Statins for Treatment of Primary Intracerebral Hemorrhage
STOP ICH
Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)
1 other identifier
interventional
264
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2023
CompletedFirst Submitted
Initial submission to the registry
July 20, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 28, 2025
July 1, 2025
3.4 years
July 20, 2025
July 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
90 ± 7 days
Secondary Outcomes (7)
Functional independence
90 ± 7 days
Ordinal distribution of mRS
90 ± 7 days
Changes in hematoma volume from baseline to 24 ± 12 hours
24 ± 12 hours
Changes in hematoma volume from baseline to 7 ± 1 days
7 ± 1 days
Changes in hematoma volume from 24 ± 12 hours to 7 ± 1 days
between 24 ± 12 hours and 7 ± 1 days
- +2 more secondary outcomes
Other Outcomes (3)
Recurrent intracerebral hemorrhage
90 ± 7 days
All cause mortality
90 ± 7 days
Any adverse event/serious adverse event
90 ± 7 days
Study Arms (2)
Atorvastatin Treatment plus Best Medical Treatment
EXPERIMENTALPatients in this group will receive atorvastatin treatment plus best medical treatment.
Best Medical Treatment
ACTIVE COMPARATORPatients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Interventions
Atorvastatin 20 mg once daily for 21 days.
Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Anqing First People's Hospital of Anhui Province
Anqing, Anhui, China
Fuyang City Sixth People's Hospital
Fuyang, Anhui, China
Fuyang Hospital of Anhui Medical University
Fuyang, Anhui, China
Fuyang People's Hospital
Fuyang, Anhui, China
Hefei Eighth People's Hospital
Hefei, Anhui, China
Hefei First People's Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Huainan Xinhua Hospital
Huainan, Anhui, China
The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital)
Huainan, Anhui, China
Huoqiu First People's Hospital
Lu'an, Anhui, China
Shucheng People's Hospital
Lu'an, Anhui, China
Si County People's Hospital
Suzhou, Anhui, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Xihua County People's Hospital
Zhoukou, Henan, China
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
Yancheng First People's Hospital
Yancheng, Jiangsu, China
Chengdu Western Hospital
Chengdu, Sichuan, China
Panzhihua Central Hospital
Panzhihua, Sichuan, China
Dazhu County People's Hospital
Dazhou, Sizhuan, China
The Third Affiliated Hospital of Chong Qing Medical University
Chongqing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 20, 2025
First Posted
July 28, 2025
Study Start
May 6, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 28, 2025
Record last verified: 2025-07