NCT04718155

Brief Summary

3-Hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, known as statins, are widely used to reduce levels of low-density lipoprotein-cholesterol. As lipid-lowering drugs, statins exert neuroprotective effects on ischemic stroke. this study will investigate whether the protective effect of statins is mediated by their ability to impact inflammation and oxygen free radical levels in cerebral ischemia/reperfusion injury. Could Statins affect the neuroinflamation which occurs after traumatic brain injury?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

January 16, 2021

Last Update Submit

June 30, 2022

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injuryN-acetyl-aspartate

Outcome Measures

Primary Outcomes (1)

  • brain magnetic resonance spectroscopy

    presence or absence of abnormal metabolites seen by magnetic resonance spectroscopy

    first 48 hours

Secondary Outcomes (1)

  • ICU stay

    first 30 days

Study Arms (2)

statin group

ACTIVE COMPARATOR

will receive atorvastatin for 48 hours

Drug: Atorvastatin

control

PLACEBO COMPARATOR

will receive placebo tablets for 48 hours

Other: placebo

Interventions

AtorvastatinDRUG

will receive 40 mg atrorvastatin 2 days

statin group
placeboOTHER

will receive 40 mg placebo 2 days

control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- adult
  • traumatic brain injury mild to moderate

You may not qualify if:

  • immunotherapey
  • diabetic
  • previous CNs dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 22, 2021

Study Start

March 1, 2021

Primary Completion

April 30, 2022

Study Completion

June 1, 2022

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

EG(1)