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Study of clopidogrel and acetylsalicylic acid (aspirin) for prevention of cardiovascular events in patients who survived intracerebral hemorrhage stroke

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 study focuses on patients who have experienced an intracerebral hemorrhage, which is a type of stroke where bleeding occurs inside the brain tissue. The research examines the effectiveness of antiplatelet therapy using two medications: clopidogrel (75 mg daily) and acetylsalicylic acid (80 mg daily), which are drugs that help prevent blood clots from forming.

The purpose of this research is to determine whether starting oral antiplatelet medication alone is more beneficial than avoiding these medications in preventing future cardiovascular and brain-related health events in people who have survived a brain hemorrhage. The study compares two groups of patients - one group receiving antiplatelet medication and another group receiving standard care without antiplatelet medication.

The treatment period lasts for 60 months, during which patients will take their assigned medication daily. Throughout the study, doctors will monitor patients for various health events, particularly focusing on strokes, heart attacks, and other cardiovascular conditions. The medications are taken as tablets by mouth once daily.

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

    Initial qualification

    You must be at least 18 years old and have experienced a stroke caused by brain bleeding (intracerebral hemorrhage), confirmed by brain imaging

    The stroke must have occurred at least 24 hours before joining the study

    Your brain imaging report must be available for review

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two groups:

    Group 1: Taking oral antiplatelet medication (either Clopidogrel 75 mg film-coated tablets or Acetylsalicylic acid 80 mg tablets)

    Group 2: No antiplatelet medication

  3. Step 3

    Treatment period

    The study will continue from April 2025 to April 2029

    You will take the assigned medication orally according to the prescribed schedule

    You will receive standard care at your participating hospital throughout the study period

  4. Step 4

    Health monitoring

    Your health will be monitored for the following main events:

    - Hospital visits due to stroke or heart attack

    - Heart and blood vessel related health issues

    - Any major bleeding events requiring hospital care

    - Emergency room visits for heart or blood vessel related problems

    These events will be recorded and analyzed to evaluate the effectiveness of the treatment

  5. Step 5

    Study completion

    The study will end in April 2029

    Your participation will help determine whether antiplatelet medication is beneficial for patients who have experienced brain bleeding

Who can join the trial?

5 criteria

  • Patient must have experienced a stroke caused by bleeding in the brain (intracerebral hemorrhage), confirmed by brain imaging, with symptoms starting at least 24 hours before joining the study
  • Patient must be 18 years or older when the brain bleeding was first diagnosed through imaging
  • The written report of the brain imaging that first diagnosed the bleeding must be available
  • Patient must provide informed consent to participate in the study (if patient is unable to make decisions, a legal representative can provide consent)
  • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years old or above 65 years old
  • Inability to provide informed consent
  • Known allergy or hypersensitivity to antiplatelet medications (drugs that help prevent blood clots)
  • Current active bleeding from any source
  • Pregnancy or breastfeeding
  • Participation in other clinical trials
  • Life expectancy less than 6 months due to other medical conditions
  • Recent major surgery within the past 30 days
  • Severe liver disease or kidney failure requiring dialysis
  • History of blood clotting disorders
  • Current use of blood thinning medications (such as warfarin or similar drugs)
  • Planned surgery in the next 6 months
  • Previous severe reactions to medications similar to those used in the study
  • Inability to follow study procedures or attend follow-up visits
  • Severe uncontrolled high blood pressure
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Investigated drugs

Based on the provided trial information, the main medication involved is: Antiplatelet - This is a type of medication that helps prevent blood clots by stopping blood platelets from sticking together. It is commonly used to reduce the risk of heart attacks and strokes. In this trial, it is being studied as a preventive treatment for patients who have previously experienced bleeding in the brain (intracerebral hemorrhage).

What is already known about the treatment

Antiplatelet agents - These are medications that help prevent blood clots by reducing the ability of platelets to stick together. In this clinical trial, they are being studied as oral medications for patients who have survived an intracerebral hemorrhage (brain bleeding). These drugs belong to the pharmacological class of blood thinners and work by interfering with platelet aggregation at the molecular level by blocking specific receptors on platelet surfaces. The main therapeutic indication being investigated is the prevention of major adverse cardiovascular or cerebrovascular events in patients who have previously experienced brain hemorrhage, representing a careful balance between preventing new blood clots while managing bleeding risks. Note: Since specific antiplatelet medications are not named in the source data, I provided a general description of the drug class being studied in this trial.

Investigated diseases

  • Intracerebral hemorrhage

    A condition where blood suddenly bursts into brain tissue, causing damage to the brain. It occurs when a blood vessel within the brain becomes weak and ruptures, allowing blood to leak into and around brain cells. The bleeding causes brain tissue to swell, resulting in pressure building up inside the skull. This condition can affect various parts of the brain, with symptoms depending on the location and size of the bleeding. The accumulated blood can irritate and damage brain tissue, potentially affecting various brain functions.

  • Myocardial infarction

    A serious condition where blood flow to part of the heart muscle becomes blocked, causing damage to heart tissue. The blockage typically occurs when a blood clot forms in one of the heart's arteries, preventing oxygen-rich blood from reaching heart muscle cells. Without adequate blood flow, the affected heart muscle begins to die. The severity depends on the size of the damaged area and the length of time blood flow is restricted.

  • Pulmonary embolism

    A condition where a blood clot becomes lodged in one of the arteries in the lungs. The clot typically forms in the deep veins of the legs and travels through the bloodstream to the lungs. When the clot blocks a pulmonary artery, it prevents blood from flowing to a portion of the lung. This reduces oxygen levels in the blood and can strain the heart as it tries to pump against the blockage.

  • Ischemic stroke

    A condition where blood flow to part of the brain is blocked by a clot or narrowed blood vessel. Without blood supply, brain cells in the affected area begin to die from lack of oxygen. The impact of the stroke depends on which part of the brain is affected and how long the blood flow is blocked. The blocked blood flow can cause various symptoms depending on the affected brain region.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516188-10-00Estimated enrolment4 388 patientsSponsorUniversity Of Edinburgh

sourced from the EU Clinical Trials Register and site verification

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