Wan-Yong Yang1,2, Yu-Feng Li1,2, Zi-Ran Wang3, Tian-Xia Yu4, Dong-Juan Xu5, Nan Yang6, Xiao-Yuan Niu7, Xue-Li Cai8, Wen-Yan Zhuo9, Xue-Mei Wu10, Min Yan11, Jun-Shan Zhou12, Hao-Wen Zhang13, Zhi-Gang Liang14, Wen-Jun Wu15, Jian-Hua Cheng16, Li-An Huang1,2, Yu-Sheng Zhang1,2, Ying Guan17, Ze-Feng Tan1,2, Dan Lu1,2, Niu He1,2, Da-Wei Dong1,2, Hui-Li Zhu1,2, Bing Yang1,2, Qing-Yu Shen18, An-Ding Xu19,20. 1. Department of Neurology and Stroke Center, The First Affiliated Hospital of Jinan University, Jinan University, Guangzhou, 510630, China. 2. Clinical Neuroscience Institute, The First Affiliated Hospital of Jinan University, Jinan University, Guangzhou, 510630, China. 3. Department of Neurology and Stroke Center, Linyi People's Hospital, Linyi, 276003, China. 4. Department of Neurology, Yan Tai Shan Hospital, Yantai, 264000, China. 5. Department of Neurology, Dongyang Affiliated Hospital of Wenzhou Medical University, Dongyang, 322100, China. 6. Department of Neurology, Traditional Chinese Medicine Hospital of Zhongshan City, Zhongshan, 528400, China. 7. Department of Neurology, First Hospital of Shanxi Medical University, Taiyuan, 030000, China. 8. Department of Neurology, Lishui Hospital of Zhejiang University, The Central Hospital of Lishui, Lishui, 323000, China. 9. Department of Neurology, Zhuhai Hospital Affiliated With Jinan University, Zhuhai, 519000, China. 10. Department of Neurology, General Hospital of TISCO, Taiyuan, 030000, China. 11. Jingdong Medical District, General Hospital of the Chinese People's Liberation Army, Beijing, 100853, China. 12. Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, 210000, China. 13. Department of Neurology, Laixi City People's Hospital, Qingdao, 266600, China. 14. Department of Neurology, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, 264000, China. 15. Department of Neurology, Zhongshan City People's Hospital, Zhongshan, 528403, China. 16. Department of Neurology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325000, China. 17. Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, 510515, China. 18. Department of Neurology, Sun-Yet Sen Memorial Hospital of Sun-Yet Sen University, Guangzhou, 510120, China. shenqy@mail.sysu.edu.cn. 19. Department of Neurology and Stroke Center, The First Affiliated Hospital of Jinan University, Jinan University, Guangzhou, 510630, China. tlil@jnu.edu.cn. 20. Clinical Neuroscience Institute, The First Affiliated Hospital of Jinan University, Jinan University, Guangzhou, 510630, China. tlil@jnu.edu.cn.
Abstract
OBJECTIVE: To investigate the safety and efficacy of intensive statin in the acute phase of ischemic stroke after intravenous thrombolysis therapy. METHODS: A total of 310 stroke patients treated with rt-PA were randomly scheduled into the intensive statin group (rosuvastatin 20 mg daily × 14 days) and the control group (rosuvastatin 5 mg daily × 14 days). The primary clinical endpoint was excellent functional outcome (mRS ≤ 1) at 3 months, and the primary safety endpoint was symptomatic intracranial hemorrhage (sICH) in 90 days. RESULTS: The intensive statin users did not achieve a favorable outcome in excellent functional outcome (mRS ≤ 1) at 3 months compared with controls (70.3% vs. 66.5%, p = 0.464). Intensive statin also not significantly improved the overall distribution of scores on the modified Rankin scale, as compared with controls (p = 0.82 by the Cochran-Mantel-Haenszel test). The incidence of primary safety endpoint events (sICH) in 90 days did not significantly differ between the intensive statin group and control group (0.6% vs. 1.3%, p > 0.999). CONCLUSION: The INSPIRE study indicated that intensive statin therapy may not improve clinical outcomes compared with the low dose of statin therapy in AIS patients undergoing intravenous thrombolysis, and the two groups had similar safety profile. CLINICAL TRIAL REGISTRATION: URL: http://www.chictr.org . Unique identifier: ChiCTR-IPR-16008642.
RCT Entities:
OBJECTIVE: To investigate the safety and efficacy of intensive statin in the acute phase of ischemic stroke after intravenous thrombolysis therapy. METHODS: A total of 310 strokepatients treated with rt-PA were randomly scheduled into the intensive statin group (rosuvastatin 20 mg daily × 14 days) and the control group (rosuvastatin 5 mg daily × 14 days). The primary clinical endpoint was excellent functional outcome (mRS ≤ 1) at 3 months, and the primary safety endpoint was symptomatic intracranial hemorrhage (sICH) in 90 days. RESULTS: The intensive statin users did not achieve a favorable outcome in excellent functional outcome (mRS ≤ 1) at 3 months compared with controls (70.3% vs. 66.5%, p = 0.464). Intensive statin also not significantly improved the overall distribution of scores on the modified Rankin scale, as compared with controls (p = 0.82 by the Cochran-Mantel-Haenszel test). The incidence of primary safety endpoint events (sICH) in 90 days did not significantly differ between the intensive statin group and control group (0.6% vs. 1.3%, p > 0.999). CONCLUSION: The INSPIRE study indicated that intensive statin therapy may not improve clinical outcomes compared with the low dose of statin therapy in AISpatients undergoing intravenous thrombolysis, and the two groups had similar safety profile. CLINICAL TRIAL REGISTRATION: URL: http://www.chictr.org . Unique identifier: ChiCTR-IPR-16008642.
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