Trial | NCT02024373  Report issue

Title

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

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    atorvastatin ...

  • Study Participants

    200
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

Subjects:

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
2013
Primary Completion
Apr 30
2016
Study Completion
Sep 30
2016
Last Update
Oct 25
2016
Estimate

Drug Atorvastatin

20 mg (every evening orally) for 8 weeks

Drug placebo

20 mg (every evening orally) for 8 weeks

Atorvastatin Experimental

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

placebo Placebo Comparator

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

Criteria 

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