Skip to content

The efficacy and safety of Atorvastatin on intracerebral hematoma: A randomized, double-blind, placebo-controlled trial

The efficacy and safety of Atorvastatin on intracerebral hematoma: A randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055889
Enrollment
Unknown
Registered
2022-01-22
Start date
2022-01-30
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hematoma

Interventions

ATO:Atorvastatin 20mg 8 weeks+standard treatment of ICH
Control :Standard treatment of ICH

Sponsors

General Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over, male and female; 2. GCS > 8, head CT or MRI clearly shows spontaneous, solitary, localized intracerebral hematoma in the basal ganglia (Patients with hematoma volume of 10ml-40ml who were unable to tolerate surgery or refused surgical treatment due to poor function of large organs); 3. Hematoma occurs less than 48 hours; 4. Patients with no risk of brain hernia are suitable for non-surgical treatment; 5. The patient has been acknowledge of the nature of the study, and volunteer to participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patient who is allergic to the drug contents; 2. Within 72 hours, required surgical treatment due to the increased bleeding; 3. Breaking into the ventricle or communicating with the subarachnoid space and cerebrospinal fluid circulation; 4. Hematomas caused herniation or can be highly suspected of causing herniation, non-surgical incurable; 5. Hematoma is caused by tumors, blood diseases, suspected vascular amyloidosis, arteriovenous structural lesions such as aneurysms, arteriovenous malformations and various sinus fistulas; 6. Patients with previous cerebral hemorrhage and neurological dysfunction caused by cerebral infarction; 7. Obvious abnormal function of liver and kidney before the trial, affecting the overall prognosis of patient; 8. Patients with a history of oral or allergic statins during the first 2 weeks of the trial; 9. Use of antiplatelet drugs such as aspirin or warfarin in the last 4 weeks; 10. Patient who has participated in other drug clinical trials in 4 weeks; 11. Pregnancy or lactation patients; 12. Patient with poor compliance, and cannot complete the study according to the research program; 13. The researcher finds there is any situation that is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
mRS score;

Secondary

MeasureTime frame
The decrease of hematoma;The rate of operation caused by the expansion of hematoma;ADL-BI score;mRS;

Countries

China

Contacts

Public ContactJiang Rongcai

Tianjin Medical University General Hospital

jiang116216@163.com+86 13672116556

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026