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Study on Stopping Atorvastatin in Frail Patients Aged 70+ with Recent Ischemic Stroke or Transient Ischemic Attack

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial, known as SAFEST, is focused on studying the effects of stopping or not starting the use of statins in older patients who have experienced a recent ischemic stroke or transient ischemic attack (TIA). Statins, such as atorvastatin, are medications commonly used to lower cholesterol levels in the blood. The study aims to understand whether the daily functioning and quality of life of patients aged 70 and older improve when statins are not used, compared to when they are used.

Participants in this study will be monitored over a period of two years. The main focus will be on assessing their daily activities and overall health-related quality of life. These aspects will be evaluated using specific surveys designed to measure how well patients are able to perform daily tasks and their mental and physical health. The study will also look at other factors such as physical functioning, emotional well-being, and any side effects from medications. Additionally, it will track the occurrence of any new cardiovascular events, like heart attacks or strokes, and overall survival rates.

The goal of this research is to provide valuable insights into the potential benefits or drawbacks of using statins in older, frail patients who have had a stroke or TIA. By understanding these effects, healthcare providers can make more informed decisions about the best treatment options for this specific group of patients. The study will help determine if stopping or not starting statins can lead to better health outcomes and quality of life for these individuals.

The research process

The trial runs in 6 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, eligibility is confirmed based on age and recent medical history. Participants must be 70 years or older and have experienced an ischemic stroke or transient ischemic attack within the last six weeks. Frailty is assessed using a specific scale.
Step 2
Initial assessment
An initial assessment is conducted to evaluate daily functioning and quality of life. This involves completing surveys designed to measure these aspects.
Step 3
Medication administration
Participants may be assigned to take atorvastatin, a medication in the form of a 10 mg film-coated tablet, taken orally. The frequency and duration of administration are determined by the study protocol.
Step 4
Ongoing monitoring
Throughout the study, regular check-ins are scheduled to monitor health status, including physical and cognitive functioning, emotional well-being, and any adverse effects from medication.
Step 5
One-year evaluation
After one year, a comprehensive evaluation is conducted to assess daily functioning and health-related quality of life. Additional assessments may include physical functioning, cognition, and cardiovascular health.
Step 6
Two-year evaluation
At the end of two years, a final evaluation is performed. This includes measuring daily functioning and quality of life, as well as reviewing any changes in health status, including the occurrence of cardiovascular events.

Who can join the trial?

3 criteria

Must be 70 years or older at the time of the ischemic stroke or transient ischemic attack (TIA).
Must join the study within 6 weeks after being diagnosed with an ischemic stroke or TIA.
Must be considered frail. Frailty is measured using a tool called the Clinical Frailty Scale. You need a score of 4-7 before the stroke or TIA, or a score of 6-7 after the event.

Who cannot join the trial?

3 criteria

Patients who have had an ischemic stroke or a transient ischemic attack (often called a mini-stroke) cannot participate.
Patients who are younger than 70 years old cannot participate.
Patients who are not considered frail (meaning they are not weak or have reduced strength) cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Catharina Ziekenhuis Stichting
Verified
Eindhoven, The Netherlands
Gelre Hospitals
Verified
Zutphen, The Netherlands
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Statins are a type of medication that helps 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, the role of statins is to see if stopping them or not starting them at all can improve daily functioning and quality of life in older patients who have had a recent stroke or a mini-stroke.

Atorvastatin

What is already known about the treatment

Statins – Statins are typically administered orally in the form of tablets or capsules. They are widely recognized in medical literature as a class of drugs used to lower cholesterol levels in the blood, which can help prevent heart disease and stroke. The main therapeutic indication for statins is to reduce the risk of cardiovascular events, such as heart attacks and strokes, particularly in individuals with high cholesterol or existing heart conditions. At the molecular level, statins work by inhibiting an enzyme in the liver called HMG-CoA reductase, which plays a crucial role in the production of cholesterol. This pharmacological classification places statins in the category of 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 blockage prevents brain tissue from receiving oxygen and nutrients, leading to the death of brain cells within minutes. 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. Recovery and progression can vary widely among individuals.
Transient ischemic attack
A transient ischemic attack (TIA) is often referred to as a mini-stroke and occurs when there is a temporary reduction in blood flow to 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. The symptoms of a TIA are similar to those of a stroke, including sudden numbness, confusion, and difficulty with speech or balance. Unlike a full stroke, the symptoms of a TIA resolve completely within 24 hours. TIAs are often warning signs of potential future strokes. The progression involves a brief interruption of blood flow, with symptoms resolving as normal circulation resumes.