Cerebrovascular DisordersSTOP ICHNCT07088250
Statins for Treatment of Primary Intracerebral Hemorrhage
A study testing Atorvastatin Treatment and Best Medical Treatment in people with Cerebrovascular Disorders and Intracranial Hemorrhages, run by The Second Hospital of Anhui Medical University at 22 sites in China.
Trial summary
The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Disorders, Intracranial Hemorrhages, Intracranial Hemorrhage
- What is being tested?
- Atorvastatin Treatment and Best Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 22 sitesChina
- Study dates
- 6 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);
- Age 18-80 years;
- Hematoma located in the supratentorial region;
- Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;
- Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;
- Glasgow Coma Scale (GCS) score ≥9;
- Baseline hematoma volume of 5-35 mL;
- Signed informed consent obtained.
Who cannot join
- ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;
- Patients who have undergone or are scheduled for immediate surgical intervention;
- Pregnancy or lactation;
- Use of oral anticoagulants within 1 month prior to symptom onset;
- Pre-stroke mRS >1;
- Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis;
- Known terminal illness with a pre-stroke life expectancy of less than three months, or patients with planned withdrawal of care.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Anqing First People's Hospital of Anhui Province
Anqing, Anhui
Liangbing Zhang, 15155493196, liangbingzhang@163.com
- Recruiting
Chengdu Western Hospital
Chengdu, Sichuan
Songge Zhang, 13708239928, 920992308@qq.com
- Recruiting
The First People's Hospital of Chenzhou
Chenzhou, Hunan
Wei Xu, 18873586687, 364244173@qq.com
- Recruiting
The Third Affiliated Hospital of Chong Qing Medical University
Chongqing
Jin Cheng, 023-89011876, 1096497150@qq.com
- Recruiting
Dazhu County People's Hospital
Dazhou, Sizhuan
Sheng Zhu, 08186096301, 37177343@qq.com
- Recruiting
Fuyang City Sixth People's Hospital
Fuyang, Anhui
Dawei Han, 13855896794, handawei980047@sina.com
- Recruiting
Fuyang Hospital of Anhui Medical University
Fuyang, Anhui
Zongjin Yun, 13955896560, yzjlove521@sohu.com
- Recruiting
Fuyang People's Hospital
Fuyang, Anhui
Zhibo Gao, 15215689898, gzb688@126.com
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Hongsheng Liang, 13339318226, lianghongsheng@hrbmu.edu.cn
- Recruiting
Hefei Eighth People's Hospital
Hefei, Anhui
Shumei Wu, 13856597670, elfinwsm@sina.com
- Recruiting
Hefei First People's Hospital
Hefei, Anhui
Li Ye, 0551-62183884, yeliaa@126.com
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
Qi Li, +8618623511778, qili_md@126.com
Qi Li
- Recruiting
Huainan Xinhua Hospital
Huainan, Anhui
Ke He, 15255429870, 765188944@qq.com
- Recruiting
The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital)
Huainan, Anhui
Chuanqing Yu, 18949669880, yuchuanqin1967@163.com
- Recruiting
Kaifeng Central Hospital
Kaifeng, Henan
Xinsheng Han, 18603780505, hansong2008@126.com
- Recruiting
Huoqiu First People's Hospital
Lu'an, Anhui
Weixiang Tian, 13305648455, 1015685276@qq.com
- Recruiting
Shucheng People's Hospital
Lu'an, Anhui
Jianshang Wen, 13956145900, wjs916@126.com
- Recruiting
Panzhihua Central Hospital
Panzhihua, Sichuan
Wenyu Zhang, 0812-2238461, 1006298426@qq.com
- Recruiting
Si County People's Hospital
Suzhou, Anhui
Xiaoqiang Wu, 05577010396, Wxq121@163.com
- Recruiting
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei
Jincheng Liu, 0710-3444963, liujincheng004@163.com
- Recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu
Guojun He, 15251131959, heguojun@ycsyy.com
- Recruiting
Xihua County People's Hospital
Zhoukou, Henan
Chaoqun Li, 0394-2551384, 568258977@qq.com
About this study
Official title: Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)
The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset.
Read the detailed description
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) clinical trial aimed at evaluating the efficacy and safety of atorvastatin in patients with spontaneous intracerebral hemorrhage (ICH). Eligible participants include adults aged 18 to 80 years presenting with spontaneous ICH who are enrolled within 3 to 24 hours from symptom onset or the last known well time, provided they meet all inclusion criteria and no exclusion criteria. A total of 264 patients will be randomized in a 1:1 ratio into two treatment arms: the control group, receiving best medical treatment (BMT) in accordance with current ICH guidelines, and the experimental group, receiving BMT plus atorvastatin at a dosage of 20 mg once daily for 21 consecutive days. The primary objective is to determine whether atorvastatin improves clinical outcomes in patients with ICH. The primary efficacy endpoint is the proportion of patients with a poor functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 4 to 6.
- Conditions
- Cerebrovascular Disorders, Intracranial Hemorrhages, Intracranial Hemorrhage, Intracerebral Haemorrhage
- Being tested
- Atorvastatin Treatment, Best Medical Treatment
- Keywords
- Intracerebral hemorrhage, Treatment, Atorvastatin, Outcome
- Medical subject headings
- Cerebrovascular Disorders, Intracranial Hemorrhages, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin TreatmentDrug
Atorvastatin 20 mg once daily for 21 days.
Best Medical TreatmentOther
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin Treatment plus Best Medical Treatment | Experimental | Patients in this group will receive atorvastatin treatment plus best medical treatment. Receives: Drug: Atorvastatin Treatment; Other: Best Medical Treatment |
| Best Medical Treatment | Active comparator | Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH. Receives: Other: Best Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor functional outcome
The proportion of poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Measured: 90 ± 7 days
Secondary outcomes (7)
Functional independence
The proportion of functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
Measured: 90 ± 7 days
Ordinal distribution of mRS
Ordinal distribution of the modified Rankin Scale (mRS) at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes
Measured: 90 ± 7 days
Changes in hematoma volume from baseline to 24 ± 12 hours
Absolute and relative changes in hematoma volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 24 ± 12 hours post-baseline.
Measured: 24 ± 12 hours
Changes in hematoma volume from baseline to 7 ± 1 days
Absolute and relative changes in hematoma volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 7 ± 1 days post-baseline.
Measured: 7 ± 1 days
Changes in hematoma volume from 24 ± 12 hours to 7 ± 1 days
Absolute and relative changes in hematoma volume, measured as the difference between 24 ± 12 hours CT scan and 7 ± 1 days CT scan.
Measured: between 24 ± 12 hours and 7 ± 1 days
Changes in perihematomal edema (PHE) volume from baseline to 7 ± 1 days
Changes in PHE volume, measured as the difference between baseline CT scan and follow-up CT scan performed at 7 ± 1 days post-baseline.
Measured: 7 ± 1 days
Changes in perihematomal edema (PHE) volume from 24 ± 12 hours to 7 ± 1 days
Changes in PHE volume, measured as the difference between 24 ± 12 hours CT scan and 7 ± 1 days CT scan
Measured: 7 ± 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start6 May 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Li, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088250
- Sponsor's protocol ID
- YX2023-041(F1)
- Acronym
- STOP ICH
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)
- ClinicalTrials.gov ID
- NCT07088250
- Acronym / sponsor ID
- STOP ICH / YX2023-041(F1)
- Conditions
- Cerebrovascular Disorders, Intracranial Hemorrhages, Intracranial Hemorrhage, Intracerebral Haemorrhage
- Keywords
- Intracerebral hemorrhage, Treatment, Atorvastatin, Outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (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.
The STOP ICH trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the efficacy and safety of atorvastatin in patients with intracerebral hemorrhage (ICH) presenting within 3 to 24 hours of symptom onset.
Detailed description
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) clinical trial aimed at evaluating the efficacy and safety of atorvastatin in patients with spontaneous intracerebral hemorrhage (ICH). Eligible participants include adults aged 18 to 80 years presenting with spontaneous ICH who are enrolled within 3 to 24 hours from symptom onset or the last known well time, provided they meet all inclusion criteria and no exclusion criteria. A total of 264 patients will be randomized in a 1:1 ratio into two treatment arms: the control group, receiving best medical treatment (BMT) in accordance with current ICH guidelines, and the experimental group, receiving BMT plus atorvastatin at a dosage of 20 mg once daily for 21 consecutive days. The primary objective is to determine whether atorvastatin improves clinical outcomes in patients with ICH. The primary efficacy endpoint is the proportion of patients with a poor functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 4 to 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin Treatment plus Best Medical Treatment | Experimental | Drug: Atorvastatin Treatment, Other: Best Medical TreatmentPatients in this group will receive atorvastatin treatment plus best medical treatment. |
| Best Medical Treatment | Active comparator | Other: Best Medical TreatmentPatients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);
- Age 18-80 years;
- Hematoma located in the supratentorial region;
- Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;
- Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;
Key exclusion criteria (7 listed)
- ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;
- Patients who have undergone or are scheduled for immediate surgical intervention;
- Pregnancy or lactation;
- Use of oral anticoagulants within 1 month prior to symptom onset;
- Pre-stroke mRS >1;
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 |
|---|---|---|
| Atorvastatin TreatmentAtorvastatin 20 mg once daily for 21 days. | Drug | Atorvastatin Treatment plus Best Medical Treatment |
| Best Medical TreatmentPatients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH. | Other | Atorvastatin Treatment plus Best Medical Treatment, Best Medical Treatment |
Primary outcome
Poor functional outcome
Time frame: 90 ± 7 days
The proportion of poor functional outcome, defined as a modified Rankin Scale (mRS) score of 4-6 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
7 secondary outcomes
Functional independence
Time frame: 90 ± 7 days
Ordinal distribution of mRS
Time frame: 90 ± 7 days
Changes in hematoma volume from baseline to 24 ± 12 hours
Time frame: 24 ± 12 hours
Changes in hematoma volume from baseline to 7 ± 1 days
Time frame: 7 ± 1 days
Changes in hematoma volume from 24 ± 12 hours to 7 ± 1 days
Time frame: between 24 ± 12 hours and 7 ± 1 days
Changes in perihematomal edema (PHE) volume from baseline to 7 ± 1 days
Time frame: 7 ± 1 days
Changes in perihematomal edema (PHE) volume from 24 ± 12 hours to 7 ± 1 days
Time frame: 7 ± 1 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin Treatment and Best Medical Treatment in people with Cerebrovascular Disorders and Intracranial Hemorrhages, run by The Second Hospital of Anhui Medical University at 22 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Li (+8618623511778, qili_md@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor functional outcome (time frame: 90 ± 7 days). 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 28 Jul 2025.