Clinical Trials

Date: 2011-04-05

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the 60th American College of Cardiology (ACC) Annual Scientific Session.

Company: Bayer Healthcare (Germany)

Product: Xarelto® (rivaroxaban)

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Disease:

prevention of venous thromboembolism (VTE) in hospitalized patients with acute medical illness

Therapeutic area: Cardiovascular diseases

Country: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croati, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hngary, India, Indonesia, Israel, Italy, Japan, Republic of Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Pakistan, Peru, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, UK, USA

Trial details:

• MAGELLAN was a multi-national, randomized, double-blind, placebo-controlled Phase III study investigating rivaroxaban for the prevention of VTE in patients admitted to hospital with an acute medical illness. It evaluated 8,101 acutely ill medical patients from 52 countries, with a decreased level of mobility including at least one day of complete immobilization during hospitalization. MAGELLAN was designed to demonstrate the superior efficacy of a 35 ± 4 day treatment period with oral rivaroxaban (10 mg once daily) for VTE prophylaxis, compared to a 10 ± 4 day treatment period with subcutaneous enoxaparin (40 mg once daily) followed by placebo in men and women >40 years of age. Further, the study evaluated the non-inferiority of oral rivaroxaban for VTE prophylaxis compared to standard of care enoxaparin in this patient population at 10 ± 4 days. (NCT00571649)

Latest news:

• Bayer announced that findings from the MAGELLAN Phase III clinical study evaluating rivaroxaban for the prevention of venous thromboembolism (VTE) in hospitalized patients with acute medical illness were presented at the 60th American College of Cardiology (ACC) Annual Scientific Session. In the study, rivaroxaban met its primary efficacy endpoints of demonstrating non-inferiority to enoxaparin in short-term use (10 ± 4 days) and superiority to enoxaparin (10 ± 4 days) followed by placebo in long-term use (35 ± 4 days) in the prevention of VTE in hospitalized patients with acute medical illness. The rates of major plus non-major clinically relevant bleeding, the study’s principal safety outcome, were low in both arms of the study, with unexpectedly lower rates observed in the enoxaparin arm compared to patients receiving rivaroxaban.
• In the MAGELLAN study, results for the primary efficacy endpoints (a composite of asymptomatic proximal DVT detected by ultrasonography, symptomatic DVT, non-fatal pulmonary embolism (PE), and VTE-related death) in the pre-specified study durations were as follows:
• - In the short-term (10 ± 4 days) evaluation, rivaroxaban achieved non-inferiority compared to enoxaparin [2.7% vs. 2.7%, p=0.0025] in the per-protocol population.
• - Evaluated in the extended period (35 ± 4 days), rivaroxaban was superior to short-term enoxaparin (10 ± 4 days) followed by placebo, in the modified intent-to-treat (MITT) population [4.4% vs. 5.7%, respectively, RR 0.77, p=0.0211]. In the prevention of VTE in Acutely ill Patients, rivaroxaban compares favorably with enoxaparin but does not show a consistent net clinical benefit
• MAGELLAN study meets primary efficacy endpoints of demonstrating non-inferiority in short-term use and superiority in long-term use. Primary analysis shows no consistent positive benefit-risk balance across heterogeneous patient population studied.
• The principal safety outcome was the incidence of treatment-emergent major bleeding events and non-major, clinically relevant bleeding events observed no later than two days after the last intake of the double-blind study drug. The rates of primary safety events were low overall in both arms of the study, but there was a statistically significant increase in patients randomized to rivaroxaban compared with patients in the enoxaparin arm on Day 10 (2.8% vs. 1.2%, respectively; p<0.0001) and on Day 35 (4.1% vs. 1.7%, respectively; p<0.0001). Rates of other adverse events, including liver and cardiovascular, were similar across both study arms and rates for rivaroxaban were in line with previous trial data.

Is general: Yes