Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury

This study has been completed.
Sponsor:
Collaborators:
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca
Information provided by:
Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT00329758
First received: May 23, 2006
Last updated: June 23, 2010
Last verified: March 2009
  Purpose

The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.


Condition Intervention Phase
Head Injury
Drug: rosuvastatin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Galveston Orientation and Amnesia Test [ Time Frame: Days in be positive ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcome by Disability Rating Scale [ Time Frame: at 0 (release) and 3 months ] [ Designated as safety issue: No ]
  • Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ] [ Designated as safety issue: No ]
  • acute renal Insuficience [ Time Frame: Periode of medication (10 days) ] [ Designated as safety issue: Yes ]
  • Lesion on CT scan [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: rosuvastatin
20 mg oral, during 10 days
Other Name: Crestor
Placebo Comparator: 2 Drug: Placebo

Detailed Description:

The head injury is a frequent problem of health, which produces high morbid-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expenses in health care systems.

Head injury produces damage by primary mechanisms related to impact, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism. The management today is trying to avoid progression in secondary damage without good outcome. Many drugs and measures has been ineffective.

In the last years has been demonstrated in head injury microvascular damage like stroke. Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins.

We have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore outcome.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or woman >16 and <50 years with HI less 24 hours in progression and Glasgow between 9 y 12.
  • Man or woman >16 and <50 years with HI and Glasgow l3, with lesions in TC scan.
  • Acceptance of family to participate (first grade).

Exclusion Criteria:

  • History of HI with disability
  • History of neurological or psychiatric disease with disability.
  • Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.
  • Existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock).
  • Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters
  • Existence of intracranial lesion which needs surgery.
  • Lesions not classifiable or in brainstem.
  • Allergy to the drug.
  • Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease.
  • Management previous in other Hospital.
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329758

Locations
Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78240
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca
Investigators
Study Director: Jaime Torres-Corzo, Neurosurgeon Hospital Central "Dr. Ignacio Morones Prieto"
Principal Investigator: Humberto Tapia-Perez, MD Facultad de Medicina UASLP
  More Information

Publications:
Responsible Party: Humberto Tapia
ClinicalTrials.gov Identifier: NCT00329758     History of Changes
Other Study ID Numbers: 26-06ROHI
Study First Received: May 23, 2006
Last Updated: June 23, 2010
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Universidad Autonoma de San Luis Potosí:
moderate head injury
rosuvastatin
statin
amnesia
orientation

Additional relevant MeSH terms:
Amnesia
Craniocerebral Trauma
Delirium, Dementia, Amnestic, Cognitive Disorders
Memory Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014