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Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial

 Hyo Suk Nam  ;  Young Dae Kim  ;  Jin Kyo Choi  ;  Minyoul Baik  ;  Byung Moon Kim  ;  Dong Joon Kim  ;  JoonNyung Heo  ;  Dong Hoon Shin  ;  Kyung-Yul Lee  ;  Yo Han Jung  ;  Jang-Hyun Baek  ;  Yang-Ha Hwang  ;  Sung-Il Sohn  ;  Jeong-Ho Hong  ;  Hyungjong Park  ;  Chi Kyung Kim  ;  Gyu Sik Kim  ;  Kwon-Duk Seo  ;  Kijeong Lee  ;  Jung Hwa Seo  ;  Oh Young Bang  ;  Woo-Keun Seo  ;  Jong-Won Chung  ;  Jun Young Chang  ;  Sun U Kwon  ;  Jun Lee  ;  Jinkwon Kim  ;  Joonsang Yoo  ;  Tae-Jin Song  ;  Seong Hwan Ahn  ;  Bang-Hoon Cho  ;  Han-Jin Cho  ;  Jae Guk Kim  ;  Yoonkyung Chang  ;  Chan Joo Lee  ;  Sungha Park  ;  Goeun Park  ;  Hye S Lee 
 INTERNATIONAL JOURNAL OF STROKE, Vol.17(8) : 931-937, 2022-10 
Journal Title
Issue Date
Reperfusion therapy ; blood pressure ; cerebral infarction ; outcome research
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 < 140 mm Hg) group or the conventional BP-lowering (systolic BP, 140-180 mm Hg) group.

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 < 140 mmHg during 24 h in patients with successful recanalization after intra-arterial treatment.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT04205305.
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Neurology (신경과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Yonsei Biomedical Research Center (연세의생명연구원) > 1. Journal Papers
Yonsei Authors
Kim, Dong Joon(김동준) ORCID logo https://orcid.org/0000-0002-7035-087X
Kim, Byung Moon(김병문) ORCID logo https://orcid.org/0000-0001-8593-6841
Kim, Young Dae(김영대) ORCID logo https://orcid.org/0000-0001-5750-2616
Kim, Jinkwon(김진권) ORCID logo https://orcid.org/0000-0003-0156-9736
Nam, Hyo Suk(남효석) ORCID logo https://orcid.org/0000-0002-4415-3995
Park, Goeun(박고은)
Park, Sung Ha(박성하) ORCID logo https://orcid.org/0000-0001-5362-478X
Baik, Minyoul(백민렬)
Yoo, Joon Sang(유준상) ORCID logo https://orcid.org/0000-0003-1169-6798
Lee, Kyung Yul(이경열) ORCID logo https://orcid.org/0000-0001-5585-7739
Lee, Chan Joo(이찬주) ORCID logo https://orcid.org/0000-0002-8756-409X
Lee, Hye Sun(이혜선) ORCID logo https://orcid.org/0000-0001-6328-6948
Jung, Yo Han(정요한)
Heo, JoonNyung(허준녕)
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