Trials / Recruiting
RecruitingNCT07088250
Statins for Treatment of Primary Intracerebral Hemorrhage
Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- Sponsor
- The Second Hospital of Anhui Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atorvastatin Treatment | Atorvastatin 20 mg once daily for 21 days. |
| OTHER | Best Medical Treatment | Patients in this group will receive best medical treatments in accordance with the guideline-directed management for ICH. |
Timeline
- Start date
- 2023-05-06
- Primary completion
- 2026-09-30
- Completion
- 2026-12-31
- First posted
- 2025-07-28
- Last updated
- 2025-07-28
Locations
22 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07088250. Inclusion in this directory is not an endorsement.