NCT06094244

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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

July 19, 2023

Last Update Submit

October 16, 2023

Conditions

Intracerebral Hemorrhage

Keywords

SICHSpontaneous intracerebral hemorrhageStatinsFunctional efficiencyNIHSS ScaleRankin ScaleBarthel ScaleIntracerebral HemorrhageStroke

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (4)

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.

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.

Drug: AtorvastatinDrug: 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.

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.

Drug: AtorvastatinDrug: Rosuvastatin

Interventions

AtorvastatinDRUG

Doses of atorvastatin of up to 20 mg/d.

Group II Patients who were taking statins prior to the occurrence of SICHSubgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days.
RosuvastatinDRUG

Doses of rosuvastatin of up to 10 mg/d.

Group II Patients who were taking statins prior to the occurrence of SICHSubgroup Ib Patients with dyslipidemia Received statins, recommended to take medicine for 90 days.
No drugsOTHER

No drugs

Group I Patients who were not taking statins prior to the occurrence of SICHSubgroup Ia Patients were not diagnosed to dyslipidemia. They did not receive statins.

Eligibility Criteria

Age36 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 58-400, Poland

Location

MeSH Terms

Conditions

Cerebral HemorrhageStroke

Interventions

AtorvastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Karolina Zaryczańska, PhD, MD

    Pomeranian Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Karolina Zaryczańska, MD, PhD

Study Record Dates

First Submitted

July 19, 2023

First Posted

October 23, 2023

Study Start

March 17, 2017

Primary Completion

December 31, 2020

Study Completion

March 17, 2021

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)