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Stroke Treatment With Acute Reperfusion and Simvastatin
This study has been completed.
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01073007
First received: February 18, 2010
Last updated: December 20, 2016
Last verified: June 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Stroke, Acute | Drug: Simvastatin | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 104 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Simvastatin
Simvastatin 40 mg daily for 3 months.
|
Drug: Simvastatin
Simvastatin 40 mgrs daily for three months.
|
| Placebo Comparator: Placebo |
Drug: Simvastatin
Simvastatin 40 mgrs daily for three months.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073007
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073007
Locations
| Spain | |
| Hospital General de Vic | |
| Vic, Barcelona, Spain | |
| Hospital Universitario de Albacete | |
| Albacete, Spain | |
| Hospital de Santa Creu i Sant Pau | |
| Barcelona, Spain | |
| Hospital Universitario de Bellvitge | |
| Barcelona, Spain | |
| Hospital Universitario Vall d'Hebron | |
| Barcelona, Spain | |
| Hospital de Basurto | |
| Bilbao, Spain | |
| Hospital General Yagüe | |
| Burgos, Spain | |
| Hospital de Ciudad Real | |
| Ciudad Real, Spain | |
| Hospital de Donostia | |
| Donostia, Spain | |
| Hospital de León | |
| León, Spain | |
| Hospital Arnau de Vilanova de Lleida | |
| Lleida, Spain | |
| Hospital Universitario Ramón y Cajal | |
| Madrid, Spain | |
| Hospital de Mollet | |
| Mollet del Vallès, Spain | |
| Hospital Son Dureta | |
| Palma de Mallorca, Spain | |
| Consorci Sanitari Parc Tauli | |
| Sabadell, Spain | |
| Hospital Virgen del Rocío | |
| Sevilla, Spain | |
| Hospital Universitario Joan XXIII | |
| Tarragona, Spain | |
| Hospital Mutua de Terrassa | |
| Terrassa, Spain | |
| Hospital Universitario La Fe | |
| Valencia, Spain | |
| Hospital Universitario de Valladolid | |
| Valladolid, Spain | |
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
| 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 León |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT01073007 History of Changes |
| Other Study ID Numbers: |
STARS07 EC07/90195 ( Other Identifier: Fondo de Investigación Sanitaria ) |
| Study First Received: | February 18, 2010 |
| Last Updated: | December 20, 2016 |
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
|
Acute Stroke tissue plasminogen activator simvastatin |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Simvastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 21, 2017