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Study on the Effects of Continuing or Stopping Simvastatin and Atorvastatin in Patients with Spontaneous Lobar Intracerebral Hemorrhage

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 is focused on studying the effects of certain medications called statins in patients who have experienced a type of stroke known as intracerebral hemorrhage (ICH). Statins, such as simvastatin and atorvastatin, are commonly used to lower cholesterol levels in the blood. The study aims to understand the impact of continuing or stopping the use of statins on the risk of having another ICH. Additionally, the study will look at the effects of stopping statins on the risk of major heart and blood vessel problems, such as heart attacks and strokes.

Participants in the study will be monitored over a period of 24 months. During this time, researchers will compare the outcomes of those who continue taking statins with those who stop. The study will also assess the quality of life and cognitive functions, which relate to thinking and memory, using tools like the EQ-5D questionnaire and the Telephone Montreal Cognitive Assessment (T-MoCA). The study will also explore the role of certain genetic factors, specifically the APOE gene, in the risk of having another ICH.

The goal of this research is to provide better guidance on the use of statins in patients who have had an ICH, helping to balance the benefits of cholesterol management with the potential risks of recurrent bleeding in the brain. This information could be crucial for doctors and patients in making informed decisions about the continuation or discontinuation of statin therapy after an ICH.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. This includes being 50 years or older, having a spontaneous lobar intracerebral hemorrhage (ICH) confirmed by a CT or MRI scan, and having been on a statin drug at the time of the ICH.

    Randomization occurs within 7 days of the ICH onset. Agreement to be randomized to either continue or discontinue statin use is required.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: statin continuation or statin discontinuation.

    The purpose is to compare the effects of continuing versus stopping statin use on the risk of recurrent ICH and other health events.

  3. Step 3

    Medication administration

    If assigned to the statin continuation group, participants will continue taking their prescribed statin medication. This could be one of the following: Simvastatin 10 mg, 20 mg, or 40 mg, or Atorvastatin 10 mg, 20 mg, 40 mg, or 60 mg. All medications are taken orally as film-coated tablets.

    If assigned to the statin discontinuation group, participants will stop taking their statin medication.

  4. Step 4

    Follow-up period

    The follow-up period lasts for 24 months. During this time, the effects of continuing or discontinuing statins on the risk of recurrent symptomatic ICH and major adverse cardiac and cerebrovascular events (MACCE) are monitored.

    MACCE includes events such as ischemic stroke, myocardial infarction, and vascular death.

  5. Step 5

    Assessment of outcomes

    Primary outcomes focus on the risk of recurrent ICH and the occurrence of MACCE.

    Secondary outcomes include quality of life, cognitive and functional outcomes, assessed through questionnaires and scales such as the EQ-5D, modified Rankin Scale (mRS), and Telephone Montreal Cognitive Assessment (T-MoCA).

    The study also examines the effects of specific genetic factors on the risk of recurrent ICH.

Who can join the trial?

5 criteria

  • Must be **50 years old or older**.
  • Must have had a **spontaneous lobar ICH**, which is a type of bleeding in the brain, confirmed by a **CT or MRI scan**. These are special imaging tests that take pictures of the inside of your body.
  • Must have been taking a **statin drug** at the time the brain bleeding started. Statins are medications used to lower cholesterol.
  • Must be able to start the study within **7 days** of the brain bleeding event.
  • Must agree, after talking with the doctors who prescribed the statin, to be randomly assigned to either continue or stop taking the statin.

Who cannot join the trial?

4 criteria

  • Patients who have not experienced a spontaneous lobar ICH (a type of bleeding in the brain that occurs without any obvious cause).
  • Patients who are not currently taking a statin drug (a medication used to lower cholesterol levels).
  • Patients who are under the age of 18.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Statins are medications 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 disease and stroke. In this clinical trial, the focus is on understanding the effects of continuing or stopping statins in patients who have experienced a type of stroke called intracerebral hemorrhage. The trial aims to see if stopping statins reduces the risk of having another stroke and to assess the safety of stopping statins in terms of other heart and blood vessel problems.

What is already known about the treatment

Statins – Statins are typically administered orally in the form of tablets. They are widely used in medicine to manage cholesterol levels and reduce the risk of cardiovascular events. In the context of this clinical trial, statins are being studied for their effects on patients with spontaneous lobar intracerebral hemorrhage (ICH). The main therapeutic indication is to assess the impact of continuing versus discontinuing statins on the recurrence of ICH and major adverse cardiac and cerebrovascular events. Statins work by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in cholesterol production in the liver. They are classified as lipid-lowering agents.

Investigated diseases

Spontaneous Lobar Intracerebral Hemorrhage (ICH) – This condition involves bleeding within the brain's lobes, occurring without any apparent cause such as trauma. It typically results from the rupture of small blood vessels, often linked to high blood pressure or amyloid angiopathy. The bleeding can lead to increased pressure in the brain, causing symptoms like sudden headache, weakness, or changes in vision or speech. As the hemorrhage progresses, it may result in more severe neurological deficits, depending on the location and size of the bleed. Over time, the body may reabsorb the blood, but the initial damage can lead to lasting impairments. The risk of recurrence is a significant concern, especially in individuals with underlying conditions that predispose them to bleeding.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511465-11-00Protocol codeSATURNEstimated enrolment1 456 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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