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Completed

NCT Number: NCT00364559

Effect of Rosuvastatin in Intracerebral Hemorrhage

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.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78240, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

20 mg 10 days daily

Other names: Crestor

Primary outcomes

  1. NIHSSº

    Time frame: basal and discharge

Secondary outcomes

  1. Survivor

    Time frame: within 1 month

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Aug 15, 2006
Registry last updated
Mar 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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