Chronic Subdural HematomaPhase 2NCT02024373
Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma
A Phase 2 study testing Atorvastatin in people with Chronic Subdural Hematoma, run by Oriental Neurosurgery Evidence-Based-Study Team at 31 sites in China.
Trial summary
To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 31 sitesChina
- Study dates
- Dec 2013to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
Beijing tiantan hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing
Peking union medical college hospital
Beijing
Cangzhou centerl hospital
Cangzhou
Xiangya hospital central southe university
Changsha
Southwest hospital
Chongqing
West china hospital
Chongqing
The first affiliated hospital of Fujian medical university
Fuzhou
Nanfang hospital
Guangzhou
First Affiliated Hospital of Harbin Medical University
Haerbing
Hainan general hospital
Haikou
117 Hospital of People's Liberation Army
Hangzhou
The second Affiliated hospital of zhejiang university school of medicine
Hangzhou
Anhui provincial hospital
Hefei
Inner mongolia people's hospital
Hohehot
Qilu hospital of shandong university
Jinan
Linyi People's Hospital
Linyi
Jiangsu province hospital
Nanjing
Ordos Central Hospital
Ordos
Changzheng Hospital
Shanghai
Huashan hospital
Shanghai
The second hospital of Hebei medical university
Shijiazhuang
The first hospital of Shanxi medical university
Taiyuan
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tongji hospital
Wuhan
Tangdu hospital
Xi'an
Xijing Hospital
Xi'an
Prince of Wales Hospital
Xianggang
The Affiliated Hospital of Xuzhou Medical College
Xuzhou
General Hospital of Ningxia Medical University
Yinchuan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma
To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
Read the detailed description
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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Atorvastatin, placebo
- Keywords
- chronic subdural hematoma, Atorvastatin, oral administration therapy
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
20 mg (every evening orally) for 8 weeks
placeboDrug
20 mg (every evening orally) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | atorvastatin：20 mg (every evening orally) for 8 weeks Receives: Drug: Atorvastatin |
| placebo | Placebo comparator | placebo:20 mg (every evening orally) for 8 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Changes of neurological symptoms and signs
Measured: 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
Measured: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Hematoma Reduced Amount
Measured: 4 weeks during treatment, in the follow-up in 12 and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning jian zhang, MD, PhD, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024373
- Sponsor's protocol ID
- CSDH2013
- Status last verified
- Feb 2016
- First submitted
- 7 Aug 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35133631Jiang 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.
PubMed 30073290Jiang 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.
PubMed 26581842
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT02024373
- Acronym / sponsor ID
- CSDH2013
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, Atorvastatin, oral administration therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study TeamUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatinatorvastatin：20 mg (every evening orally) for 8 weeks |
| placebo | Placebo comparator | Drug: placeboplacebo:20 mg (every evening orally) for 8 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin20 mg (every evening orally) for 8 weeks | Drug | Atorvastatin |
| placebo20 mg (every evening orally) for 8 weeks | Drug | placebo |
Primary outcome
Hematoma Reduced Amount.
Time frame: Check on 8 weeks during treatment (at the end)
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)
4 secondary outcomes
The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects
Time frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Changes of neurological symptoms and signs
Time frame: 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
Time frame: 0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.
Hematoma Reduced Amount
Time frame: 4 weeks during treatment, in the follow-up in 12 and 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 35133631Wang 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.
- Derived from this study: PubMed 30073290Jiang 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.
- Derived from this study: PubMed 26581842Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning jian zhang, MD, PhD principal investigator
Tianjin Medical University General Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Chronic Subdural Hematoma, run by Oriental Neurosurgery Evidence-Based-Study Team at 31 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma Reduced Amount. (time frame: Check on 8 weeks during treatment (at the end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02024373, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.