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Recruiting NCT07088250

Statins for Treatment of Primary Intracerebral Hemorrhage

No phase Interventional Cerebrovascular Disorders Intracranial Hemorrhages Intracranial Hemorrhage Intracerebral Haemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atorvastatin Treatment, Best Medical Treatment.
Who it may be relevant to
Registry conditions: Cerebrovascular Disorders, Intracranial Hemorrhages, Intracranial Hemorrhage, Intracerebral Haemorrhage. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Poor functional outcome [Time frame: 90 ± 7 days]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 22 centers
  • Anqing First People's Hospital of Anhui Province — Anqing
  • Fuyang City Sixth People's Hospital — Fuyang
  • Fuyang Hospital of Anhui Medical University — Fuyang
  • Fuyang People's Hospital — Fuyang
  • Hefei Eighth People's Hospital — Hefei
  • Hefei First People's Hospital — Hefei
  • The Second Hospital of Anhui Medical University — Hefei
  • Huainan Xinhua Hospital — Huainan
  • … and 14 more centers

Identifiers

NCT: NCT07088250 · YX2023-041(F1)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗