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Siste oppdatering 08 april 2016
L.NO.MKT.03.2016.1478

Medically Ill: MAGELLAN

MAGELLAN: Xarelto® versus enoxaparin in hospitalised acute medically ill patients

MAGELLAN is a study comparing Xarelto® with enoxaparin for the prevention of venous thromboembolism (VTE) in patients hospitalised for acute medical illnesses.16

Objectives and endpoints

The objective of MAGELLAN is to compare the efficacy of one 10 mg tablet of Xarelto® once daily administered for 35±4 days in VTE prophylaxis to the efficacy of 40 mg subcutaneous once-daily enoxaparin administered for 10±4 days in patients who have been hospitalised for medical illnesses (eg, heart failure, cancer, stroke).
The primary efficacy endpoint is defined as a composite endpoint of asymptomatic proximal deep vein thrombosis (DVT) detected by bilateral ultrasound, symptomatic DVT, non-fatal pulmonary embolism (PE), and VTE-related death.
The safety endpoints are major bleeding and clinically relevant non-major bleeding.16

Study design

MAGELLAN is a randomised, double-blind, placebo-controlled study in about 8,000 hospitalised medically ill patients at risk for VTE. The enrolled patients are being randomly assigned to one of the following regimens:
  • Xarelto® 10 mg tablet once daily plus subcutaneous once-daily placebo
  • Subcutaneous enoxaparin 40 mg once daily plus oral placebo once daily
Xarelto® and the oral placebo are given for 35 days. Enoxaparin and the subcutaneous placebo are administered for 10 days. The patients return for a follow-up visit 55 days after the last dose of Xarelto® or oral placebo.16



 

  • 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.
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.
Composite endpoint
A combination of two or more endpoints in a clinical trial.
Thrombosis
Formation of a clot inside a blood vessel.
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.

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VTE causes over 500,000 deaths in Europe every year. 46

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