UK's Stroke Research Network Adopts Gore REDUCE Clinical Study


June 19, 2012—Gore & Associates (Flagstaff, AZ) announced that the United Kingdom's National Institute for Health Research Stroke Research Network (NIHR SRN) has adopted the Gore REDUCE clinical study to help encourage patient recruitment across England.

In its press release, the company explained that the Gore REDUCE clinical study is designed to demonstrate that patent foramen ovale (PFO) closure with the Gore septal occluder plus antiplatelet medical management reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and a history of cryptogenic stroke or imaging-confirmed TIA. The prospective, randomized, multicenter, multinational trial will include up to 80 investigational sites in the United States, Europe, and Canada. The REDUCE trial commenced enrollment in the United Kingdom in November 2011, as reported in Cardiac Interventions Today.



According to Gore, the NIHR SRN supports vital stroke studies, such as the Gore REDUCE clinical study, by providing coordination, leadership, and practical help. It supports both academic research and industry-sponsored studies, offering 100% coverage of the National Health Service hospitals nationwide. Established in 2006, the network has increased patient recruitment six-fold. It also provides a patient and career involvement program to impact both the quality and delivery of stroke research.

In the company's press release, trial investigator David Hildick-Smith, MD, who is Director of the Cardiac Research Unit at Brighton and Sussex University Hospitals, commented, “PFO closure is known as a low-risk treatment; therefore, patient enrollment remains a challenge for all closure studies because many patients are not willing to be randomized. Stroke Research Network adoption of REDUCE will help drive recruitment in this pivotal trial thus resolving this all too common issue. REDUCE is being run with Gore's customary attention to detail, and I expect it to be a high-quality and well-respected trial.”

The company stated that patients in the Gore REDUCE clinical study are randomized to one of two treatment arms: either antiplatelet medical management alone or device closure of the PFO in conjunction with antiplatelet medical management. The primary endpoint is freedom from recurrent ischemic stroke, imaging-confirmed TIA, or death due to stroke through 24 months after randomization.