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
1 other identifier
interventional
200
1 country
31
Brief Summary
To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 25, 2016
February 1, 2016
2.3 years
August 7, 2013
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hematoma Reduced Amount.
The primary efficacy endpoint: hematoma reduced amount. Outcome Measures: all patients underwent head CT (plain scan) before treatment, and check on 8 weeks during treatment (at the end)
Check on 8 weeks during treatment (at the end)
Secondary Outcomes (4)
The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Changes of neurological symptoms and signs
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Changes of routine blood test and coagulation results
0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Hematoma Reduced Amount
4 weeks during treatment, in the follow-up in 12 and 24 weeks.
Study Arms (2)
Atorvastatin
EXPERIMENTALatorvastatin：20 mg (every evening orally) for 8 weeks
placebo
PLACEBO COMPARATORplacebo:20 mg (every evening orally) for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Beijing tiantan hospital
Beijing, Beijing Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Chinese PLA General Hospital
Beijing, China
Peking union medical college hospital
Beijing, China
Cangzhou centerl hospital
Cangzhou, China
Xiangya hospital central southe university
Changsha, China
Southwest hospital
Chongqing, China
West china hospital
Chongqing, China
The first affiliated hospital of Fujian medical university
Fuzhou, China
Nanfang hospital
Guangzhou, China
First Affiliated Hospital of Harbin Medical University
Haerbing, China
Hainan general hospital
Haikou, China
117 Hospital of People's Liberation Army
Hangzhou, China
The second Affiliated hospital of zhejiang university school of medicine
Hangzhou, China
Anhui provincial hospital
Hefei, China
Inner mongolia people's hospital
Hohehot, China
Qilu hospital of shandong university
Jinan, China
Linyi People's Hospital
Linyi, China
Jiangsu province hospital
Nanjing, China
Ordos Central Hospital
Ordos, China
Changzheng Hospital
Shanghai, China
Huashan hospital
Shanghai, China
The second hospital of Hebei medical university
Shijiazhuang, China
The first hospital of Shanxi medical university
Taiyuan, China
Tongji hospital
Wuhan, China
Tangdu hospital
Xi'an, China
Xijing Hospital
Xi'an, China
Prince of Wales Hospital
Xianggang, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China
General Hospital of Ningxia Medical University
Yinchuan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Related Publications (3)
Wang D, Tian Y, Wei H, Gao C, Fan Y, Yang G, Quan W, Huang J, Yue S, Zhang J, Jiang R. Risk Factor Analysis of the Conservative Treatment in Chronic Subdural Hematomas: A Substudy of the ATOCH Trial. Adv Ther. 2022 Apr;39(4):1630-1641. doi: 10.1007/s12325-022-02057-w. Epub 2022 Feb 8.
PMID: 35133631DERIVEDJiang R, Zhao S, Wang R, Feng H, Zhang J, Li X, Mao Y, Yuan X, Fei Z, Zhao Y, Yu X, Poon WS, Zhu X, Liu N, Kang D, Sun T, Jiao B, Liu X, Yu R, Zhang J, Gao G, Hao J, Su N, Yin G, Zhu X, Lu Y, Wei J, Hu J, Hu R, Li J, Wang D, Wei H, Tian Y, Lei P, Dong JF, Zhang J. Safety and Efficacy of Atorvastatin for Chronic Subdural Hematoma in Chinese Patients: A Randomized ClinicalTrial. JAMA Neurol. 2018 Nov 1;75(11):1338-1346. doi: 10.1001/jamaneurol.2018.2030.
PMID: 30073290DERIVEDJiang R, Wang D, Poon WS, Lu YC, Li XG, Zhao SG, Wang RZ, You C, Yuan XR, Zhang JM, Feng H, Fei Z, Yu XG, Zhao YL, Hu J, Kang DZ, Yu RT, Gao GD, Zhu XD, Sun T, Hao JH, Liu XZ, Su N, Yue SY, Zhang JN. Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial. Trials. 2015 Nov 18;16:528. doi: 10.1186/s13063-015-1045-y.
PMID: 26581842DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ning jian zhang, MD, PhD
Tianjin Medical University General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2013
First Posted
December 31, 2013
Study Start
December 1, 2013
Primary Completion
April 1, 2016
Study Completion
September 1, 2016
Last Updated
October 25, 2016
Record last verified: 2016-02