Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial
| Autor: | Hyo Suk Nam, Jin Kyo Choi, Yoonkyung Chang, Kwon-Duk Seo, Bang-Hoon Cho, Hye S. Lee, Minyoul Baik, Seong Hwan Ahn, Yo Han Jung, Tae Jin Song, Jun Young Chang, JoonNyung Heo, Sungha Park, Dong Joon Kim, Han-Jin Cho, Jong-Won Chung, Jung Hwa Seo, Gyu Sik Kim, Goeun Park, Chan Joo Lee, Hyungjong Park, Sung Il Sohn, Jang Hyun Baek, Jun Lee, Jae Guk Kim, Woo-Keun Seo, Jinkwon Kim, Joonsang Yoo, Jeong-Ho Hong, Oh Young Bang, Byung Moon Kim, Yang-Ha Hwang, Kijeong Lee, Kyung-Yul Lee, Dong Hoon Shin, Sun U. Kwon, Chi Kyung Kim, Young Dae Kim |
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| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | International Journal of Stroke. 17:931-937 |
| ISSN: | 1747-4949 1747-4930 |
| Popis: | Rationale Very early stage blood pressure (BP) levels may affect outcome in stroke patients who have successfully undergone recanalization following intra-arterial treatment, but the optimal target of BP management remains uncertain. Aim We hypothesized that the clinical outcome after intensive BP-lowering is superior to conventional BP control after successful recanalization by intra-arterial treatment. Sample-size estimates We aim to randomize 668 patients (334 per arm), 1:1. Methods and design We initiated a multicenter, prospective, randomized, open-label trial with a blinded end-point assessment (PROBE) design. After successful recanalization (thrombolysis in cerebral infarction score ≥ 2 b), patients with elevated systolic BP level, defined as the mean of two readings ≥ 140 mmHg, will be randomly assigned to the intensive BP-lowering (systolic BP Study outcomes The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at three months (mRS scores: 0–2 vs. 3–6). The primary safety outcomes are symptomatic intracerebral hemorrhage and death within three months. Discussion The OPTIMAL-BP trial will provide evidence for the effectiveness of active BP control to achieve systolic BP Clinical trial registration ClinicalTrials.gov Identifier: NCT04205305. |
| Databáze: | OpenAIRE |
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