Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma
Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    atorvastatin ...
  • Study Participants

To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
Study design:

Multi-center, randomized, double-blind, placebo parallel controlled


Patients with chronic subdural hematoma (CSDH)

Sample size:

200, including an Atorvastatin-treated group of 100 patients and a control group of 100 subjects.
Study Started
Dec 31
Primary Completion
Apr 30
Study Completion
Sep 30
Last Update
Oct 25

Drug Atorvastatin

20 mg (every evening orally) for 8 weeks

Drug placebo

20 mg (every evening orally) for 8 weeks

placebo Placebo Comparator

placebo:20 mg (every evening orally) for 8 weeks

Atorvastatin Experimental

atorvastatin:20 mg (every evening orally) for 8 weeks


Inclusion Criteria:

Age ≥ 18 and <90 years old, male or female;
CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3;
Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;
Patients have never undergo surgery on the hematoma
Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

Allergic to the statin or its ingredients
Cerebral herniation might occur at any time;
Hematoma leads to herniation and warrants surgical operation.
Hematoma caused by tumors, blood and other known comorbidities;
Abnormal liver function
Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
Patients have been on oral Statin treatment for a long time.
Patients have been on oral Steroids treatment for a long time.
Participate in clinical trials in the past four weeks;
Pregnant or breastfeeding
Failure of completing the trial by poor compliance;
For any reason, the researchers believe that the case is not suitable for inclusion.
No Results Posted