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出境医 / 临床实验 / Efficacy of Atorvastatin in Chronic Subdural Haematoma (REACH)

Efficacy of Atorvastatin in Chronic Subdural Haematoma (REACH)

Study Description
Brief 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 be compared.

Condition or disease Intervention/treatment Phase
Chronic Subdural Hematoma Drug: Atorvastatin 20mg Drug: Placebos Phase 3

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment Group
Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.
 Drug: Atorvastatin 20mg
20mg (every evening orally) for 8 weeks.
Placebo Comparator: Control Group
Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.
 Drug: Placebos
20mg (every evening orally) for 8 weeks.
Outcome Measures
Primary Outcome Measures :
  1. Favourable Modified Rankin Scale (mRS) score [ Time Frame: 6 months ]
    Modified Rankin Scale score of 0-3


Secondary Outcome Measures :
  1. Chronic subdural haematoma (CSDH) related surgical intervention [ Time Frame: Throughout the study period, an average of 6 months ]
    Recurrence rate in both initially non-operatively treated patients and operative cases


Other Outcome Measures:
  1. Glasgow Outcome Scale (GOS) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Gross clinical outcome measure which allows standardised descriptions (good recovery, moderate disability, severe disability, persistent vegetative state, and death, with good recovery indicating the best outcome and death indicating the worst) for the degree of recovery in patients with brain damage.

  2. Imaging diagnosis [ Time Frame: Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months ]
    Computed Tomography (CT) brain scan to exclude the presence of air and new blood in subdural space at 1-2 weeks and to elevate the clarification of CSDH resolution at 3 months and 6 months.

  3. Barthel Index (BI) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Ordinal scale used to measure performance in activities of daily living (ADL) which uses 10 variables describing ADL and mobility. Scores range from 0-100 with 0 indicating the worst outcome and 100 indicating the best outcome.

  4. Montreal Cognitive Assessment (MoCA) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    One-page test for detecting cognitive impairment. The score ranges from 0-30 with a higher score indicating better outcome.

  5. Modified Rankin Scale [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 18 years old;
  2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT);
  3. Patients are joining the trial voluntarily with consent form signed.

Exclusion Criteria:

  1. Allergy to atorvastatin or other statins;
  2. Deranged liver function;
  3. Patients who are already on long term steroid for other condition(s);
  4. Patients who are already on statin for other condition(s);
  5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt);
  6. Pregnant or on breast feeding;
  7. Hematoma is secondary to tumour or haematological disorders;
  8. Patients taking angiotensin converting enzyme (ACE) inhibitor.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg +852 3505 2624 / 3505 1522 poonws@surgery.cuhk.edu.hk

Locations
Layout table for location information
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, New Territories, Hong Kong
Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg    +852 3505 2624 / 3505 1522    poonws@surgery.cuhk.edu.hk   
Principal Investigator: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg         
Sub-Investigator: David Yuen Chung Chan, MRCSEd         
Sub-Investigator: George Kwok Chu Wong, MBChB,MD,FRCSEd,FCSHK-Surg         
Sub-Investigator: Stephanie Chi Ping Ng, PhD         
Sub-Investigator: William B Goggins, ScD, SM         
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: (Site PI) Anderson Chun On Tsang, MBBS(Hons),MHKICBSC,MRCS(Ed)         
Kwong Wah Hospital Recruiting
Kowloon, Hong Kong
Contact: (Site PI) Peter Yat Ming Woo, MBBS,MMedSc,FRCS,FCSHK,FHKAM         
Princess Margaret Hospital Recruiting
Kowloon, Hong Kong
Contact: (Site PI) Kwan Ho Chow, MBChB,HKICBS,FCSHK         
Queen Elizabeth Hospital Recruiting
Kowloon, Hong Kong
Contact: (Site PI) Calvin Hoi Kwan Mak, MBBS,MRCS,FRCSEd(SN),FHKAM         
Tuen Mun Hospital Recruiting
Tuen Mun, Hong Kong
Contact: (Site PI) Jason Man Kit Ho, MBChB (CUHK)         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg Chinese University of Hong Kong
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE January 9, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019) 		Favourable Modified Rankin Scale (mRS) score [ Time Frame: 6 months ]
Modified Rankin Scale score of 0-3
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019) 		Chronic subdural haematoma (CSDH) related surgical intervention [ Time Frame: Throughout the study period, an average of 6 months ]
Recurrence rate in both initially non-operatively treated patients and operative cases
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2019)
  • Glasgow Outcome Scale (GOS) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Gross clinical outcome measure which allows standardised descriptions (good recovery, moderate disability, severe disability, persistent vegetative state, and death, with good recovery indicating the best outcome and death indicating the worst) for the degree of recovery in patients with brain damage.
  • Imaging diagnosis [ Time Frame: Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months ]
    Computed Tomography (CT) brain scan to exclude the presence of air and new blood in subdural space at 1-2 weeks and to elevate the clarification of CSDH resolution at 3 months and 6 months.
  • Barthel Index (BI) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Ordinal scale used to measure performance in activities of daily living (ADL) which uses 10 variables describing ADL and mobility. Scores range from 0-100 with 0 indicating the worst outcome and 100 indicating the best outcome.
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    One-page test for detecting cognitive impairment. The score ranges from 0-30 with a higher score indicating better outcome.
  • Modified Rankin Scale [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury.
Original Other Pre-specified Outcome Measures
 (submitted: May 17, 2019)
  • Glasgow Outcome Scale (GOS) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Gross clinical outcome measure which allows standardised descriptions for the degree of recovery in patients with brain damage.
  • Imaging diagnosis [ Time Frame: Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months ]
    Computed Tomography (CT) brain scan to exclude the presence of air and new blood in subdural space at 1-2 weeks and to elevate the clarification of CSDH resolution at 3 months and 6 months.
  • Barthel Index (BI) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Scale used to measure performance in activities of daily living.
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Test for detecting cognitive impairment.
  • Modified Rankin Scale [ Time Frame: 2 weeks, 8 weeks, 3 months, and 6 months ]
    Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury.
 
Descriptive Information
Brief Title  ICMJE Efficacy of Atorvastatin in Chronic Subdural Haematoma
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Subdural Hematoma
Intervention  ICMJE
  • Drug: Atorvastatin 20mg
    20mg (every evening orally) for 8 weeks.
  • Drug: Placebos
    20mg (every evening orally) for 8 weeks.
Study Arms  ICMJE
  • Experimental: Treatment Group
    Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.
    Intervention: Drug: Atorvastatin 20mg
  • Placebo Comparator: Control Group
    Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2019) 		690
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age greater than or equal to 18 years old;
  2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT);
  3. Patients are joining the trial voluntarily with consent form signed.

Exclusion Criteria:

  1. Allergy to atorvastatin or other statins;
  2. Deranged liver function;
  3. Patients who are already on long term steroid for other condition(s);
  4. Patients who are already on statin for other condition(s);
  5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt);
  6. Pregnant or on breast feeding;
  7. Hematoma is secondary to tumour or haematological disorders;
  8. Patients taking angiotensin converting enzyme (ACE) inhibitor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg +852 3505 2624 / 3505 1522 poonws@surgery.cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956368
Other Study ID Numbers  ICMJE REACH-v1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Wai Sang Poon, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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