subsequent formation of a blood clot that can cause a sudden reduction in blood flow to the heart. Reduced blood flow to the heart can result in a heart attack or unstable angina, a condition signifying that a heart attack may soon occur. Each year more than 1.1 million Americans are discharged from the hospital with a primary or secondary diagnosis of ACS.

NAVIGATE ESUS, a global Phase 3 indication seeking study, designed to evaluate rivaroxaban in patients with embolic stroke of undetermined source (ESUS). The study will include at least 7,000 patients in than cbest fly fishing in patagoniaountries. Each year, more than 690,000 people in the United States are estimated to suffer an ischemic stroke, a condition where the blood flow to the brain is blocked by a clot. In approximately 25 percent of these patients, the embolic source causing the stroke is unknown, and there is limited knowledge available to guide treatment decisions for these patients.

VOYAGER PAD, a global Phase 3 indication seeking study, designed to evaluate rivaroxaban in patients with peripheral artery disease (PAD) undergoing peripheral artery interventions. The study will include at least 5,000 patients in more than 20 countries. is estimated to affect more than eight million Americans age 40 and above, with prevalence increasing with age. PAD occurs when the build up of plaque, or atherosclerosis, narrows or blocks vessels that transport blood from the heart to the limbs. Patients with PAD are at increased risk of heart attack and stroke.

About the EXPLORER Global Cardiovascular Research Program EXPLORER is an integral part of the extensive clinical development program for rivaroxaban, evaluating its use in a broad range of cardiovascular conditions. The global clinical development program for rivaroxaban, including EXPLORER, encompasses 17 Phase 3 clinical trials, 10 of which are completed. By the time of its completion, more than 275,000 patients will have participated in the rivaroxaban clinical development program, including completed and ongoing clinical trials, independent registries and non interventional studies. More than 151,000 of those patients have been or will be part of controlled, randomized clinical trials.

Additional studies within thpatagonia discount code hertz2e EXPLORER program include:

X VeRT, first prospective exploratory trial comparing the efficacy and safety of a Factor Xa inhibitor, rivaroxaban, once daily, to dose adjusted vitamin K antagonist (VKA) treatment, such as warfarin, in patients with non valvular atrial fibrillation (NVAF) undergoing cardioversion. Cardioversion is a common medical procedure that converts an abnormally fast heart rate to a normal rhythm using electricity or antiarrhythmic medications. The findings of the X VeRT trial will be presented in a Hot Line Session at ESC Congress 2014 in Barcelona, Spain, on September 2, 2014.

EINSTEIN CHOICpatagonia better sweater green womenE, an ongoing study of long term reduction in the risk of recurrent deep vein thrombosis (DVT) or pulmonary embolism (PE) comparing standard dose rivaroxaban and reduced dose rivaroxaban to aspirin.

EINSTEIN JUNIOR, ongoing study rivaroxaban for the treatment and secondary prevention of DVT and/or PE in pediatric populations.

MARINER, ongoing study examining rivaroxaban in reducing the risk of recurrent DVT and PE in acutely medically ill patients post hospital discharge.

patagonia discount code hertzCOMMANDER HF, an ongoing study examining rivaroxaban in reducing the risk of major adverse cardiac eventspatagonia discount code little tikes (MACE) in patients with chronic heart failure and significant coronary apatagonia discount code one stoprtery disease.

COMPASS, an ongoing study examining rivaroxaban in reducing the risk of MACE in patients with coronary or peripheral artery disease.

VENTURE AF, on ongoing study of the safety of rivaroxaban and vitamin K antagonist (VKA) in patients with NVAF undergoing catheter ablation. XARELTO is broadly reimbursed with 96 percent of patients on Medicare Part D and 92 percent of commercial patients covered at the lowest branded co pay. XARELTO has a broad indication profile and is approved for six indications:

To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO and warfarin compare in reducing the risk of stroke.

To treat patients with deep vein thrombosis (DVT).

To treat patients with pulmonary embolism (PE).

To reduce the risk of recurrence of DVT or PE following an initial six month treatment for acute venous thromboembolism.

To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.

To reduce the risk patagonia everlong review 7zipof blood clots in the legs and lungs of patients who have just had hip replacement surgery.

WHAT IS XARELTO XARELTO is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO and warfarin compare in reducing the risk of stroke.

XARELTO is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.

XARELTO is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

For people taking XARELTO for atrial fibrillation: People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to patagonia guide pants hemthe brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO you may have increased risk of forming apatagonia guide pants urban clot in your blood. Do not stop takipatagonia guide pants xcvrng XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

XARELTO can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO is a blood thinner medicine that reduces blood clotting. While you take XARELTO you are likely to bruise more easily and it may take longer for bleeding to stop.

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