Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-03-09 @ 4:21 AM
Study NCT ID:
NCT03956368
Status:
UNKNOWN
Last Update Posted:
2021-11-22
First Post:
2019-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Atorvastatin in Chronic Subdural Haematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 690}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-03-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Glasgow Outcome Scale (GOS)', 'timeFrame': '2 weeks, 8 weeks, 3 months, and 6 months', 'description': '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.'}, {'measure': 'Imaging diagnosis', 'timeFrame': 'Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months', 'description': '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.'}, {'measure': 'Barthel Index (BI)', 'timeFrame': '2 weeks, 8 weeks, 3 months, and 6 months', 'description': '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.'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': '2 weeks, 8 weeks, 3 months, and 6 months', 'description': 'One-page test for detecting cognitive impairment. The score ranges from 0-30 with a higher score indicating better outcome.'}, {'measure': 'Modified Rankin Scale', 'timeFrame': '2 weeks, 8 weeks, 3 months, and 6 months', 'description': 'Scale for measuring the degree of disability or dependence in the daily activities of patients with brain injury.'}], 'primaryOutcomes': [{'measure': 'Favourable Modified Rankin Scale (mRS) score', 'timeFrame': '6 months', 'description': 'Modified Rankin Scale score of 0-3'}], 'secondaryOutcomes': [{'measure': 'Chronic subdural haematoma (CSDH) related surgical intervention', 'timeFrame': 'Throughout the study period, an average of 6 months', 'description': 'Recurrence rate in both initially non-operatively treated patients and operative cases'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic subdural haematoma', 'Medical treatment', 'Atorvastatin', 'Clinical outcome', 'Surgical recurrence'], 'conditions': ['Chronic Subdural Hematoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHypothesis: 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.\n\nDesign: 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.\n\nMain Outcome Measures: Primary outcome: Modified Rankin Scale (mRS). Secondary outcome: surgical recurrence.\n\nSample 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.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than or equal to 18 years old;\n2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT);\n3. Patients are joining the trial voluntarily with consent form signed.\n\nExclusion Criteria:\n\n1. Allergy to atorvastatin or other statins;\n2. Deranged liver function;\n3. Patients who are already on long term steroid for other condition(s);\n4. Patients who are already on statin for other condition(s);\n5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt);\n6. Pregnant or on breast feeding;\n7. Hematoma is secondary to tumour or haematological disorders;\n8. Patients taking angiotensin converting enzyme (ACE) inhibitor.'}, 'identificationModule': {'nctId': 'NCT03956368', 'acronym': 'REACH', 'briefTitle': 'Efficacy of Atorvastatin in Chronic Subdural Haematoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Trial on the Efficacy of Atorvastatin in Chronic Subdural Haematoma (The REACH Study)', 'orgStudyIdInfo': {'id': 'REACH-v1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.', 'interventionNames': ['Drug: Atorvastatin 20mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Atorvastatin 20mg', 'type': 'DRUG', 'description': '20mg (every evening orally) for 8 weeks.', 'armGroupLabels': ['Treatment Group']}, {'name': 'Placebos', 'type': 'DRUG', 'description': '20mg (every evening orally) for 8 weeks.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'New Territories', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg', 'role': 'CONTACT', 'email': 'poonws@surgery.cuhk.edu.hk', 'phone': '+852 3505 2624 / 3505 1522'}, {'name': 'Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Yuen Chung Chan, MRCSEd', 'role': 'SUB_INVESTIGATOR'}, {'name': 'George Kwok Chu Wong, MBChB,MD,FRCSEd,FCSHK-Surg', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephanie Chi Ping Ng, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'William B Goggins, ScD, SM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Chai Wan', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shing Kit Chan, MBBS, MRCS(Ed), MHKICBSC', 'role': 'CONTACT'}], 'facility': 'Pamela Youde Nethersole Eastern Hospital', 'geoPoint': {'lat': 22.26718, 'lon': 114.24051}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': '(Site PI) Anderson Chun On Tsang, MBBS(Hons),MHKICBSC,MRCS(Ed)', 'role': 'CONTACT'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': '(Site PI) Peter Yat Ming Woo, MBBS,MMedSc,FRCS,FCSHK,FHKAM', 'role': 'CONTACT'}], 'facility': 'Kwong Wah Hospital', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}, {'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': '(Site PI) Kwan Ho Chow, MBChB,HKICBS,FCSHK', 'role': 'CONTACT'}], 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}, {'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': '(Site PI) Calvin Hoi Kwan Mak, MBBS,MRCS,FRCSEd(SN),FHKAM', 'role': 'CONTACT'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}, {'city': 'Tuenmen', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': '(Site PI) Jason Man Kit Ho, MBChB (CUHK)', 'role': 'CONTACT'}], 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.39175, 'lon': 113.97157}}], 'centralContacts': [{'name': 'Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg', 'role': 'CONTACT', 'email': 'poonws@surgery.cuhk.edu.hk', 'phone': '+852 3505 2624 / 3505 1522'}], 'overallOfficials': [{'name': 'Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair Professor & Chief in Neurosurgery', 'investigatorFullName': 'Prof. Wai Sang Poon', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}