Statins in Patients With Spontaneous Intracerebral Hemorrhage

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.

Conditions

• Intracerebral Hemorrhage

Interventions

DRUG

Atorvastatin

Doses of atorvastatin of up to 20 mg/d.

DRUG

Rosuvastatin

Doses of rosuvastatin of up to 10 mg/d.

OTHER

No drugs

No drugs

Sponsors & Collaborators

• Pomeranian Medical University Szczecin

  lead OTHER

Principal Investigators

• Karolina Zaryczańska, PhD, MD · Pomeranian Medical University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

36 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-17

Primary Completion

2020-12-31

Completion

2021-03-17

Countries

• Poland

Study Locations