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Effect of Rosuvastatin in Intracerebral Hemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364559
First Posted: August 15, 2006
Last Update Posted: March 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidad Autonoma de San Luis Potosí
  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
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage

Resource links provided by NLM:


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

Primary Outcome Measures:
  • NIHSSº [ Time Frame: basal and discharge ]

Secondary Outcome Measures:
  • Survivor [ Time Frame: within 1 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Humberto Tapia
ClinicalTrials.gov Identifier: NCT00364559     History of Changes
Other Study ID Numbers: 29-09 ROICH
First Submitted: August 14, 2006
First Posted: August 15, 2006
Last Update Posted: March 26, 2009
Last Verified: March 2009

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

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