Ischemic StrokePhase 3NCT00221104
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
A Phase 3 study testing Pravastatin in people with Ischemic Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Pravastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,578 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2004to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
- Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
- Able to visit outpatient department
- Informed consent on the form.
Who cannot join
- Ischemic stroke of other determined cause according to the TOAST classification
- Ischemic heart disease and necessary to use statin
- Hemorrhagic disorders
- Platelet count <=100,000/ul within 3 months prior to study start
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start
- Serum creatinine >=2.0mg/dl within 3 months prior to study start
- A scheduled operation
- The presence of malignant disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke
Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.
- Conditions
- Ischemic Stroke
- Being tested
- Pravastatin
- Keywords
- stroke, brain ischemia, cerebrovascular accident, statin, hydroxymethylglutaryl-CoA reductase inhibitors, cholesterol, hypercholesterolemia, hyperlipidemia, multicenter studies, prospective studies, endpoint determination, randomized controlled trials, recurrence, pravastatin
- Medical subject headings
- Ischemic Stroke, Stroke, Brain Ischemia, Hypercholesterolemia, Hyperlipidemias, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin | Active comparator | Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints. Receives: Drug: Pravastatin |
| No intervention | No intervention | Patient has no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Stroke and TIA
Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)
Measured: up to 5 years
Secondary outcomes (4)
Incidence Rate of Atherothrombotic Infarction
Incidence rate of patients with atherothrombotic infarction
Measured: up to 5 years
Incidence Rate of Lacunar Infarction
Incidence rate of patients with lacunar infarction
Measured: up to 5 years
Incidence Rate of Cardioembolic Infarction
Incidence rate of patients with cardioembolic infarction
Measured: up to 5 years
Incidence Rate of Intracranial Hemorrhage
Incidence rate of patients with intracranial hemorrhage
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study start1 Mar 2004
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan, Hiroshima University
- Responsible party
- Sponsor
- Investigators
- Masayasu Matsumoto, MD, PhD, Principal investigator, Hiroshima University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221104
- Sponsor's protocol ID
- J-STARS
- Other IDs
- C000000207
- Status last verified
- Jun 2017
- First submitted
- 13 Sep 2005
- Last updated
- 25 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hosomi N, Kitagawa K, Nagai Y, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS Collaborators. Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.
PubMed 29511130Hosomi N, Nagai Y, Kitagawa K, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS collaborators. Pravastatin Reduces the Risk of Atherothrombotic Stroke when Administered within Six Months of an Initial Stroke Event. J Atheroscler Thromb. 2018 Mar 1;25(3):262-268. doi: 10.5551/jat.40196. Epub 2017 Sep 16.
PubMed 28924103Nakamura M, Fukukawa T, Kitagawa K, Nagai Y, Hosomi N, Minematsu K, Uchiyama S, Matsumoto M, Miyamoto Y; for J-STARS collaborators. Ten-year standardization of lipids and high-sensitivity C-reactive protein in a randomized controlled trial to assess the effects of statins on secondary stroke prevention: Japan Statin Treatment Against Recurrent Stroke. Ann Clin Biochem. 2018 Jan;55(1):128-135. doi: 10.1177/0004563217693651. Epub 2017 Jul 10.
PubMed 28135841
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke
- ClinicalTrials.gov ID
- NCT00221104
- Acronym / sponsor ID
- J-STARS
- Conditions
- Ischemic Stroke
- Keywords
- stroke, brain ischemia, cerebrovascular accident, statin, hydroxymethylglutaryl-CoA reductase inhibitors, cholesterol, hypercholesterolemia, hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,578 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan, Hiroshima University
- Study start
- 1 Mar 2004
- Primary completion
- Jul 2014 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 25 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pravastatin | Active comparator | Drug: PravastatinPatient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints. |
| No intervention | No intervention | –Patient has no intervention. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
- Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
- Able to visit outpatient department
- Informed consent on the form.
Key exclusion criteria (8 listed)
- Ischemic stroke of other determined cause according to the TOAST classification
- Ischemic heart disease and necessary to use statin
- Hemorrhagic disorders
- Platelet count <=100,000/ul within 3 months prior to study start
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start
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 |
|---|---|---|
| Pravastatin | Drug | Pravastatin |
Primary outcome
Incidence Rate of Stroke and TIA
Time frame: up to 5 years
Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)
4 secondary outcomes
Incidence Rate of Atherothrombotic Infarction
Time frame: up to 5 years
Incidence Rate of Lacunar Infarction
Time frame: up to 5 years
Incidence Rate of Cardioembolic Infarction
Time frame: up to 5 years
Incidence Rate of Intracranial Hemorrhage
Time frame: up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29511130Hosomi N, Kitagawa K, Nagai Y, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS Collaborators. Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.
- Derived from this study: PubMed 28924103Hosomi N, Nagai Y, Kitagawa K, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS collaborators. Pravastatin Reduces the Risk of Atherothrombotic Stroke when Administered within Six Months of an Initial Stroke Event. J Atheroscler Thromb. 2018 Mar 1;25(3):262-268. doi: 10.5551/jat.40196. Epub 2017 Sep 16.
- Derived from this study: PubMed 28135841Nakamura M, Fukukawa T, Kitagawa K, Nagai Y, Hosomi N, Minematsu K, Uchiyama S, Matsumoto M, Miyamoto Y; for J-STARS collaborators. Ten-year standardization of lipids and high-sensitivity C-reactive protein in a randomized controlled trial to assess the effects of statins on secondary stroke prevention: Japan Statin Treatment Against Recurrent Stroke. Ann Clin Biochem. 2018 Jan;55(1):128-135. doi: 10.1177/0004563217693651. Epub 2017 Jul 10.
- Japan Statin Treatment Against Recurrent Stroke (J-STARS) only in JapaneseLink provided by the sponsor.
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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.
Masayasu Matsumoto, MD, PhD principal investigator
Hiroshima University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pravastatin in people with Ischemic Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
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 4 inclusion and 8 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 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence Rate of Stroke and TIA (time frame: up to 5 years). 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 NCT00221104, which also lists 3 linked publications.
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 25 Jan 2018.