Intracerebral HemorrhageNCT06094244
Statins in Patients With Spontaneous Intracerebral Hemorrhage
A study testing Atorvastatin, Rosuvastatin and No drugs in people with Intracerebral Hemorrhage, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 36 to 95 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Atorvastatin, Rosuvastatin and No drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 sitePoland
- Study dates
- 17 Mar 2017to 17 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, 58-400
About this study
Official title: Statins and 90-day Functional Efficiency and Survival in Patients With Spontaneous Intracerebral Hemorrhage
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:
Read more
- 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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Atorvastatin, Rosuvastatin, No drugs
- Keywords
- SICH, Spontaneous intracerebral hemorrhage, Statins, Functional efficiency, NIHSS Scale, Rankin Scale, Barthel Scale, Intracerebral Hemorrhage, Stroke
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Doses of atorvastatin of up to 20 mg/d.
RosuvastatinDrug
Doses of rosuvastatin of up to 10 mg/d.
No drugsOther
No drugs
| Study group | Role | What they receive |
|---|---|---|
| Group I Patients who were not taking statins prior to the occurrence of SICH | Experimental | Patients who were not taking statins prior to the occurrence of SICH. Receives: Other: No drugs |
| Group II Patients who were taking statins prior to the occurrence of SICH | Experimental | Patients who were taking statins prior to the occurrence of SICH. Receives: Drug: Atorvastatin; Drug: Rosuvastatin |
| Subgroup Ia Patients were not diagnosed to dyslipidemia. They did not receive statins. | Experimental | Patients who were not diagnosed to have dyslipidemia during hospitalization. They did not receive statins. Receives: Other: No drugs |
| Subgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days. | Experimental | Patients with dyslipidemia diagnosed during hospitalization who received statins and were recommended to take this medicine for 90 days since they occurrence of SICH. Receives: Drug: Atorvastatin; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Measured: 24 hours
NIHSS
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Measured: During hospital stay (up to 14 days)
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.
Measured: During hospital stay (up to 14 days)
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.
Measured: During hospital stay (up to 14 days)
Mortality
Mortality Assessment - The number of deaths in a population during a given time or place.
Measured: During hospital stay (up to 14 days)
NIHSS
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Measured: Up to 90 days
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.
Measured: Up to 90 days
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.
Measured: Up to 90 days
Mortality
Mortality Assessment - The number of deaths in a population during a given time or place.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start17 Mar 2017
- Primary completion31 Dec 2020
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Zaryczańska, Pomeranian Medical University Szczecin
- Investigators
- Karolina Zaryczańska, PhD, MD, Principal investigator, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094244
- Sponsor's protocol ID
- Pomeranian MU Szczecin
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins and 90-day Functional Efficiency and Survival in Patients With Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06094244
- Acronym / sponsor ID
- Pomeranian MU Szczecin
- Conditions
- Intracerebral Hemorrhage
- Keywords
- SICH, Spontaneous intracerebral hemorrhage, Statins, Functional efficiency, NIHSS Scale, Rankin Scale, Barthel Scale, Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I Patients who were not taking statins prior to the occurrence of SICH | Experimental | Other: No drugsPatients who were not taking statins prior to the occurrence of SICH. |
| Group II Patients who were taking statins prior to the occurrence of SICH | Experimental | Drug: Atorvastatin, Drug: RosuvastatinPatients who were taking statins prior to the occurrence of SICH. |
| Subgroup Ia Patients were not diagnosed to dyslipidemia. They did not receive statins. | Experimental | Other: No drugsPatients who were not diagnosed to have dyslipidemia during hospitalization. They did not receive statins. |
| Subgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days. | Experimental | Drug: Atorvastatin, Drug: RosuvastatinPatients with dyslipidemia diagnosed during hospitalization who received statins and were recommended to take this medicine for 90 days since they occurrence of SICH. |
Who may qualify
- Ages
- 36 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinDoses of atorvastatin of up to 20 mg/d. | Drug | Group II Patients who were taking statins prior to the occurrence of SICH, Subgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days. |
| RosuvastatinDoses of rosuvastatin of up to 10 mg/d. | Drug | Group II Patients who were taking statins prior to the occurrence of SICH, Subgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days. |
| No drugsNo drugs | Other | Group I Patients who were not taking statins prior to the occurrence of SICH, Subgroup Ia Patients were not diagnosed to dyslipidemia. They did not receive statins. |
Primary outcome
NIHSS
Time frame: 24 hours
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
NIHSS
Time frame: During hospital stay (up to 14 days)
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Modified Rankin Scale
Time frame: During hospital stay (up to 14 days)
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
Time frame: During hospital stay (up to 14 days)
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
Time frame: During hospital stay (up to 14 days)
Mortality Assessment - The number of deaths in a population during a given time or place.
NIHSS
Time frame: Up to 90 days
NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.
Modified Rankin Scale
Time frame: Up to 90 days
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
Time frame: Up to 90 days
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
Time frame: Up to 90 days
Mortality Assessment - The number of deaths in a population during a given time or place.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karolina Zaryczańska, PhD, MD principal investigator
Pomeranian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin, Rosuvastatin and No drugs in people with Intracerebral Hemorrhage, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS (time frame: 24 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.