{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T13:43:17Z","timestamp":1790516597579,"version":"4.1.0"},"reference-count":34,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2017,3,24]],"date-time":"2017-03-24T00:00:00Z","timestamp":1490313600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Stroke"],"published-print":{"date-parts":[[2017,12]]},"abstract":"<jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients who have had a cryptogenic stroke.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and design<\/jats:title>\n                    <jats:p>This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE\u00ae HELEX\u00ae Septal Occluder or GORE\u00ae CARDIOFORM Septal Occluder) or antiplatelet therapy alone. Subjects will be prospectively followed for up to five years. Neuroimaging is required for all subjects at baseline and at two years or study exit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study outcomes<\/jats:title>\n                    <jats:p>The two co-primary endpoints for the study are freedom from recurrent clinical ischemic stroke through at least 24 months post-randomization and incidence of new brain infarct (defined as clinical ischemic stroke or silent brain infarct) through 24 months. The primary analyses are an unadjusted log-rank test and a binomial test of subject-based proportions, respectively, both on the intent-to-treat population, with adjustment for testing multiplicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The REDUCE trial aims to target a patient population with truly cryptogenic strokes. Medical therapy is limited to antiplatelet agents in both arms thereby reducing confounding. The trial should determine whether patent foramen ovale closure with the Gore septal occluders is safe and more effective than medical therapy alone for the prevention of recurrent clinical ischemic stroke or new silent brain infarct; the neuroimaging data will provide an opportunity to further support the proof of concept. The main results are anticipated in 2017.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p>Clinical trial registration-URL: http:\/\/clinicaltrials.gov\/show\/NCT00738894<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1747493017701152","type":"journal-article","created":{"date-parts":[[2017,3,24]],"date-time":"2017-03-24T06:00:43Z","timestamp":1490335243000},"page":"998-1004","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study"],"prefix":"10.1177","volume":"12","author":[{"given":"Scott E","family":"Kasner","sequence":"first","affiliation":[{"name":"Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Thomassen","sequence":"additional","affiliation":[{"name":"Department of Neurology, Haukeland University Hospital, Bergen, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"S\u00f8ndergaard","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John F","family":"Rhodes","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Nicklaus Children\u2019s Hospital, Miami, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Coby C","family":"Larsen","sequence":"additional","affiliation":[{"name":"W. L. Gore & Associates, Inc., Flagstaff, AZ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joth","family":"Jacobson","sequence":"additional","affiliation":[{"name":"W. L. Gore & Associates, Inc., Flagstaff, AZ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,3,24]]},"reference":[{"key":"bibr1-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.57.7.1222"},{"key":"bibr2-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.60.10.1394"},{"key":"bibr3-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e31821a44ad"},{"key":"bibr4-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.0000068408.82115.D2"},{"key":"bibr5-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa022066"},{"key":"bibr6-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.55.8.1172"},{"key":"bibr7-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1016\/j.jstrokecerebrovasdis.2014.01.017"},{"key":"bibr8-1747493017701152","doi-asserted-by":"publisher","DOI":"10.3988\/jcn.2013.9.2.103"},{"key":"bibr9-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1007\/s00234-009-0496-9"},{"key":"bibr10-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2012.02.021"},{"key":"bibr11-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.111.631648"},{"key":"bibr12-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2007.11.050"},{"key":"bibr13-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1301440"},{"key":"bibr14-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009639"},{"key":"bibr15-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1211716"},{"key":"bibr16-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.12.023"},{"key":"bibr17-1747493017701152","first-page":"465","volume":"1","author":"Billinger K","year":"2006","journal-title":"EuroIntervention"},{"key":"bibr18-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25106"},{"key":"bibr19-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25063"},{"key":"bibr20-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.110.600114"},{"key":"bibr21-1747493017701152","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-139-9-200311040-00010"},{"key":"bibr22-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa011503"},{"key":"bibr23-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0b013e318296aeca"},{"key":"bibr24-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19971130)16:22<2529::AID-SIM692>3.0.CO;2-J"},{"key":"bibr25-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1177\/1747493016643551"},{"key":"bibr26-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-12-56"},{"key":"bibr27-1747493017701152","doi-asserted-by":"crossref","first-page":"2872","DOI":"10.1161\/STROKEAHA.110.593376","volume":"41","author":"Furlan AJ","year":"2010","journal-title":"Stroke"},{"key":"bibr28-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1159\/000131083"},{"key":"bibr29-1747493017701152","doi-asserted-by":"publisher","DOI":"10.1161\/STR.0b013e3181f7d043"},{"key":"bibr30-1747493017701152","doi-asserted-by":"crossref","unstructured":"Messe SR, Gronseth G, Kent DM, et\u00a0al. 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