Using statins to protect the brain after bleeding in the brain

Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage

This study is testing if giving statins to people who have had bleeding in the brain can help protect their brain and improve their recovery.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 3 sites (Beijing, Beijing and 2 other locations)
• Trial ID: NCT04857632 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of statins as a neuroprotective treatment for patients who have experienced spontaneous intracerebral hemorrhage. The study aims to determine if administering statins within 24 hours of symptom onset can reduce brain injury and improve recovery outcomes. Participants will be monitored for changes in perihematomal edema, mortality rates, and functional recovery. The trial includes both Phase 2 and Phase 3 evaluations to assess the efficacy and safety of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of supratentorial intracerebral hemorrhage and a hematoma volume of 40ml or less.

Not a fit: Patients with intraventricular hemorrhage, planned surgical intervention, or contraindications to statin use may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and reduce complications for patients suffering from intracerebral hemorrhage.

How similar studies have performed: Previous studies have shown promising results with statin use in similar contexts, indicating potential for positive outcomes.

Eligibility criteria

Inclusion Criteria:

* Age of 18 years or older
* A clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brain CT scan
* Hematoma volume ≤40ml
* The first dose of statin can be given within 24h of intracerebral hemorrhage symptom onset (if the patient is randomized to statin group)
* Written informed consent

Exclusion Criteria:

* Presence of intraventricular hemorrhage or subarachnoid hemorrhage
* Planned surgical hematoma evacuation by open craniotomy prior to randomization (planned minimally invasive surgery is not a contraindication to enrollment)
* Suspected secondary intracerebral hemorrhage related to trauma, tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, Moyamoya disease, or venous sinus thrombosis
* Unable to swallow a statin pill and have contraindication to position a nasogastric tube
* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≥2 × the upper limit of normal
* Known pregnancy, or positive pregnancy test, or breastfeeding
* Other diseases or abnormalities that the investigator believed might compromise the patient's safety during the study
* Historical modified Rankin scale score ≥2
* Life expectancy of less than 7 days
* Participation in another clinical study within 30 days prior to screening for the present study
* Prior use of statins within 1 month before intracerebral hemorrhage

Where this trial is running

Beijing, Beijing and 2 other locations

• Beijing Fengtai Youanmen Hospital — Beijing, Beijing, China (Recruiting)
• Xuan Wu Hospital，Capital Medical University — Beijing, Beijing, China (Recruiting)
• Hebei Province Shunping County Hospital — Baoding, China (Recruiting)

Study contacts

• Study coordinator: Chuanjie Wu, Dr.

Conditions Intracerebral Hemorrhage; Statins