Blood-Thinner Trial Halted Early Due to Efficacy


Janssen halted a trial of a cardiac drug early because it worked.

Janssen Research & Development today announced that it has halted a phase 3 trial of rivaroxaban (Xarelto) based on results showing it is effective in preventing adverse cardiac events. In a trial called COMPASS, the drug showed it could prevent heart attacks and strokes in patients with coronary artery disease or peripheral artery disease.

According to the company, Xarelto is the only non-vitamin K antagonist (NOAC) currently being evaluated in these high-risk patients.

The decision to halt the trial was based on a decision by the study’s data monitoring committee. That group concluded the trial had reached its primary endpoint of showing it could prevent these serious cardiovascular events.

A complete analysis of the data will be presented at an upcoming medical meeting which the company did not name.

The COMPASS trial is part of a larger clinical research program known as EXPLORER, which will enroll more than 275,000 people by its completion, the company said.

In COMPASS, patients were randomized to receive either Xarelto at 2.5 mg daily plus aspirin once a day or to get Xarelto 5 mg twice daily without aspirin. A third group got only aspirin. The aspirin dose in all three groups was 100 mg.

The potential market for the drug is huge. About 16.5 million Americans have coronary artery disease and 10 million have peripheral artery disease.

Xarelto reduces risk in patients with atrial fibrillation not caused by a heart valve problem.

The company noted that there is little information on how it compares with warfarin in patients who are currently on that blood-thinning drug.

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