Stroke, AcutePhase 4NCT01073007

Stroke Treatment With Acute Reperfusion and Simvastatin

A Phase 4 study testing Simvastatin in people with Stroke, Acute, run by Hospital Universitari Vall d'Hebron Research Institute at 20 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Acute
What is being tested?: Simvastatin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 20 sitesSpain
Study dates: Apr 2009to Jun 2014
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 13Show fewer

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.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Spain20 sites

Hospital Universitario de Albacete
Albacete
Hospital de Santa Creu i Sant Pau
Barcelona
Hospital Universitario de Bellvitge
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital de Basurto
Bilbao
Hospital General Yagüe
Burgos
Hospital de Ciudad Real
Ciudad Real
Hospital de Donostia
Donostia / San Sebastian
Hospital de León
León
Hospital Arnau de Vilanova de Lleida
Lleida
Hospital Universitario Ramón y Cajal
Madrid
Hospital de Mollet
Mollet del Vallès
Hospital Son Dureta
Palma de Mallorca
Consorci Sanitari Parc Tauli
Sabadell
Hospital Virgen del Rocío
Seville
Hospital Universitario Joan XXIII
Tarragona
Hospital Mutua de Terrassa
Terrassa
Hospital Universitario La Fe
Valencia
Hospital Universitario de Valladolid
Valladolid
Hospital General de Vic
Vic, Barcelona

Other trials in Spain

About this study

Official title: Multicentric, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Simvastatin in the Acute Phase of Ischemic Stroke

Also, to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis.

Conditions: Stroke, Acute
Being tested: Simvastatin
Keywords: Acute Stroke, tissue plasminogen activator, simvastatin
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SimvastatinDrug
Simvastatin 40 mgrs daily for three months.

Study groups in NCT01073007
Study group	Role	What they receive
Simvastatin	Experimental	Simvastatin 40 mg daily for 3 months. Receives: Drug: Simvastatin
Placebo	Placebo comparator	Not described Receives: Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Seventh day (or discharge) and third month

Secondary outcomes (1)

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.
Measured: 24 to 78 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jun 2014

First posted22 Feb 2010 (estimated)
Study startApr 2009
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stroke, AcuteStudies of the same condition, open and under way.
More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01073007
Sponsor's protocol ID: STARS07
Other IDs: EC07/90195
Status last verified: Jun 2014
First submitted: 18 Feb 2010
Last updated: 21 Dec 2016
Results posted: No
Data monitoring committee: Yes

Publications

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. 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. doi: 10.1161/STROKEAHA.116.014600. Epub 2016 Oct 6.
PubMed 27758944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

All Stroke, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentric, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Simvastatin in the Acute Phase of Ischemic Stroke
ClinicalTrials.gov ID: NCT01073007
Acronym / sponsor ID: STARS07
Conditions: Stroke, Acute
Keywords: Acute Stroke, tissue plasminogen activator, simvastatin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
Study start: Apr 2009
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 22 Feb 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Also, to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Simvastatin	Experimental	Drug: SimvastatinSimvastatin 40 mg daily for 3 months.
Placebo	Placebo comparator	Drug: Simvastatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SimvastatinSimvastatin 40 mgrs daily for three months.	Drug	Placebo, Simvastatin

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
Derived from this study: PubMed 27758944Montaner 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. 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. doi: 10.1161/STROKEAHA.116.014600. Epub 2016 Oct 6.

Related trials for Stroke, Acute

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joan Montaner, MD, PhD study director

Hospital Vall Hebron Research Institute

Marc Ribó, MD, PhD principal investigator

Hospital Vall Hebron. Stroke Unit

Carmen Jimenez, MD principal investigator

Hospital Son Dureta. Stroke Unit.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Simvastatin in people with Stroke, Acute, run by Hospital Universitari Vall d'Hebron Research Institute at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01073007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.