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Statins in Patients With Spontaneous Intracerebral Hemorrhage

Primary Purpose

Intracerebral Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Atorvastatin
Rosuvastatin
No drugs
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring SICH, Spontaneous intracerebral hemorrhage, Statins, Functional efficiency, NIHSS Scale, Rankin Scale, Barthel Scale, Intracerebral Hemorrhage, Stroke

Eligibility Criteria

36 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age over 18 years old Spontaneous intracerebral hemorrhage confirmed by computed tomography/MRI of the head Taking statins: rosuvastatin or atorvastatin for at least 6 months - applies only to group II Exclusion Criteria: Secondary central nervous system bleeding (e.g. tumor, vascular malformation, haemorrhaged ischemic stroke, coagulopathy, anticoagulant therapy) SAH/traumatic bleeding Accompanying ischemic focus in the brain Infection with fever and/or high inflammatory parameters on the day of admission to the hospital Age under 18 years old

Sites / Locations

  • Pomeranian Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group I Patients who were not taking statins prior to the occurrence of SICH

Group II Patients who were taking statins prior to the occurrence of SICH

Subgroup Ia Patients were not diagnosed to dyslipidemia. They did not receive statins.

Subgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days.

Arm Description

Patients who were not taking statins prior to the occurrence of SICH.

Patients who were taking statins prior to the occurrence of SICH.

Patients who were not diagnosed to have dyslipidemia during hospitalization. They did not receive statins.

Patients with dyslipidemia diagnosed during hospitalization who received statins and were recommended to take this medicine for 90 days since they occurrence of SICH.

Outcomes

Primary Outcome Measures

NIHSS
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
NIHSS
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
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.
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.
Mortality
Mortality Assessment - The number of deaths in a population during a given time or place.
NIHSS
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
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.
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.
Mortality
Mortality Assessment - The number of deaths in a population during a given time or place.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2023
Last Updated
October 16, 2023
Sponsor
Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT06094244
Brief Title
Statins in Patients With Spontaneous Intracerebral Hemorrhage
Official Title
Statins and 90-day Functional Efficiency and Survival in Patients With Spontaneous Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: 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 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 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: 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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
SICH, Spontaneous intracerebral hemorrhage, Statins, Functional efficiency, NIHSS Scale, Rankin Scale, Barthel Scale, Intracerebral Hemorrhage, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I Patients who were not taking statins prior to the occurrence of SICH
Arm Type
Experimental
Arm Description
Patients who were not taking statins prior to the occurrence of SICH.
Arm Title
Group II Patients who were taking statins prior to the occurrence of SICH
Arm Type
Experimental
Arm Description
Patients who were taking statins prior to the occurrence of SICH.
Arm Title
Subgroup Ia Patients were not diagnosed to dyslipidemia. They did not receive statins.
Arm Type
Experimental
Arm Description
Patients who were not diagnosed to have dyslipidemia during hospitalization. They did not receive statins.
Arm Title
Subgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days.
Arm Type
Experimental
Arm Description
Patients with dyslipidemia diagnosed during hospitalization who received statins and were recommended to take this medicine for 90 days since they occurrence of SICH.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Doses of atorvastatin of up to 20 mg/d.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Doses of rosuvastatin of up to 10 mg/d.
Intervention Type
Other
Intervention Name(s)
No drugs
Intervention Description
No drugs
Primary Outcome Measure Information:
Title
NIHSS
Description
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Time Frame
24 hours
Title
NIHSS
Description
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Time Frame
During hospital stay (up to 14 days)
Title
Modified Rankin Scale
Description
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.
Time Frame
During hospital stay (up to 14 days)
Title
Barthel Scale
Description
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.
Time Frame
During hospital stay (up to 14 days)
Title
Mortality
Description
Mortality Assessment - The number of deaths in a population during a given time or place.
Time Frame
During hospital stay (up to 14 days)
Title
NIHSS
Description
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Time Frame
Up to 90 days
Title
Modified Rankin Scale
Description
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.
Time Frame
Up to 90 days
Title
Barthel Scale
Description
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.
Time Frame
Up to 90 days
Title
Mortality
Description
Mortality Assessment - The number of deaths in a population during a given time or place.
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years old Spontaneous intracerebral hemorrhage confirmed by computed tomography/MRI of the head Taking statins: rosuvastatin or atorvastatin for at least 6 months - applies only to group II Exclusion Criteria: Secondary central nervous system bleeding (e.g. tumor, vascular malformation, haemorrhaged ischemic stroke, coagulopathy, anticoagulant therapy) SAH/traumatic bleeding Accompanying ischemic focus in the brain Infection with fever and/or high inflammatory parameters on the day of admission to the hospital Age under 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karolina Zaryczańska, PhD, MD
Organizational Affiliation
Pomeranian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pomeranian Medical University
City
Szczecin
State/Province
West Pomeranian
ZIP/Postal Code
58-400
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Statins in Patients With Spontaneous Intracerebral Hemorrhage

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