Efficacy of Atorvastatin in Chronic Subdural Haematoma

NCT03956368 | Unknown Phase 3

• 1 other identifier: REACH-v1
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic subdural haematoma; Medical treatment; Atorvastatin; Clinical outcome; Surgical recurrence

Outcome Measures

Primary Outcomes (1)

• Favourable Modified Rankin Scale (mRS) score

  Modified Rankin Scale score of 0-3

  6 months

Secondary Outcomes (1)

• Chronic subdural haematoma (CSDH) related surgical intervention

  Throughout the study period, an average of 6 months

Other Outcomes (5)

• Glasgow Outcome Scale (GOS)

  2 weeks, 8 weeks, 3 months, and 6 months

• Imaging diagnosis

  Index admission, 1-2 weeks early post-operation or before discharge, 3 months, 6 months

• Barthel Index (BI)

  2 weeks, 8 weeks, 3 months, and 6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Randomised on the day of admission to receive oral Atorvastatin 20mg daily for 8 weeks.

Drug: Atorvastatin 20mg

Control Group

PLACEBO COMPARATOR

Randomised on the day of admission to receive placebo 20mg daily for 8 weeks.

Drug: Placebos

Interventions

Atorvastatin 20mg DRUG

20mg (every evening orally) for 8 weeks.

Treatment Group

Placebos DRUG

20mg (every evening orally) for 8 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (7)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Kwong Wah Hospital

Kowloon, Hong Kong

RECRUITING

Princess Margaret Hospital

Kowloon, Hong Kong

RECRUITING

Queen Elizabeth Hospital

Kowloon, Hong Kong

RECRUITING

Tuen Mun Hospital

Tuenmen, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai Sang Poon, MBChB-Glasg FRCSEd FHKAM-Surg

CONTACT

+852 3505 2624 / 3505 1522; poonws@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor & Chief in Neurosurgery

Model Details: Eligible subjects will be randomised upon admission to receive atorvastin 20mg nocte or placebo for 8 weeks.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 20, 2019
• Study Start: January 9, 2020
• Primary Completion: September 16, 2022
• Study Completion: March 16, 2023
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

HK (7)