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Study on Statins for Frail Older Patients with Recent Ischemic Stroke or TIA: Fluvastatin, Simvastatin, Pravastatin Sodium, Atorvastatin, and Rosuvastatin Combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of certain medications called statins in older adults who have experienced an ischemic stroke or a transient ischemic attack (TIA). These conditions occur when blood flow to the brain is temporarily blocked, leading to symptoms like weakness or difficulty speaking. The medications being studied include Fluvastatin, Simvastatin, Pravastatin Sodium, Atorvastatin, and Rosuvastatin. These are commonly used to lower cholesterol levels and reduce the risk of heart problems.

The purpose of the study is to evaluate how starting statin therapy affects the survival and quality of life of frail individuals aged 70 and above who have recently had a stroke or TIA. Participants will be randomly assigned to receive either a statin or a placebo. The study will follow participants for up to three years, with regular check-ins to monitor their health and any major cardiovascular events, such as heart attacks or strokes. The study will also assess participants' quality of life and cognitive function, which refers to their ability to think, learn, and remember.

Throughout the study, participants will be asked to attend regular follow-up visits to track their progress. These visits will occur at 3, 6, 12, 18, and 24 months, with additional follow-up for those who join the study early. The study aims to provide valuable insights into the benefits and risks of using statins in older adults who have experienced a stroke or TIA, helping to guide future treatment decisions for this population.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, which is to evaluate the effect of starting statin therapy on survival without major heart-related events and quality of life over two years.
You will be asked to confirm your recent experience with an ischemic stroke or transient ischemic attack (TIA) within the last six weeks, your age (70 years or older), and your frailty status.
Step 2
Medication assignment
You will be randomly assigned to either start taking a statin medication or not take any statin. Statins are medications that help lower cholesterol levels in the blood.
If assigned to the statin group, you may receive one of the following medications: Fluvastatine 20 mg (capsules), Simvastatine 40 mg (film-coated tablets), Pravastatine 10 mg (tablets), Atorvastatine 10 mg (film-coated tablets), or Rosuvastatine 5 mg (film-coated tablets). These are taken orally, meaning you swallow them.
Step 3
Medication schedule
If you are in the statin group, you will take your assigned medication once daily. The duration of taking the medication will be for the entire two-year follow-up period.
Step 4
Regular follow-up
You will have regular follow-up appointments at 3, 6, 12, 18, and 24 months. These appointments will help monitor your health and any changes in your condition.
During these follow-ups, your survival without major heart-related events and your quality of life will be assessed. If you joined the study early, there will be an additional follow-up at three years.
Step 5
Health assessments
Your quality of life will be measured using a tool called the Patient-Reported Outcomes Measurement Information System - Global-10 (PROMIS-10).
Other health assessments will include checking for new major cardiovascular events, cognitive function, number of falls, frailty status, and functional outcomes at 12 and 24 months.

Who can join the trial?

4 criteria

Had a recent ischemic stroke or transient ischemic attack (TIA) within the last 6 weeks. An ischemic stroke is when a blood clot blocks a blood vessel in the brain. A TIA is a temporary blockage of blood flow to the brain, often called a "mini-stroke."
Must be 70 years or older at the time of the stroke or TIA.
Considered frail, which means having a score of 4-7 before the event or 6-7 after the event on the Clinical Frailty Scale. This scale measures how much help you need with daily activities.
Not using statin therapy at the time of the stroke or TIA. Statins are medications used to lower cholesterol levels in the blood.

Who cannot join the trial?

4 criteria

Patients who have not had a recent **ischemic stroke** or **transient ischemic attack (TIA)** cannot participate. An ischemic stroke is when a blood clot blocks or narrows an artery leading to the brain. A TIA is a temporary period of symptoms similar to those of a stroke.
Patients who are not **frail** cannot participate. Frail means having a reduced physical strength and health, often due to aging.
Patients who are under the age of **70** cannot participate.
Patients who are part of a **vulnerable population** cannot participate. This means groups of people who might be at a higher risk of harm or exploitation.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Responsive
Sint Franciscus Vlietland Groep Stichting
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Statins are a type of medication used to lower cholesterol levels in the blood. They work by blocking a substance your body needs to make cholesterol, which can help prevent heart attacks and strokes. In this clinical trial, statins are being tested to see if they can improve survival and quality of life in older adults who have had a stroke or a mini-stroke. The goal is to find out if starting statin therapy can help reduce the risk of future heart-related problems in these patients.

What is already known about the treatment

Statins – Statins are medications typically taken orally in the form of tablets. They are widely used in medicine to help lower cholesterol levels in the blood, which can reduce the risk of heart disease and stroke. In the context of this clinical trial, statins are being evaluated for their effectiveness in improving survival and quality of life in older adults who have experienced an ischemic stroke or transient ischemic attack. Statins work by blocking a substance your body needs to make cholesterol, which helps prevent the buildup of cholesterol in the arteries. They belong to a class of drugs known as lipid-lowering agents.

Investigated diseases

Ischemic stroke
Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow. This lack of blood flow results in the deprivation of oxygen and nutrients to brain tissue, leading to the death of brain cells. The progression of an ischemic stroke can vary, with symptoms developing suddenly and potentially worsening over hours. Common symptoms include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, and difficulty walking. The severity and specific symptoms depend on the area of the brain affected. Immediate medical attention is crucial to minimize brain damage.
Transient ischemic attack
A transient ischemic attack (TIA), often called a mini-stroke, occurs when there is a temporary reduction in blood flow to a part of the brain. This results in stroke-like symptoms that typically last for a few minutes to a few hours but do not cause permanent damage. TIAs are often warning signs of a potential future stroke and share similar symptoms, such as sudden numbness, confusion, and difficulty speaking or understanding speech. The symptoms resolve completely within 24 hours, often much sooner. The progression of a TIA is rapid, with symptoms appearing suddenly and resolving quickly. Prompt medical evaluation is important to address underlying risk factors and prevent a full stroke.