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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CHU de Liege Liege Belgium
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Frisius Heerenveen The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium
UMCG Groningen The Netherlands
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Amphia Hospital Breda The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
CHC MontLegia Liege Belgium
Vrije Universiteit Brussel Jette Belgium
ETZ Tilburg The Netherlands
Rtuhijkpi Zggyersewi Sukxpghmn Arnhem The Netherlands
Ucul Utrecht The Netherlands
Aw Gcqsqzxsz Kortrijk Belgium
Cbljlysmf Usjymvkyvuapuw Segmkijqr Woluwe-Saint-Lambert Belgium
Cxq da Cvlcvqjsm Hhcqjsd Cxvmg Mvbzf Caluw Charleroi Belgium
Ejimwku Unoslfeqipqh Msgsgfn Couzcuf Rzstonkyl (nqzanca Miw Rotterdam The Netherlands
Lfsqw Uxvrusfaxupq Mxaaygk Cvmjjci (ypbqe Leiden The Netherlands
Ctc Hxkrnm Mons Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.04.2025
The Netherlands The Netherlands
Recruiting
01.04.2025

Trial locations

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).

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 ID:
2024-516188-10-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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  • A study to evaluate the use of diroximel fumarate to reduce brain swelling in patients with a stroke caused by bleeding in the brain.

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