RT Journal Article
T1 Combination of Thrombolysis and Statins in Acute Stroke Is Safe: Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin).
A1 Montaner, Joan
A1 Bustamante, Alejandro
A1 Garcia-Matas, Silvia
A1 Martinez-Zabaleta, Maite
A1 Jimenez, Carmen
A1 de-la-Torre, Javier
A1 Rubio, Francisco R
A1 Segura, Tomas
A1 Masjuan, Jaime
A1 Canovas, David
A1 Freijo, Mar
A1 Delgado-Mederos, Raquel
A1 Tejada, Javier
A1 Lago, Aida
A1 Bravo, Yolanda
A1 Corbeto, Natalia
A1 Giralt, Dolors
A1 Vives-Pastor, Barbara
A1 de-Arce, Anna
A1 Moniche, Francisco
A1 Delgado, Pilar
A1 Ribo, Marc
K1 clinical trial
K1 neuroprotection
K1 simvastatin
K1 stroke
K1 thrombolysis
AB 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. 
PB Lippincott Williams & Wilkins
YR 2016
FD 2016-10-06
LK http://hdl.handle.net/10668/10546
UL http://hdl.handle.net/10668/10546
LA en
NO Montaner J, Bustamante A, García-Matas S, Martínez-Zabaleta M, Jiménez C, de la Torre J, et al. Combination of Thrombolysis and Statins in Acute Stroke Is Safe: Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin). Stroke. 2016 Nov;47(11):2870-2873.
DS RISalud
RD Apr 19, 2025