Janssen’s Phase III trial of rivaroxaban for embolic stroke stopped early

6th October 2017 (Last Updated October 6th, 2017 00:00)

Janssen Research & Development and its development partner Bayer have stopped the Phase III NAVIGATE ESUS clinical trial of Xarelto (rivaroxaban) assessed as a secondary prevention for stroke and systemic embolism in patients who experienced a recent embolic stroke of undetermined source (ESUS).

Janssen Research & Development and its development partner Bayer have stopped the Phase III NAVIGATE ESUS clinical trial of Xarelto (rivaroxaban) assessed as a secondary prevention for stroke and systemic embolism in patients who experienced a recent embolic stroke of undetermined source (ESUS).

During the trial, efficacy was found to be comparable between rivaroxaban and aspirin, while the bleeding rates were low and within the expected range.

However, increased bleeding was observed in the rivaroxaban group, when compared to aspirin.

The trial has been stopped early based on the recommendation by its Independent Data Monitoring Committee (IDMC) that rivaroxaban is unlikely to show overall benefit over the standard of care, aspirin, even if the trial were to be completed.

Xarelto is a prescription medicine used to minimise the risk of stroke and blood clots in atrial fibrillation patients whose condition is not caused by a heart valve problem.

"Results from ROCKET AF and emerging real-world data continue to show the positive benefit of Xarelto in preventing cardiovascular events, including stroke."

The medicine is also used to treat deep vein thrombosis and pulmonary embolism, and to decrease the risk of blood clot formation in legs and lungs after recent knee or hip replacement surgery.

Janssen Research & Development medical affairs vice-president Paul Burton said: “Xarelto is a highly effective anticoagulant for patients at risk of stroke from atrial fibrillation, as well as for the prevention and treatment of clots in a variety of approved indications.

“Results from ROCKET AF and emerging real-world data continue to show the positive benefit of Xarelto in preventing cardiovascular events, including stroke.”

The Phase III NAVIGATE ESUS trial compared once-a-day 15mg of rivaroxaban with 100mg of aspirin in around 7,200 subjects at 459 centres in 31 countries.

The primary efficacy endpoint of the trial was a composite of stroke and systemic embolism, while the primary safety endpoint was major bleeding.