Effect of Rosuvastatin in Intracerebral Hemorrhage

Stroke Clinical Trial

Official title:

Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364559
• Other study ID #: 29-09 ROICH
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2006
• Last updated: March 25, 2009
• Start date: August 2006
• Est. completion date: December 2006

Study information

• Verified date: March 2009
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Stroke

Intervention

Drug:
• Rosuvastatin
20 mg 10 days daily

Locations

Country	Name	City	State
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J, Rodriguez-Leyva I, Herrera-Gonzalez LB. [Statins and brain protection mechanisms]. Rev Neurol. 2007 Sep 16-30;45(6):359-64. Review. Spanish. — View Citation

Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo JG, Rodriguez-Leyva I, Gonzalez-Aguirre D, Gordillo-Moscoso A, Chalita-Williams C. Use of statins for the treatment of spontaneous intracerebral hemorrhage: results of a pilot study. Cent Eur Neurosurg. 2009 — View Citation

Tapia-Pérez H, Torres-Corzo J, Sanchez-Aguilar M, González-Aguirre D, Rodríguez-Leyva I, Teniente-Sánchez AE, Gordillo-Moscoso A. [A clinical-epidemiological approximation to intracerebral hemorrhage in a Mexican hospital: analysis of factors associated to mortality]. Rev Neurol. 2008 Jan 16-31;46(2):67-72. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIHSSº		basal and discharge	No
Secondary	Survivor		within 1 month	No

External Links

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