Montaner Joan, Bustamante Alejandro, García-Matas Silvia, Martínez-Zabaleta Maite, Jiménez Carmen, de la Torre Javier, Rubio Francisco R, Segura Tomás, Masjuán Jaime, Cánovas David, Freijo Mar, Delgado-Mederos Raquel, Tejada Javier, Lago Aida, Bravo Yolanda, Corbeto Natália, Giralt Dolors, Vives-Pastor Bárbara, de Arce Anna, Moniche Francisco, Delgado Pilar, Ribó Marc
From the Stroke Unit, Department of Neurology (J.M., M.R.), Neurovascular Research Laboratory, Institut de Recerca-Universitat Autónoma de Barcelona (J.M., A.B., N.C., D.G., P.D.), and Vall d' Hebron Institut d'Oncologia (S.G.-M.), Hospital Universitari Vall d'Hebron, Barcelona, Spain; Neurovascular Unit, Department of Neurology, Hospital Universitario Donostia, Donostia-San Sebastian, Spain (M.M.-Z., A.A.); Department of Neurology, Hospital Universitari Son Espases, Palma de Mallorca, Spain (C.J., B.V.-P.); Stroke Program, Institute of Biomedicine of Seville, Hospital Universitario Virgen del Rocio, Seville, Spain (J.T., F.M.); Department of Neurology, Hospital Universitari de Bellvitge, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain (F.R.R.); Department of Neurology, Hospital Universitario Virgen de la Victoria, Albacete, Spain (T.S.); Stroke Unit, Department of Neurology, IRYCIS, University Hospital Ramón y Cajal, Madrid, Spain (J.M.); Department of Neurology, Hospital Universitari Parc Tauli, Sabadell, Spain (D.C.); Department of Neurology, Hospital de Basurto, Bilbao, Spain (M.F.); Department of Neurology, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau, Barcelona, Spain (R.D.-M.); Department of Neurology, Hospital Universitario de León, Spain (J.T.); Stroke Unit, Department of Neurology, Hospital Universitari la Fe, Valencia, Spain (A.L.); and Department of Neurology, Hospital Universitari General Yagüe, Burgos, Spain (Y.B.).
Stroke. 2016 Nov;47(11):2870-2873. doi: 10.1161/STROKEAHA.116.014600. Epub 2016 Oct 6.
The STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin) was conducted to demonstrate the efficacy and safety of simvastatin treatment in acute stroke.
STARS07 was a multicentre, phase IV, prospective, randomized, double-blind, placebo-controlled trial. Patients with Acute ischemic stroke recruited within 12 hours from symptom onset were randomized to oral simvastatin 40 mg or placebo, once daily for 90 days. Primary outcome was proportion of independent patients (modified Rankin Scale score of ≤2) at 90 days. Safety end points were hemorrhagic transformation, hemorrhagic events, death, infections, and serious adverse events.
From April 2009 to March 2014, 104 patients were included. Fifty-five patients received intravenous tissue-type plasminogen activator. No differences were found between treatment arms regarding the primary outcome (adjusted odds ratio, 0.99 [0.35-2.78]; P=0.98). Concerning safety, no significant differences were found in the rate of hemorrhagic transformation of any type, nor symptomatic hemorrhagic transformation. There were no differences in other predefined safety outcomes. In post hoc analyses, for patients receiving tissue-type plasminogen activator, a favorable effect for simvastatin treatment was noted with higher proportion of patients experiencing major neurological recovery (adjusted odds ratio, 4.14 [1.18-14.4]; P=0.02).
Simvastatin plus tissue-type plasminogen activator combination seems safe in acute stroke, with low rates of bleeding complications. Because of the low recruitment, the STARS trial was underpowered to detect differences in simvastatin efficacy.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01073007.
开展STARS试验（急性再灌注与辛伐他汀治疗卒中）以证明辛伐他汀治疗急性卒中的疗效和安全性。
STARS07是一项多中心、IV期、前瞻性、随机、双盲、安慰剂对照试验。症状发作后12小时内招募的急性缺血性卒中患者被随机分为口服40毫克辛伐他汀或安慰剂组，每日一次，共90天。主要结局是90天时独立患者（改良Rankin量表评分≤2）的比例。安全性终点为出血性转化、出血事件、死亡、感染和严重不良事件。
2009年4月至2014年3月，纳入104例患者。55例患者接受了静脉注射组织型纤溶酶原激活剂。治疗组之间在主要结局方面未发现差异（调整后的优势比，0.99 [0.35 - 2.78]；P = 0.98）。在安全性方面，任何类型的出血性转化率或症状性出血性转化均未发现显著差异。其他预先定义的安全性结局也没有差异。在事后分析中，对于接受组织型纤溶酶原激活剂的患者，辛伐他汀治疗有有利作用，经历主要神经功能恢复的患者比例更高（调整后的优势比，4.14 [1.18 - 14.4]；P = 0.02）。
辛伐他汀加组织型纤溶酶原激活剂联合治疗在急性卒中中似乎安全，出血并发症发生率低。由于入组人数少，STARS试验检测辛伐他汀疗效差异的能力不足。
