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Effect of Rosuvastatin in Intracerebral Hemorrhage

This study has been completed.
Sponsor:
Information provided by:
Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT00364559
First received: August 14, 2006
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to determine whether rosuvastatin is effective in the management of acute phase of intracerebral hemorrhage and if it impact outcome by NIHSS.


Condition Intervention Phase
Intracerebral Hemorrhage
Stroke
 Drug: Rosuvastatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • NIHSSº [ Time Frame: basal and discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survivor [ Time Frame: within 1 month ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: August 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
A, Active B, Historical Register
 Drug: Rosuvastatin
20 mg 10 days daily
Other Name: Crestor

Detailed Description:

The intracerebral hemorrhage (ICH) is a frequent problem of health, with high morbid-mortality. In addition it originates expensive expenses in health care systems.

ICH produces damage by mass effect, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, now we know there are ischemic changes related maybe with changes in cerebral flow and metabolism, in addition to activate inflammatory ways. Many drugs and measures has been ineffective for getting best outcome, without success.

Statins or inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke and ICH 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 to demonstrate if the administration of rosuvastatin in the first 24 hours and by 14 days has improvement in outcome.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or Women >16 and < 80 years with ICH and hospital attention in less 24 hours
  • Confirmation by CT scan
  • Acceptance by family

Exclusion Criteria:

  • History of stroke
  • History of neurological disease, head injury o psychiatric disorder with disability
  • Glasgow less than 9
  • Administration 24 hours before: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone.
  • Use before hospital of: mannitol, barbiturates, corticosteroids, calcium antagonists
  • Any lesion which needs surgery
  • Allergy to drug used
  • cerebral death
  • Hepatic disease (Child B y C) or myopathy (or) history
  • Management in other Hospital
  • Pregnancy
  • ICH major than 60 ml.
  • hypothyroidism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364559

Locations
Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78240
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Investigators
Study Director: Ildefonso Rodríguez-Leyva, Neurology Neurología, Hospital Central "Dr. ignacio Morones Prieto"
Principal Investigator: Humberto Tapia-Perez, MD Facultad de Medicina UASLP
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Humberto Tapia
ClinicalTrials.gov Identifier: NCT00364559     History of Changes
Other Study ID Numbers: 29-09 ROICH
Study First Received: August 14, 2006
Last Updated: March 25, 2009
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Universidad Autonoma de San Luis Potosí:
intracerebral hemorrhage
statins
rosuvastatin
stroke

Additional relevant MeSH terms:
Hemorrhage
Stroke
Cerebral Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
 Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013