Combination of Thrombolysis and Statins in Acute Stroke Is Safe Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin)

Autor: Montaner, J, Bustamante, A, Garcia-Matas, S, Martinez-Zabaleta, M, Jimenez, C, de la Torre, J, Rubio, FR, Segura, T, Masjuan, J, Canovas, D, Freijo, M, Delgado-Mederos, R, Tejada, J, Lago, A, Bravo, Y, Corbeto, N, Giralt, D, Vives-Pastor, B, de Arce, A, Moniche, F, Delgado, P, Ribo, M, STARS Investigators
Rok vydání: 2016
Předmět:
Male
Simvastatin
medicine.medical_specialty
thrombolysis
medicine.medical_treatment
030204 cardiovascular system & hematology
Placebo
Brain Ischemia
law.invention
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Fibrinolytic Agents
Randomized controlled trial
Modified Rankin Scale
law
Internal medicine
Outcome Assessment
Health Care

medicine
Humans
simvastatin
Stroke
Aged
Aged
80 and over

Advanced and Specialized Nursing
business.industry
clinical trial
Thrombolysis
Odds ratio
Middle Aged
medicine.disease
stroke
Surgery
Clinical trial
Tissue Plasminogen Activator
Drug Therapy
Combination

Female
neuroprotection
Neurology (clinical)
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiology and Cardiovascular Medicine
business
030217 neurology & neurosurgery
medicine.drug
Zdroj: Stroke
r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
instname
STROKE
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
ISSN: 0039-2499
Popis: Background and Purpose— The STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin) was conducted to demonstrate the efficacy and safety of simvastatin treatment in acute stroke. Methods— 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. Results— 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). Conclusions— 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. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01073007.
Databáze: OpenAIRE