Statins in Patients With Spontaneous Intracerebral Hemorrhage

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:

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.

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Other: No drugs; Drug: Atorvastatin; Drug: Rosuvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • West Pomeranian
    • Szczecin, West Pomeranian, Poland, 58-400
      • Pomeranian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I Patients who were not taking statins prior to the occurrence of SICH; Patients who were not taking statins prior to the occurrence of SICH.	Other: No drugs; No drugs
Experimental: Group II Patients who were taking statins prior to the occurrence of SICH; Patients who were taking statins prior to the occurrence of SICH.	Drug: Atorvastatin; Doses of atorvastatin of up to 20 mg/d.; Drug: Rosuvastatin; Doses of rosuvastatin of up to 10 mg/d.
Experimental: Subgroup Ia Patients were not diagnosed to dyslipidemia. They did not receive statins.; Patients who were not diagnosed to have dyslipidemia during hospitalization. They did not receive statins.	Other: No drugs; No drugs
Experimental: Subgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days.; Patients with dyslipidemia diagnosed during hospitalization who received statins and were recommended to take this medicine for 90 days since they occurrence of SICH.	Drug: Atorvastatin; Doses of atorvastatin of up to 20 mg/d.; Drug: Rosuvastatin; Doses of rosuvastatin of up to 10 mg/d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS	NIHSS - Assessment of neurological deficit on a scale from 0 to 42. The higher the number, the deeper the neurological deficit.	24 hours
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)
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)
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)
Mortality	Mortality Assessment - The number of deaths in a population during a given time or place.	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.	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.	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.	Up to 90 days
Mortality	Mortality Assessment - The number of deaths in a population during a given time or place.	Up to 90 days

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Investigators: Principal Investigator: Karolina Zaryczańska, PhD, MD, Pomeranian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 17, 2021

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Statins; Intracerebral Hemorrhage; Spontaneous intracerebral hemorrhage; Barthel Scale; SICH; Functional efficiency; NIHSS Scale; Rankin Scale
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: Pomeranian MU Szczecin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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