Stroke Treatment With Acute Reperfusion and Simvastatin
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01073007 |
Recruitment Status :
Completed
First Posted : February 22, 2010
Last Update Posted : December 21, 2016
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The purpose of this study is to determine whether simvastatin treatment started within the first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at seventh day/discharge or at the third month.
Also, to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke, Acute | Drug: Simvastatin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Multicentric, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Simvastatin in the Acute Phase of Ischemic Stroke |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Simvastatin
Simvastatin 40 mg daily for 3 months.
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Drug: Simvastatin
Simvastatin 40 mgrs daily for three months. |
Placebo Comparator: Placebo |
Drug: Simvastatin
Simvastatin 40 mgrs daily for three months. |
- The primary outcome of this study is to determine whether simvastatin treatment started within the first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at seventh day/discharge or at the third month. [ Time Frame: Seventh day (or discharge) and third month ]
- The secondary outcome of this study is to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis. [ Time Frame: 24 to 78 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients older than 18 years acute ischemic stroke (less than 12 hours from stroke onset).
- Stroke involving MCA-ACA-PCA.
- NIHSS score 4 to 22.
- Previous modified Rankin Scale score of 1 or 0.
- Patient or proxy informed consent.
- Patients not taking statins for the past six months.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Clinical or radiological evidence on admission of intracranial hemorrhage, hemorrhagic infarction or tumor.
- Seizures at the time of inclusion.
- Complete or substantial recovery prior to randomization.
- Patients with ipsilateral neurological deficit that may mask the evaluation of the current event.
- Liver disease (AST or ALT more than twice upper normality limit).
- Cardiogenic shock or relevant cardiac failure.
- Patients with more than five times upper normality limit of CPK.
- Myocardial infarction or any other thromboembolic event within the previous 30 days.
- Active infection by the time of inclusion.
- Documented hypersensibility to statins.
- Drug abuse.
- Expected short life-expectancy related to other systemic diseases.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073007

Study Director: | Joan Montaner, MD, PhD | Hospital Vall Hebron Research Institute | |
Principal Investigator: | Marc Ribó, MD, PhD | Hospital Vall Hebron. Stroke Unit | |
Principal Investigator: | Carmen Jimenez, MD | Hospital Son Dureta. Stroke Unit. | |
Principal Investigator: | Francesc Muñoz, MD | Hospital de Mollet | |
Principal Investigator: | David Canovas, MD | Consorci Sanitari Parc Taulí Sabadell. | |
Principal Investigator: | Jurek Krupinski, MD | Hospital Mutua de Terrassa. Neurology Department | |
Principal Investigator: | Maite Martinez-Zabaleta, MD | Hospital de Donostia. Neurology Department | |
Principal Investigator: | Francisco Javier De la Torre Laviana, MD | Hospital Virgen del Rocio. Stroke Unit. | |
Principal Investigator: | Marimar Freijo, MD | Hospital de Basurto | |
Principal Investigator: | Tomás Segura, MD | Hospital Universitario de Albacete | |
Principal Investigator: | Juan Arenillas, MD, PhD | Hospital Universitario de Valladolid | |
Principal Investigator: | Jose Manuel Flores, MD | Hospital de Ciudad Real | |
Principal Investigator: | Francisco Alonso, MD, PhD | Hospital General de Vic | |
Principal Investigator: | Jaime Masjuán Vallejo, MD | Hospital Universitario Ramón y Cajal. Stroke unit. | |
Principal Investigator: | Francisco Rubio Borrego, MD, PhD | Hospital Universitario de Bellvitge. Stroke Unit. | |
Principal Investigator: | Javier Tejada García, MD | Hospital de Leon | |
Principal Investigator: | Aida Lago Martín, MD, PhD | Hospital Universitario la Fe. Stroke Unit. | |
Principal Investigator: | Yolanda Bravo Anguiano, MD | Hospital General Yagüe | |
Principal Investigator: | Xavier Ustrell Roig, MD, PhD | Hospital Universitario Joan XXIII | |
Principal Investigator: | Francisco Purroy García, MD, PhD | Hospital Universitario Arnau de Vilanova de Lleida | |
Principal Investigator: | Raquel Delgado Mederos, MD, PhD | Hospital Santa Creu i Sant Pau |
Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | NCT01073007 |
Other Study ID Numbers: |
STARS07 EC07/90195 ( Other Identifier: Fondo de Investigación Sanitaria ) |
First Posted: | February 22, 2010 Key Record Dates |
Last Update Posted: | December 21, 2016 |
Last Verified: | June 2014 |
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