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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Experimental | atorvastatin：20 mg (every evening orally) for 8 weeks |
|
| placebo | Placebo Comparator | placebo:20 mg (every evening orally) for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 20 mg (every evening orally) for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ning jian zhang, MD, PhD | Tianjin Medical University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tiantan hospital | Beijing | Beijing Municipality | China | |||
| Tianjin Medical University General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35133631 | Derived | 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. | |
| 30073290 | Derived | Jiang 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. |
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| placebo |
| Drug |
20 mg (every evening orally) for 8 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. |
| 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 |
| 26581842 | Derived | Jiang 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. |
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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