{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T02:09:12Z","timestamp":1789006152304,"version":"build-2803163510"},"reference-count":19,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2024,8,15]],"date-time":"2024-08-15T00:00:00Z","timestamp":1723680000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100014219","name":"National Science Fund for Distinguished Young Scholars","doi-asserted-by":"publisher","award":["82025013"],"award-info":[{"award-number":["82025013"]}],"id":[{"id":"10.13039\/501100014219","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National High Level Hospital Clinical Research Funding","award":["2022-PUMCH-C-001"],"award-info":[{"award-number":["2022-PUMCH-C-001"]}]},{"DOI":"10.13039\/501100019018","name":"Chinese Academy of Medical Sciences Initiative for Innovative Medicine","doi-asserted-by":"publisher","award":["No.2022-I2M-1-001"],"award-info":[{"award-number":["No.2022-I2M-1-001"]}],"id":[{"id":"10.13039\/501100019018","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Stroke"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:sec>\n                    <jats:title>Rationale:<\/jats:title>\n                    <jats:p>Proprotein convertase subtilisin\/kexin type 9 (PCSK9) inhibitors enable an additional 54\u201375% reduction in low-density lipoprotein cholesterol (LDL-C) in statin-treated patients, demonstrating plaque regression in coronary artery disease. However, the impact of achieving an extremely low level of LDL-C with PCSK9 inhibitors (e.g. Evolocumab) on symptomatic intracranial atherosclerosis remains unexplored.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim and hypothesis:<\/jats:title>\n                    <jats:p>To determine whether combining Evolocumab and statins achieves a more significant symptomatic intracranial plaque regression than statin therapy alone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Sample size estimates:<\/jats:title>\n                    <jats:p>With a sample size of 1000 subjects, a two-sided \u03b1 of 0.05, and 20% lost to follow-up, the study will have 83.3% power to detect the difference in intracranial plaque burden.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and design:<\/jats:title>\n                    <jats:p>This is an investigator-initiated multicenter, randomized, open-label, outcome assessor-blinded trial, evaluating the impact of combining Evolocumab and statins on intracranial plaque burden assessed by high-resolution magnetic resonance imaging at baseline in patients undergoing a clinically indicated acute stroke or transient ischemic attack due to intracranial artery stenosis, and after 24\u2009weeks of treatment. Subjects (n\u2009=\u20091000) were randomized 1:1 into two groups to receive either Evolocumab 140\u2009mg every 2\u2009weeks with statin therapy or statin therapy alone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study outcomes:<\/jats:title>\n                    <jats:p>The primary endpoint is the change in intracranial plaque burden assessed by high-resolution magnetic resonance imaging, performed at baseline and at the end of the 24-week treatment period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>This trial will explore whether more significant intracranial plaque regression is achievable with the treatment of combining Evolocumab and statins, providing information about efficacy and safety data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number:<\/jats:title>\n                    <jats:p>ChiCTR2300068868; https:\/\/www.chictr.org.cn\/<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17474930241270447","type":"journal-article","created":{"date-parts":[[2024,7,30]],"date-time":"2024-07-30T01:00:51Z","timestamp":1722301251000},"page":"1071-1076","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["PCSK9 Inhibitor with Statin Therapy for Intracranial Artery Stenosis ( PISTIAS): Rationale and design of a multicenter randomized controlled trial"],"prefix":"10.1177","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-6304-5090","authenticated-orcid":false,"given":"Xinzhi","family":"Hu","sequence":"first","affiliation":[{"name":"Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical 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