Janssen and Premier to initiate stroke risk management study among AF patients


Janssen Pharmaceuticals has collaborated with Premier on the first and largest study of its kind to address an unmet medical need for hospitalised patients with atrial fibrillation (AF) who are at risk for ischaemic 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 programme on oral anticoagulant use in these patients.

This prospective, parallel-group, cluster-randomised study will involve approximately 150 hospitals which researchers will assign in a 1:1 ratio either to the quality improvement programme arm or to the usual care arm. The study will determine whether the implementation of a quality improvement programme, 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 oral anticoagulant.

Hospitals assigned to the quality improvement programme arm will participate in programme 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 analysing data collected on oral anticoagulant use for each eligible AF patient around the time of hospital discharge. Secondary objectives include: evaluating the effect of the quality improvement programme versus usual care on the rate of readmission to the same hospital; determining whether hospital characteristics are predictive of improvement in rates of appropriate oral anticoagulant use; and evaluating the effect of the quality improvement program on oral anticoagulant use. The study is expected to last approximately 20 months.