Journal
JOURNAL OF NEUROLOGY
Volume 268, Issue 7, Pages 2560-2569Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00415-020-10388-3
Keywords
Acute ischemic stroke; Statin; Intravenous thrombolysis; Symptomatic intracranial hemorrhage; Good functional outcome
Categories
Funding
- National Natural Science Foundation of China [81171084, 81671167, 81801150]
- Guangzhou Science and Technology Program of China [2014Y2-00505]
- Science and Technology Program of Guangdong, China [2014A030313384, 201508020004, 2017A020215049]
- Guangdong Natural Science Foundation [2018A0303130182]
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The study showed that intensive statin therapy did not significantly improve clinical outcomes compared to low-dose statin therapy in patients with acute ischemic stroke undergoing intravenous thrombolysis, and both treatment groups had similar safety profiles.
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 x 14 days) and the control group (rosuvastatin 5 mg daily x 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
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