IschemicPhase 4AISNCT02643784
Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
A Phase 4 study testing Rosuvastatin in people with Ischemic, run by RenJi Hospital.
Trial summary
This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Ischemic
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jul 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 to 75 years old patients;
- Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;
- Time from symptom onset to take the study assigned medication is within 24 hours;
- Statin naïve or discontinued at least 3 month before stroke onset;
- First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;
- Moderate neurological deficit with baseline NIHSS scoring from 4-20;
- MRI scans （T1W1、T2W2、T2Flair、DWI、SWI）accomplished from 12 to 48 hours after the onset;
- Consent form signed.
Who cannot join
- -
- Any of the following is regarded as a criterion for exclusion from the study:
- Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;
- Hemorrhagic transformation or intracranial hemorrhage on baseline MRI. MRI performed between 12-48 hours after the onset, if MRI provides evidences which met with the exclusion criteria, the patients will be excluded from the study;
- Any circumstances under which MRI scans can't be performed;
- Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;
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- Comatose with NIHSS 1a>1;
- Medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse;
- Suitable for rt-Plasminogen Activator thrombolysis treatment;
- Receiving medication with possible neuroprotective functions after stroke onset;
- Currently take steroids therapy;
- Diagnosed with malignancy within 5 years;
- Patients with myopathy or serum creatine kinase > 3 times the upper limit of normal not caused by myocardial injury;
- Severe renal function damage (eGFR<30);
- Concurrent use ciclosporin;
- A history of hypersensitivity of statins and other severe complication;
- Child-bearing women ;
- Patients who are or may be pregnant;
- Other conditions under which patients not pertinent to attend the study as judged by the investigators.
About this study
This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.
Read the detailed description
This is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.
- Conditions
- Ischemic
- Being tested
- Rosuvastatin, Control
- Keywords
- acute ischemic stroke
- Medical subject headings
- Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called RSV
Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days.
Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.
ControlOther
Randomized Treatment Period (Day 1 through Day 14):
No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin study drug will be supplied in tablets (10 mg), assigned dose to be taken orally, once daily by subjects randomized to receive rosuvastatin 20 mg(take rosuvastatin until 14th day). Receives: Drug: Rosuvastatin; Other: Control |
| Control | No intervention | Control group(don't take rosuvastatin until 14th day), as directed by the study physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Measured: 0-14d
Secondary outcomes (5)
Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Measured: 0-14d
Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke
Measured: 0-14d
The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group
Measured: 14-90d
The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group
Measured: 14-90d
The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group
Measured: 0-14d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemicStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643784
- Sponsor's protocol ID
- ESR-14-10028
- Acronym
- AIS
- Status last verified
- Dec 2015
- First submitted
- 16 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02643784
- Acronym / sponsor ID
- AIS / ESR-14-10028
- Conditions
- Ischemic
- Keywords
- acute ischemic stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 31 Dec 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.
This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.
Detailed description
This is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin, Other: ControlRosuvastatin study drug will be supplied in tablets (10 mg), assigned dose to be taken orally, once daily by subjects randomized to receive rosuvastatin 20 mg(take rosuvastatin until 14th day). |
| Control | No intervention | –Control group(don't take rosuvastatin until 14th day), as directed by the study physician. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 45 to 75 years old patients;
- Stroke involving the vascular territory of the middle cerebral artery (MCA) as judged by clinical and MRI evidences;
- Time from symptom onset to take the study assigned medication is within 24 hours;
- Statin naïve or discontinued at least 3 month before stroke onset;
- First ever stroke or mild sequelae (with modified Rankin Score 0-1) before the index event;
Key exclusion criteria (19 listed)
- -
- Stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and MRI evidences;
- Hemorrhagic transformation or intracranial hemorrhage on baseline MRI. MRI performed between 12-48 hours after the onset, if MRI provides evidences which met with the exclusion criteria, the patients will be excluded from the study;
- Any circumstances under which MRI scans can't be performed;
- Evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc;
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 |
|---|---|---|
| RosuvastatinAlso: RSVRandomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day. | Drug | Rosuvastatin |
| ControlRandomized Treatment Period (Day 1 through Day 14): No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day. | Other | Rosuvastatin |
Primary outcome
Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Time frame: 0-14d
5 secondary outcomes
Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke
Time frame: 0-14d
Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke
Time frame: 0-14d
The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group
Time frame: 14-90d
The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group
Time frame: 14-90d
The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group
Time frame: 0-14d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Ischemic, run by RenJi Hospital.
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 8 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke (time frame: 0-14d). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2015.