Statins in Patients With Spontaneous Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

Statins and 90-day Functional Efficiency and Survival in Patients With Spontaneous Intracerebral Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094244
• Other study ID #: Pomeranian MU Szczecin
• Status: Completed
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: March 17, 2021

Study information

• Verified date: October 2023
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: March 17, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Years to 95 Years

Eligibility

Inclusion Criteria:

1. Age over 18 years old

2. Spontaneous intracerebral hemorrhage confirmed by computed tomography/MRI of the head

3. Taking statins: rosuvastatin or atorvastatin for at least 6 months - applies only to group II

Exclusion Criteria:

1. Secondary central nervous system bleeding (e.g. tumor, vascular malformation, haemorrhaged ischemic stroke, coagulopathy, anticoagulant therapy)

2. SAH/traumatic bleeding

3. Accompanying ischemic focus in the brain

4. Infection with fever and/or high inflammatory parameters on the day of admission to the hospital

5. Age under 18 years old

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• Atorvastatin
Doses of atorvastatin of up to 20 mg/d.
• Rosuvastatin
Doses of rosuvastatin of up to 10 mg/d.

Other:
• No drugs
No drugs

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin	West Pomeranian

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIHSS	NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.	24 hours
Primary	NIHSS	NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.	During hospital stay (up to 14 days)
Primary	Modified Rankin Scale	Modified Rankin Scale - Assessment of global disability, score range from 0 to 6, where 0 means full disability, 5 means full disability, and 6 means death.	During hospital stay (up to 14 days)
Primary	Barthel Scale	Barthel Scale - Assessment of the deficit in self-care, score from 0 to 100. From 0-20 are patients requiring complete care. 100 points means a person functioning independently.	During hospital stay (up to 14 days)
Primary	Mortality	Mortality Assessment - The number of deaths in a population during a given time or place.	During hospital stay (up to 14 days)
Primary	NIHSS	NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.	Up to 90 days
Primary	Modified Rankin Scale	Modified Rankin Scale - Assessment of global disability, score range from 0 to 6, where 0 means full disability, 5 means full disability, and 6 means death.	Up to 90 days
Primary	Barthel Scale	Barthel Scale - Assessment of the deficit in self-care, score from 0 to 100. From 0-20 are patients requiring complete care. 100 points means a person functioning independently.	Up to 90 days
Primary	Mortality	Mortality Assessment - The number of deaths in a population during a given time or place.	Up to 90 days