Chronic Subdural HematomaPhase 3REACHNCT03956368
Efficacy of Atorvastatin in Chronic Subdural Haematoma
A Phase 3 study testing Atorvastatin 20mg in people with Chronic Subdural Hematoma, run by Chinese University of Hong Kong at 7 sites in Hong Kong.
Trial summary
This prospective, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of atorvastatin in patients with chronic subdural haematoma. The degree of disability or dependence in daily activities, as well as surgical intervention or recurrence, of the treatment and control groups will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Atorvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 690 participants
- Where
- 7 sitesHong Kong
- Study dates
- 9 Jan 2020to 16 Mar 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years old;
- Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT);
- Patients are joining the trial voluntarily with consent form signed.
Who cannot join
- Allergy to atorvastatin or other statins;
- Deranged liver function;
- Patients who are already on long term steroid for other condition(s);
- Patients who are already on statin for other condition(s);
- Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt);
- Pregnant or on breast feeding;
- Hematoma is secondary to tumour or haematological disorders;
- Patients taking angiotensin converting enzyme (ACE) inhibitor.
Trial locations and contacts
7 sites in 1 country.
Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg contact
7 sites in 1 country
Hong Kong7 sites, 7 recruiting
- Recruiting
Pamela Youde Nethersole Eastern Hospital
Chai Wan
Shing Kit Chan, MBBS, MRCS(Ed), MHKICBSC
- Recruiting
Queen Mary Hospital
Hong Kong
(Site PI) Anderson Chun On Tsang, MBBS(Hons),MHKICBSC,MRCS(Ed)
- Recruiting
Kwong Wah Hospital
Kowloon
(Site PI) Peter Yat Ming Woo, MBBS,MMedSc,FRCS,FCSHK,FHKAM
- Recruiting
Princess Margaret Hospital
Kowloon
(Site PI) Kwan Ho Chow, MBChB,HKICBS,FCSHK
- Recruiting
Queen Elizabeth Hospital
Kowloon
(Site PI) Calvin Hoi Kwan Mak, MBBS,MRCS,FRCSEd(SN),FHKAM
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg, +852 3505 2624 / 3505 1522, poonws@surgery.cuhk.edu.hk
Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg
- Recruiting
Tuen Mun Hospital
Tuenmen
(Site PI) Jason Man Kit Ho, MBChB (CUHK)
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)
This prospective, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of atorvastatin in patients with chronic subdural haematoma. The degree of disability or dependence in daily activities, as well as surgical intervention or recurrence, of the treatment and control groups will be compared.
Read the detailed description
Objectives: Chronic subdural haematoma (CSDH) is a common neurosurgical condition in the elderly population associated with mild head injury. Surgical drainage has been regarded as safe and effective. However, surgical complications including recurrences can result in poor functional outcome and fatality, particularly in the elderly patients. Atorvastatin, an HMGCoA reductase inhibitor and a widely prescribed lipid lowering medication has properties of inflammation modulation and neovasculature promotion.
Hypothesis: Atorvastatin can improve functional outcome in patients with CSDH for both initially non-operatively treated group (estimated to be 10%) and the operative group (90%) by reducing the rate of surgical intervention and recurrence rate.
Design: A prospective multicentre study of 690 consented patients with symptomatic CSDH will be randomised on the day of admission to receive atorvastatin 20 mg or a placebo daily for 8 weeks. All seven regional neurosurgical units in Hong Kong and two units outside Hong Kong, each treating 80-200 patients per annum, have been invited to participate.
Main Outcome Measures: Primary outcome: Modified Rankin Scale (mRS). Secondary outcome: surgical recurrence.
Sample Size: Assuming an absolute 10% improvement in favourable outcome in the Modified Rankin Scale score (mRS 0-3) at 6 months from the control group of 70% to the treatment group 80%, allowing a 10% loss to follow up, a sample size of 690 is required.
Expected Results: A successful study for improving clinical outcome of CSDH, an important illness of the elderly with an annual incidence of 58/100,000 will change clinical practice.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Atorvastatin 20mg, Placebos
- Keywords
- Chronic subdural haematoma, Medical treatment, Atorvastatin, Clinical outcome, Surgical recurrence
- 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.
Atorvastatin 20mgDrug
20mg (every evening orally) for 8 weeks.
PlacebosDrug
20mg (every evening orally) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks. Receives: Drug: Atorvastatin 20mg |
| Control Group | Placebo comparator | Randomised on the day of admission to receive placebo 20mg daily for 8 weeks. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favourable Modified Rankin Scale (mRS) score
Modified Rankin Scale score of 0-3
Measured: 6 months
Secondary outcomes (1)
Chronic subdural haematoma (CSDH) related surgical intervention
Recurrence rate in both initially non-operatively treated patients and operative cases
Measured: Throughout the study period, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start9 Jan 2020
- Primary completion16 Sep 2022 (estimated)
- Study completion16 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Wai Sang Poon, Chinese University of Hong Kong
- Investigators
- Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956368
- Sponsor's protocol ID
- REACH-v1
- Acronym
- REACH
- Status last verified
- Nov 2021
- First submitted
- 10 May 2019
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)
- ClinicalTrials.gov ID
- NCT03956368
- Acronym / sponsor ID
- REACH / REACH-v1
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural haematoma, Medical treatment, Atorvastatin, Clinical outcome, Surgical recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 16 Sep 2022 (estimated)
- Study completion
- 16 Mar 2023 (estimated)
- First posted
- 20 May 2019 (actual)
- 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.
This prospective, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of atorvastatin in patients with chronic subdural haematoma. The degree of disability or dependence in daily activities, as well as surgical intervention or recurrence, of the treatment and control groups will be compared.
Detailed description
Objectives: Chronic subdural haematoma (CSDH) is a common neurosurgical condition in the elderly population associated with mild head injury. Surgical drainage has been regarded as safe and effective. However, surgical complications including recurrences can result in poor functional outcome and fatality, particularly in the elderly patients. Atorvastatin, an HMGCoA reductase inhibitor and a widely prescribed lipid lowering medication has properties of inflammation modulation and neovasculature promotion.
Hypothesis: Atorvastatin can improve functional outcome in patients with CSDH for both initially non-operatively treated group (estimated to be 10%) and the operative group (90%) by reducing the rate of surgical intervention and recurrence rate.
Design: A prospective multicentre study of 690 consented patients with symptomatic CSDH will be randomised on the day of admission to receive atorvastatin 20 mg or a placebo daily for 8 weeks. All seven regional neurosurgical units in Hong Kong and two units outside Hong Kong, each treating 80-200 patients per annum, have been invited to participate.
Main Outcome Measures: Primary outcome: Modified Rankin Scale (mRS). Secondary outcome: surgical recurrence.
Sample Size: Assuming an absolute 10% improvement in favourable outcome in the Modified Rankin Scale score (mRS 0-3) at 6 months from the control group of 70% to the treatment group 80%, allowing a 10% loss to follow up, a sample size of 690 is required.
Expected Results: A successful study for improving clinical outcome of CSDH, an important illness of the elderly with an annual incidence of 58/100,000 will change clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Atorvastatin 20mgRandomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks. |
| Control Group | Placebo comparator | Drug: PlacebosRandomised on the day of admission to receive placebo 20mg daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years old;
- Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT);
- Patients are joining the trial voluntarily with consent form signed.
Key exclusion criteria (8 listed)
- Allergy to atorvastatin or other statins;
- Deranged liver function;
- Patients who are already on long term steroid for other condition(s);
- Patients who are already on statin for other condition(s);
- Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt);
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 |
|---|---|---|
| Atorvastatin 20mg20mg (every evening orally) for 8 weeks. | Drug | Treatment Group |
| Placebos20mg (every evening orally) for 8 weeks. | Drug | Control Group |
Primary outcome
Favourable Modified Rankin Scale (mRS) score
Time frame: 6 months
Modified Rankin Scale score of 0-3
1 secondary outcome
Chronic subdural haematoma (CSDH) related surgical intervention
Time frame: Throughout the study period, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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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.
Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg contact
Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg principal investigator
Chinese University of Hong Kong
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin 20mg in people with Chronic Subdural Hematoma, run by Chinese University of Hong Kong at 7 sites in Hong Kong.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Hong Kong. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg (+852 3505 2624 / 3505 1522, poonws@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favourable Modified Rankin Scale (mRS) score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2021.