Ischemic StrokePhase 4ASSORTNCT02549846
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
A Phase 4 study testing Statin in people with Ischemic Stroke, run by Hyogo Medical University at 1 site in Japan.
Trial summary
Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2015to Mar 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the Informed consent will be acquired by the document.
- Age: 20 years of age or older.
- Gender: unquestioned
- hospitalization, outpatient: hospital
- Patients by MRI at the time of hospital transport, it has been confirmed diagnosed with cerebral infarction
- ingestible in within 24 hours after admission In the study treatment period, patients that can be defined treatment in this clinical study implementation plan
Who cannot join
- patients with a history of hypersensitivity to the treatment agent of the present study
- Patients acute hepatitis, chronic hepatitis acute exacerbation, liver cirrhosis, it is believed that the liver cancer, liver function jaundice or the like is reduced, or a biliary obstruction
- Patients suspected of being pregnant or pregnant
- Patients in the administration of the cyclosporine or telaprevir
- patients with moderate or severe renal impairment (SCr ≧ 2.5mg / dL or eGFR <30mg / dL)
- Patients who received a diagnosis of acute coronary syndrome within 6 months
Show all 10Show fewer
- valvular disease, atrial fibrillation, patients with atrial thrombus
- Patients familial hypercholesterolemia
- patient admission NIHSS score is greater than or equal to 3 is more than 20 or before the onset mRS score
- patients with other doctors deemed inappropriate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke
Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection
Read the detailed description
It is much more important in Japan than Western to improve the prognosis after stroke because the prevalence and mortality rate of stroke in Japan is about 3-4 times as those of acute myocardial infarction. Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection since most of previous studies with statins just showed the preventive effects from onset of primary or recurrent cerebral infarction.
- Conditions
- Ischemic Stroke
- Being tested
- Statin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called Atorvastatin, Pitavastain, Rosuvastatin
Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Acute Group | Active comparator | Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission Receives: Drug: Statin |
| Stable Group | Other | Not start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission. Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
Scale range from 0 [no symptom] to 6 [dead]
Measured: 12 weeks from stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionMar 2017
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyogo Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shionogi
- Responsible party
- Principal investigator, Shinichi Yoshimura, Hyogo Medical University
- Investigators
- Shinichi Yoshimura, Principal investigator, Hyogo collage of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549846
- Sponsor's protocol ID
- UMIN000021032
- Acronym
- ASSORT
- Status last verified
- Feb 2018
- First submitted
- 11 Aug 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoshimura S, Uchida K, Daimon T, Takashima R, Kimura K, Morimoto T; ASSORT Trial Investigator. Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient). Stroke. 2017 Nov;48(11):3057-3063. doi: 10.1161/STROKEAHA.117.017623. Epub 2017 Oct 13.
PubMed 29030478
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02549846
- Acronym / sponsor ID
- ASSORT / UMIN000021032
- Conditions
- Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Hyogo Medical UniversityUniversity, hospital or other
- Collaborators
- Shionogi
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Sep 2015 (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.
Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection
Detailed description
It is much more important in Japan than Western to improve the prognosis after stroke because the prevalence and mortality rate of stroke in Japan is about 3-4 times as those of acute myocardial infarction. Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection since most of previous studies with statins just showed the preventive effects from onset of primary or recurrent cerebral infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Group | Active comparator | Drug: StatinAtorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission |
| Stable Group | Other | Drug: StatinNot start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the Informed consent will be acquired by the document.
- Age: 20 years of age or older.
- Gender: unquestioned
- hospitalization, outpatient: hospital
- Patients by MRI at the time of hospital transport, it has been confirmed diagnosed with cerebral infarction
Key exclusion criteria (10 listed)
- patients with a history of hypersensitivity to the treatment agent of the present study
- Patients acute hepatitis, chronic hepatitis acute exacerbation, liver cirrhosis, it is believed that the liver cancer, liver function jaundice or the like is reduced, or a biliary obstruction
- Patients suspected of being pregnant or pregnant
- Patients in the administration of the cyclosporine or telaprevir
- patients with moderate or severe renal impairment (SCr ≧ 2.5mg / dL or eGFR <30mg / dL)
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 |
|---|---|---|
| StatinAlso: Atorvastatin, Pitavastain, RosuvastatinRandomized controlled trial of early versus late statin therapy in patients with ischemic stroke | Drug | Acute Group, Stable Group |
Primary outcome
modified Rankin Scale
Time frame: 12 weeks from stroke onset
Scale range from 0 [no symptom] to 6 [dead]
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 27 Feb 2018.
- Derived from this study: PubMed 29030478Yoshimura S, Uchida K, Daimon T, Takashima R, Kimura K, Morimoto T; ASSORT Trial Investigator. Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient). Stroke. 2017 Nov;48(11):3057-3063. doi: 10.1161/STROKEAHA.117.017623. Epub 2017 Oct 13.
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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.
Shinichi Yoshimura principal investigator
Hyogo collage of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Statin in people with Ischemic Stroke, run by Hyogo Medical University 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 6 inclusion and 10 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 27 Feb 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 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?
modified Rankin Scale (time frame: 12 weeks from stroke onset). 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 NCT02549846, 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 27 Feb 2018.