Statins for Treatment of Primary Intracerebral Hemorrhage

NCT ID: NCT07088250

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-06

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Cerebrovascular Disorders Intracranial Hemorrhages Intracranial Hemorrhage Intracerebral Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Atorvastatin Treatment plus Best Medical Treatment

Patients in this group will receive atorvastatin treatment plus best medical treatment.

Group Type EXPERIMENTAL

Atorvastatin Treatment

Intervention Type DRUG

Atorvastatin 20 mg once daily for 21 days.

Best Medical Treatment

Intervention Type OTHER

Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.

Best Medical Treatment

Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.

Group Type ACTIVE_COMPARATOR

Best Medical Treatment

Intervention Type OTHER

Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.

Interventions

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Atorvastatin Treatment

Atorvastatin 20 mg once daily for 21 days.

Intervention Type DRUG

Best Medical Treatment

Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qi Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anqing First People's Hospital of Anhui Province

Anqing, Anhui, China

Site Status RECRUITING

Fuyang City Sixth People's Hospital

Fuyang, Anhui, China

Site Status RECRUITING

Fuyang Hospital of Anhui Medical University

Fuyang, Anhui, China

Site Status RECRUITING

Fuyang People's Hospital

Fuyang, Anhui, China

Site Status RECRUITING

Hefei Eighth People's Hospital

Hefei, Anhui, China

Site Status RECRUITING

Hefei First People's Hospital

Hefei, Anhui, China

Site Status RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Huainan Xinhua Hospital

Huainan, Anhui, China

Site Status RECRUITING

The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital)

Huainan, Anhui, China

Site Status RECRUITING

Huoqiu First People's Hospital

Lu'an, Anhui, China

Site Status RECRUITING

Shucheng People's Hospital

Lu'an, Anhui, China

Site Status RECRUITING

Si County People's Hospital

Suzhou, Anhui, China

Site Status RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Kaifeng Central Hospital

Kaifeng, Henan, China

Site Status RECRUITING

Xihua County People's Hospital

Zhoukou, Henan, China

Site Status RECRUITING

Xiangyang Hospital of Traditional Chinese Medicine

Xiangyang, Hubei, China

Site Status RECRUITING

The First People's Hospital of Chenzhou

Chenzhou, Hunan, China

Site Status RECRUITING

Yancheng First People's Hospital

Yancheng, Jiangsu, China

Site Status RECRUITING

Chengdu Western Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Panzhihua Central Hospital

Panzhihua, Sichuan, China

Site Status RECRUITING

Dazhu County People's Hospital

Dazhou, Sizhuan, China

Site Status RECRUITING

The Third Affiliated Hospital of Chong Qing Medical University

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi Li

Role: CONTACT

+8618623511778

Facility Contacts

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Liangbing Zhang

Role: primary

15155493196

Dawei Han

Role: primary

13855896794

Zongjin Yun

Role: primary

13955896560

Zhibo Gao

Role: primary

15215689898

Shumei Wu

Role: primary

13856597670

Li Ye

Role: primary

0551-62183884

Qi Li

Role: primary

+8618623511778

Ke He

Role: primary

15255429870

Chuanqing Yu

Role: primary

18949669880

Weixiang Tian

Role: primary

13305648455

Jianshang Wen

Role: primary

13956145900

Xiaoqiang Wu

Role: primary

05577010396

Hongsheng Liang

Role: primary

13339318226

Xinsheng Han

Role: primary

18603780505

Chaoqun Li

Role: primary

0394-2551384

Jincheng Liu

Role: primary

0710-3444963

Wei Xu

Role: primary

18873586687

Guojun He

Role: primary

15251131959

Songge Zhang

Role: primary

13708239928

Wenyu Zhang

Role: primary

0812-2238461

Sheng Zhu

Role: primary

08186096301

Jin Cheng

Role: primary

023-89011876

Other Identifiers

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YX2023-041(F1)

Identifier Type: -

Identifier Source: org_study_id

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