Intracerebral HemorrhagePhase 2/3STATICNCT04857632
Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
A Phase 2/3 study testing Statin in people with Intracerebral Hemorrhage and Statins, run by Capital Medical University at 3 sites in China.
Trial summary
Brain injury after spontaneous intracerebral hemorrhage results from pathophysiologic responses in the brain parenchyma due to hematoma formation, release of clot components, and surrounding edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Statins
- What is being tested?
- Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesChina
- Study dates
- 6 Aug 2021to 30 Nov 2024
- Phase
- Phase 2/3
- 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
- Age of 18 years or older
- A clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brain CT scan
- Hematoma volume ≤40ml
- The first dose of statin can be given within 24h of intracerebral hemorrhage symptom onset (if the patient is randomized to statin group)
- Written informed consent
Who cannot join
- Presence of intraventricular hemorrhage or subarachnoid hemorrhage
- Planned surgical hematoma evacuation by open craniotomy prior to randomization (planned minimally invasive surgery is not a contraindication to enrollment)
- Suspected secondary intracerebral hemorrhage related to trauma, tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, Moyamoya disease, or venous sinus thrombosis
- Unable to swallow a statin pill and have contraindication to position a nasogastric tube
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≥2 × the upper limit of normal
- Known pregnancy, or positive pregnancy test, or breastfeeding
Show all 11Show fewer
- Other diseases or abnormalities that the investigator believed might compromise the patient's safety during the study
- Historical modified Rankin scale score ≥2
- Life expectancy of less than 7 days
- Participation in another clinical study within 30 days prior to screening for the present study
- Prior use of statins within 1 month before intracerebral hemorrhage
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Hebei Province Shunping County Hospital
Baoding
Shijie Bao
- Recruiting
Beijing Fengtai Youanmen Hospital
Beijing, Beijing Municipality, 100000
Daiquan Gao, M.D.
- Recruiting
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069
xunming ji, 861013120136877, jixunming@vip.163.com
About this study
Brain injury after spontaneous intracerebral hemorrhage results from pathophysiologic responses in the brain parenchyma due to hematoma formation, release of clot components, and surrounding edema. Inflammatory cascade activation in the perihematomal brain parenchyma has been implicated in the pathogenesis of secondary brain injury. Statins have been identified as a potential neuroprotective agent that targets the inflammatory response to intracerebral hemorrhage. In preclinical studies, statin treatment in animal intracerebral hemorrhage models has consistently demonstrated neuroprotective and recovery enhancement effects. Clinical investigations in humans reported better patient outcomes associated with statin use in patients with intracerebral hemorrhage, including reduced perihematomal edema, lower mortality rates, and improved functional outcomes.
- Conditions
- Intracerebral Hemorrhage, Statins
- Being tested
- Statin
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
atorvastatin 20mg per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Statins group | Experimental | Not described Receives: Drug: Statin |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perihemorrhagic edema to hematoma ratio
Measured: 7 days
Secondary outcomes (8)
Absolute perihematomal edema changes
Measured: 7 days
Hematoma resolution rate
Measured: 7 days
Absolute hematoma volume changes
Measured: 7 days
Ordinal distribution of modified Rankin scale scores
The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death).
Measured: 90 days
Proportion of patients with modified Rankin scale score 0-2
Measured: 90 days
Proportion of patients with modified Rankin scale score 0-3
Measured: 90 days
Rate of mortality
Measured: 30 dyas
National Institute of Health stroke scale
Scores on the National Institutes of Health Stroke Scale range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Measured: 7 days or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start6 Aug 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
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 Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857632
- Sponsor's protocol ID
- STATIC
- Acronym
- STATIC
- Status last verified
- Jan 2024
- First submitted
- 20 Apr 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gao D, Chu X, Zhang Y, Yan H, Niu L, Jiang X, Bao S, Ji X, Wu C. Statins for neuroprotection in spontaneous intracerebral haemorrhage (STATIC): protocol for a multicentre, prospective and randomised controlled trial. BMJ Open. 2024 Jun 21;14(6):e079879. doi: 10.1136/bmjopen-2023-079879.
PubMed 38908848
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT04857632
- Acronym / sponsor ID
- STATIC / STATIC
- Conditions
- Intracerebral Hemorrhage, Statins
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 23 Apr 2021 (actual)
- 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.
Brain injury after spontaneous intracerebral hemorrhage results from pathophysiologic responses in the brain parenchyma due to hematoma formation, release of clot components, and surrounding edema. Inflammatory cascade activation in the perihematomal brain parenchyma has been implicated in the pathogenesis of secondary brain injury. Statins have been identified as a potential neuroprotective agent that targets the inflammatory response to intracerebral hemorrhage. In preclinical studies, statin treatment in animal intracerebral hemorrhage models has consistently demonstrated neuroprotective and recovery enhancement effects. Clinical investigations in humans reported better patient outcomes associated with statin use in patients with intracerebral hemorrhage, including reduced perihematomal edema, lower mortality rates, and improved functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statins group | Experimental | Drug: Statin |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or older
- A clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brain CT scan
- Hematoma volume ≤40ml
- The first dose of statin can be given within 24h of intracerebral hemorrhage symptom onset (if the patient is randomized to statin group)
- Written informed consent
Key exclusion criteria (11 listed)
- Presence of intraventricular hemorrhage or subarachnoid hemorrhage
- Planned surgical hematoma evacuation by open craniotomy prior to randomization (planned minimally invasive surgery is not a contraindication to enrollment)
- Suspected secondary intracerebral hemorrhage related to trauma, tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, Moyamoya disease, or venous sinus thrombosis
- Unable to swallow a statin pill and have contraindication to position a nasogastric tube
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≥2 × the upper limit of normal
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 |
|---|---|---|
| Statinatorvastatin 20mg per day for 7 days | Drug | Statins group |
Primary outcome
Perihemorrhagic edema to hematoma ratio
Time frame: 7 days
8 secondary outcomes
Absolute perihematomal edema changes
Time frame: 7 days
Hematoma resolution rate
Time frame: 7 days
Absolute hematoma volume changes
Time frame: 7 days
Ordinal distribution of modified Rankin scale scores
Time frame: 90 days
Proportion of patients with modified Rankin scale score 0-2
Time frame: 90 days
Proportion of patients with modified Rankin scale score 0-3
Time frame: 90 days
Rate of mortality
Time frame: 30 dyas
National Institute of Health stroke scale
Time frame: 7 days or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 38908848Gao D, Chu X, Zhang Y, Yan H, Niu L, Jiang X, Bao S, Ji X, Wu C. Statins for neuroprotection in spontaneous intracerebral haemorrhage (STATIC): protocol for a multicentre, prospective and randomised controlled trial. BMJ Open. 2024 Jun 21;14(6):e079879. doi: 10.1136/bmjopen-2023-079879.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Statin in people with Intracerebral Hemorrhage and Statins, run by Capital Medical University at 3 sites in China.
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 5 inclusion and 11 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuanjie Wu, Dr. (18911366882, wuchuanjie8557@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perihemorrhagic edema to hematoma ratio (time frame: 7 days). 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 NCT04857632, 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 23 Jan 2024.