Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094244
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-07-19
Brief Title:
Statins in Patients With Spontaneous Intracerebral Hemorrhage
Sponsor:
Pomeranian Medical University Szczecin
Organization:
Pomeranian Medical University Szczecin
Study Overview
Official Title:
Statins and 90-day Functional Efficiency and Survival in Patients With Spontaneous Intracerebral Hemorrhage
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgd and rosuvastatin of up to 10 mgd Persons who had never taken that medicine before subgroup Ib were administered atorvastatin of 20 mgday 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
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 mgd and rosuvastatin of up to 10 mgd Persons who had never taken that medicine before subgroup Ib were administered atorvastatin of 20 mgday 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 mgd and rosuvastatin of up to 10 mgd Persons who had never taken that medicine before subgroup Ib were administered atorvastatin of 20 mgday 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
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 mgd and rosuvastatin of up to 10 mgd Persons who had never taken that medicine before subgroup Ib were administered atorvastatin of 20 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None