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Study on Stopping or Continuing Clopidogrel, Carbasalate Calcium, and Dipyridamole for Young Patients After Stroke Without a Known Cause

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 individuals who have experienced a stroke at a young age, specifically between 18 and 49 years old, without a known cause. The study is investigating the effects of stopping or continuing the use of blood thinners, also known as antiplatelet therapy, which are medications that help prevent blood clots. The medications being studied include Plavix (containing the active substance clopidogrel), Clopidogrel Viatris (also containing clopidogrel), acetylsalicylic acid (commonly known as aspirin), and a combination of dipyridamole and acetylsalicylic acid.

The purpose of the study is to determine whether stopping these blood thinners is as safe and effective as continuing them in preventing major cardiovascular events, such as another stroke or heart attack, three to ten years after the initial stroke. Participants in the study will be randomly assigned to either continue or stop their antiplatelet therapy. Some participants may receive a placebo, which looks like the medication but does not contain any active ingredients. The study will monitor participants over a period of time to observe any major health events, including strokes, heart attacks, or other serious conditions.

Throughout the study, researchers will also assess other factors such as the risk of major bleeding, overall survival, cost-effectiveness, and quality of life. The study aims to provide valuable information on the long-term management of young stroke patients and help guide future treatment decisions. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including having experienced a first ischemic stroke or transient ischemic attack (TIA) with evidence of ischemia on imaging, 3-10 years prior to joining the study.

    Participants must be aged 18-49 at the time of the TIA or ischemic stroke and have no other identified cause after standard medical evaluations.

  2. Step 2

    Medication administration

    Participants will be assigned to either continue or discontinue the use of antiplatelet therapy.

    Medications involved include Plavix 75 mg film-coated tablets and Clopidogrel Viatris 75 mg film-coated tablets, both taken orally.

    The study aims to compare the effects of stopping or continuing these medications on preventing major cardiovascular events.

  3. Step 3

    Monitoring and assessments

    Participants will undergo regular monitoring to assess the occurrence of major vascular events, such as TIA with imaging confirmation, stroke, myocardial infarction, or death from vascular causes.

    Secondary assessments will include monitoring for major bleeding, overall mortality, cost-effectiveness, and quality of life.

  4. Step 4

    Study duration

    The study is expected to continue until September 2, 2031.

    Participants will be involved in the study for a period that aligns with the study's objectives and timelines.

Who can join the trial?

4 criteria

  • You must have had your first-ever **ischaemic stroke** or **TIA** (transient ischaemic attack) with evidence of **ischaemia** (a condition where blood flow and oxygen are reduced) on imaging, 3 to 10 years before joining the study.
  • You should have been between the ages of 18 and 49 at the time of your **TIA** or **ischaemic stroke**.
  • The cause of your stroke should be **cryptogenic**, meaning no other cause was found after a standard medical evaluation. This evaluation includes imaging of the brain and neck arteries, routine blood tests, heart rhythm monitoring for at least 24 hours, and heart ultrasound tests.
  • Both men and women can participate in the study.

Who cannot join the trial?

9 criteria

  • Patients who have had a **stroke** caused by a known reason, not a **cryptogenic stroke**. A cryptogenic stroke is a type of stroke where the cause is unknown.
  • Patients who are not within the age range of 18 to 65 years old.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of severe allergic reactions to medications used in the study.
  • Patients who have a condition that requires them to take medications that cannot be stopped for the study.
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Investigated drugs

Platelet Inhibitors are medications used to prevent blood cells called platelets from clumping together and forming clots. In this trial, they are being studied to see if continuing their use after a cryptogenic stroke in young patients can help prevent major cardiovascular events. These medications are typically prescribed to reduce the risk of stroke or heart attack by keeping the blood flowing smoothly.

What is already known about the treatment

Aspirin – Aspirin is typically administered orally in tablet form. It is widely recognized in medical literature as a common antiplatelet medication used to prevent blood clots. The main therapeutic indication for aspirin is to reduce the risk of stroke and heart attack by preventing platelets in the blood from clumping together. At the molecular level, aspirin works by inhibiting an enzyme called cyclooxygenase, which is involved in the production of substances that promote inflammation and clotting. It is classified pharmacologically as a nonsteroidal anti-inflammatory drug (NSAID) with antiplatelet properties.

Investigated diseases

Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can lead to brain cells beginning to die within minutes. There are two main types of stroke: ischemic, caused by a blockage in an artery, and hemorrhagic, caused by a blood vessel leaking or bursting. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of a stroke can lead to significant brain damage if not addressed quickly. Recovery and effects vary widely depending on the stroke's severity and the speed of treatment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513092-40-00Protocol code114180Estimated enrolment1 366 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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