Xarelto Study Stopped Early Due to Positive Results

Janssen recently announced that the phase 3 COMPASS study of Xarelto (rivaroxaban) was stopped early due to substantial safety and efficacy findings.

Xarelto was shown to prevent major adverse cardiac events, such as cardiovascular death, myocardial infarction, and stroke in patients with coronary artery disease or peripheral artery disease, according to a press release.

The study’s Data Monitoring Committee recommended the study stop earlier than planned after the results met the primary endpoint, which was prevention of major adverse cardiac events. The study was originally meant to end in March 2018, but was stopped more than 1 year early.

Due to the magnitude of the effect of Xarelto treatment in these patients, Janssen, Bayer, and the Population Health Research Institute, which collaborated on the trial, plan to offer the drug to patients in an open-label extension study, according to the release.

In the study, Xarelto was investigated in 27,402 patients with coronary artery disease or peripheral artery disease in more than 30 countries worldwide. Patients were randomized to receive Xarelto 2.5-mg per day plus aspirin 100-mg per day, Xarelto monotherapy 5-mg twice per day, or aspirin 100-mg once per day.

The clinical trial met its primary endpoint, which is why it was ended early. Janssen believes that this drug has the potential to address a clinical unmet need for patients with heart disease.

Janssen is planning to discuss additional data at upcoming conferences held in 2017.

Xarelto is the only non-vitamin K antagonist oral anticoagulant under assessment in this population who are at a high risk of fatal or debilitating myocardial infarction and stroke, Janssen reported.

Treatment with Xarelto may cause serious or fatal bleeding, especially in combination with aspirin, non-steroidal anti-inflammatory drugs, or heparin-containing medication. Patients may experience blood clots, headaches, pain, swelling, or dizziness.

The EXPLORER clinical research program for Xarelto includes 10 indication-seeking and label expansion studies beyond the 6 approved indications in the United States, according to the press release.

“Despite established and effective treatments, incidences of CAD and PAD are rising globally,” said Paul Burton, MD, PhD, FACC, vice president, Medical Affairs, Janssen. “We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the US Food and Drug Administration as quickly as possible.”