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Janssen Pharmaceutical, Premier collaborate on atrial fibrillation study

Wednesday, April 5, 2017

Janssen Pharmaceuticals is collaborating with Premier on the first and largest study of its kind to address an unmet medical need for hospitalized patients with atrial fibrillation (AF) who are at risk for ischemic stroke. Named QUANTUM AF (Quantify Use of ANTicoagUlation to improve Management of AF), the study will evaluate the effect of a structured hospital quality improvement (QI) program on oral anticoagulant (OAC) use in these patients.

Nearly six million Americans are diagnosed with AF, an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. It is the most common serious heart rhythm abnormality in people over the age of 65. When a clot forms in the heart due to AF, it can travel to the brain and cause a stroke. Since one in three people with AF will have a stroke at some point in their life, most recent guidelines recommend using OAC therapy, which has been proven to reduce the risk of stroke by 60%.4 However, according to a recent study, only half of AF patients at risk for stroke are treated with an OAC at discharge.

“The enormous number of people with AF who leave the hospital without medication, and therefore are at risk for stroke, represents a tremendous unmet medical need,” said Paul Burton, M.D., Ph.D., FACC, vice president, Medical Affairs, Janssen. “We’re thrilled to collaborate with Premier on the QUANTUM AF initiative in an effort to understand this significant need and help ensure patients are appropriately protected against a stroke when they leave the hospital.”

This prospective, parallel-group, cluster-randomized study will involve approximately 150 hospitals which researchers will assign in a 1:1 ratio either to the QI program arm or to the Usual Care arm. The study will determine whether the implementation of a QI program, including educational and process-based interventions, compared with standard hospital practice, will result in a greater proportion of patients with AF appropriately treated with an OAC. Hospitals assigned to the QI program arm will participate in QI program initiatives and activities, such as webinars, coaching calls with experts and other online resources. Hospitals assigned to the Usual Care arm will continue with their standard hospital practice in treating patients with AF.

The primary objective will be measured by analyzing data collected on OAC use for each eligible AF patient around the time of hospital discharge. Secondary objectives include: evaluating the effect of the QI program versus Usual Care on the rate of readmission to the same hospital; determining whether hospital characteristics are predictive of improvement in rates of appropriate OAC use; and evaluating the effect of the QI program on OAC use. The study is expected to last approximately 20 months.

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