Stroke Treatment With Acute Reperfusion and Simvastatin
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2014 by Hospital Universitari Vall d'Hebron Research Institute
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: March 31, 2014
Last verified: March 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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 340 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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
Contacts
| Contact: Joan Montaner, MD, PhD | 93-4894029 ext 4029 | 31862jmv@comb.cat |
Locations
| Spain | |
| Hospital General de Vic | Recruiting |
| Vic, Barcelona, Spain | |
| Principal Investigator: Francisco Alonso, MD | |
| Hospital Universitario de Albacete | Recruiting |
| Albacete, Spain | |
| Principal Investigator: Tomás Segura, MD | |
| Hospital Universitario Vall d'Hebron | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Marc Ribo, MD | |
| Hospital de Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Raquel Delgado Mederos, MD | |
| Hospital Universitario de Bellvitge | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Francisco Rubio Borrego, MD | |
| Hospital de Basurto | Recruiting |
| Bilbao, Spain | |
| Principal Investigator: Marimar Freijo, MD | |
| Hospital General Yagüe | Recruiting |
| Burgos, Spain | |
| Principal Investigator: Yolanda Bravo Anguiano, MD | |
| Hospital de Ciudad Real | Not yet recruiting |
| Ciudad Real, Spain | |
| Principal Investigator: Jose Manuel Flores, MD | |
| Hospital de Donostia | Recruiting |
| Donostia, Spain | |
| Principal Investigator: Maite Martinez-Zabaleta, MD | |
| Hospital de León | Recruiting |
| León, Spain | |
| Principal Investigator: Javier Tejada García, MD | |
| Hospital Arnau de Vilanova de Lleida | Recruiting |
| Lleida, Spain | |
| Principal Investigator: Francisco Purroy García, MD | |
| Hospital Universitario Ramón y Cajal | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Jaime Masjuán Vallejo, MD | |
| Hospital de Mollet | Recruiting |
| Mollet del Vallès, Spain | |
| Principal Investigator: Francesc Muñoz, MD | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Spain | |
| Principal Investigator: Carmen Jimenez, MD | |
| Consorci Sanitari Parc Tauli | Recruiting |
| Sabadell, Spain | |
| Principal Investigator: David Canovas, MD | |
| Hospital Virgen del Rocío | Recruiting |
| Sevilla, Spain | |
| Principal Investigator: Francisco Javier De la Torre Laviana, MD | |
| Hospital Universitario Joan XXIII | Not yet recruiting |
| Tarragona, Spain | |
| Principal Investigator: Xavier Ustrell Roig, MD | |
| Hospital Mutua de Terrassa | Recruiting |
| Terrassa, Spain | |
| Principal Investigator: Jurek Krupinski, MD | |
| Hospital Universitario La Fe | Recruiting |
| Valencia, Spain | |
| Principal Investigator: Aida lago Martín, MD | |
| Hospital Universitario de Valladolid | Recruiting |
| Valladolid, Spain | |
| Principal Investigator: Juan Francisco Arenillas, MD | |
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
No publications provided
| Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT01073007 History of Changes |
| Other Study ID Numbers: | STARS07, EC07/90195 |
| Study First Received: | February 18, 2010 |
| Last Updated: | March 31, 2014 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
|
Acute Stroke tissue plasminogen activator simvastatin |
Additional relevant MeSH terms:
|
Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases Simvastatin Anticholesteremic Agents |
Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015