Statins in Patients With Spontaneous Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The relation between improvement in results of treating spontaneous intracerebral hemorrhage
      (SICH) and the application of statins has been subject to numerous analyses, and yet still
      remains debatable. The options of treating SICH are limited, therefore neuroprotective
      effects of statins have become the subject of interest.

      The purpose of this work is to determine whether:

        1. the use of statins in the period prior to the spontaneous intracerebral hemorrhage has
           any impact on the initial neurological condition and the initial radiology

        2. continuing the statin treatment commenced before the spontaneous intracerebral
           hemorrhage or including statins into treatment at the acute stage of the disease
           deteriorates the course of the disease and prognosis during the in-hospital period

        3. continuing treatment with statins after the in-hospital treatment impacts functional
           efficiency and survival rate within the period of up to 90 days from the symptoms of
           spontaneous intracerebral hemorrhage occurring.

      The prospective study included 153 patients with diagnosed SICH who met the criteria for
      inclusion based on data collected in the course of interviews, neurological examinations,
      neuroimaging (head scans or magnetic resonance of the head) and laboratory test results,
      which additionally made it possible to exclude secondary hemorrhage causes.

      During the first stage of the study, patients were assigned to group I (without statins) and
      group II (taking statins).

      During the second stage of the study, having marked the lipid profile within the first three
      days of stay in hospital and excluded or confirmed dyslipidemia, group I was further divided
      into subgroups Ia and Ib. Subgroup Ia comprised those who were not diagnosed to have
      dyslipidemia - they did not receive statins; subgroup Ib comprised those with dyslipidemia
      who received statins and were recommended to take this medicine for 90 days since they
      occurrence of SICH. Group II patients continued to take the same dose of statins they had
      been taking before (atorvastatin or rosuvastatin) or if it had initially been low - increased
      doses of atorvastatin of up to 20 mg/d and rosuvastatin of up to 10 mg/d. Persons who had
      never taken that medicine before (subgroup Ib) were administered atorvastatin of 20 mg/day
      with the recommendation to take it for at least 90 days since the occurrence of SICH
      symptoms. The analysis pertained to the impact of statins during the acute period of SICH on
      its in-hospital course.

      The third stage consisted in analyzing the condition of the patients post hospitalization
      with the NIHSS Scale, Barthel Scale and modified Rankin Scale, with an examination carried
      out on the day they were released from hospital and 90 days from the occurrence of the
      symptoms of the disease.

      The fourth stage consisted in analyzing the survival rate of the patients.
    

Detailed description: 
      The relation between improvement in results of treating spontaneous intracerebral hemorrhage
      (SICH) and the application of statins has been subject to numerous analyses, and yet still
      remains debatable. The options of treating SICH are limited and focus on containing arterial
      hypertension, treating cerebral edema and providing supportive care, primarily physical and
      speech therapy, as well as preventing complications in bed-ridden patients in grave medical
      condition. Therefore, neuroprotective effects of statins have become the subject of interest,
      especially in the case of diseases with low possibilities of treatment but catastrophic
      health and social consequences, caused by SICH.

      The intended purpose of this work is to determine whether:

        1. the use of statins in the period prior to the spontaneous intracerebral hemorrhage has
           any impact on the initial neurological condition and the initial radiology

        2. continuing the statin treatment commenced before the spontaneous intracerebral
           hemorrhage or including statins into treatment at the acute stage of the disease
           deteriorates the course of the disease and prognosis during the in-hospital period

        3. continuing treatment with statins after the in-hospital treatment impacts functional
           efficiency and survival rate within the period of up to 90 days from the symptoms of
           spontaneous intracerebral hemorrhage occurring.

      The prospective study included 153 patients with diagnosed SICH who met the criteria for
      inclusion based on data collected in the course of interviews, neurological examinations,
      neuroimaging (head scans or magnetic resonance of the head) and laboratory test results,
      which additionally made it possible to exclude secondary hemorrhage causes.

      During the first stage of the study, patients were assigned to group I (without statins) and
      group II (taking statins).

      During the second stage of the study, having marked the lipid profile within the first three
      days of stay in hospital and excluded or confirmed dyslipidemia, group I was further divided
      into subgroups Ia and Ib. Subgroup Ia comprised those who were not diagnosed to have
      dyslipidemia - they did not receive statins; subgroup Ib comprised those with dyslipidemia
      who received statins and were recommended to take this medicine for 90 days since they
      occurrence of SICH. Group II patients continued to take the same dose of statins they had
      been taking before (atorvastatin or rosuvastatin) or if it had initially been low - increased
      doses of atorvastatin of up to 20 mg/d and rosuvastatin of up to 10 mg/d. Persons who had
      never taken that medicine before (subgroup Ib) were administered atorvastatin of 20 mg/day
      with the recommendation to take it for at least 90 days since the occurrence of SICH
      symptoms. The analysis pertained to the impact of statins during the acute period of SICH on
      its in-hospital course.

      The third stage consisted in analyzing the condition of the patients post hospitalization
      with the NIHSS Scale, Barthel Scale and modified Rankin Scale, with an examination carried
      out on the day they were released from hospital and 90 days from the occurrence of the
      symptoms of the disease. The examination was conducted directly or through a phone
      conversation with the patient or their caretaker with a uniform set of questions based on a
      scale.

      The fourth stage consisted in analyzing the survival rate of the patients.
    

Intervention name(s): Atorvastatin; Rosuvastatin; No drugs
Intervention type(s): Drug; Drug; Other
Intervention description(s): Doses of atorvastatin of up to 20 mg/d.; Doses of rosuvastatin of up to 10 mg/d.; No drugs
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SICH; Spontaneous intracerebral hemorrhage; Statins; Functional efficiency; NIHSS Scale; Rankin Scale; Barthel Scale; Intracerebral Hemorrhage; Stroke