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Testing personalized treatment with acetylsalicylic acid, clopidogrel, and ticlopidine to prevent another stroke in patients with ischemic 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 is looking at people who have had a non-cardioembolic ischemic stroke, which is a type of stroke caused by a blocked blood vessel in the brain that is not related to heart rhythm problems. The study will test three different medications that help prevent blood clots: ticlopidine hydrochloride, clopidogrel, and acetylsalicylic acid (also known as aspirin). These medications work by preventing small blood cells called platelets from sticking together and forming clots. The purpose of the study is to show that choosing the right antiplatelet drug for each person based on their individual characteristics can reduce the number of major heart and blood vessel problems that happen within 12 months, compared to the standard way of prescribing these medications.

People in this study will have had their stroke within the past two weeks and will be taking either one or two antiplatelet medications as part of their treatment to prevent another stroke. The study will compare different approaches to selecting which antiplatelet medication works best for each person. During the study, participants will be followed for 12 months, with check-ups at 3 months and 12 months to see how well they are taking their medication and how well the medication is working. The study will also look at whether there are differences in how men and women respond to these treatments.

The main thing researchers will measure is how many people have another stroke, a heart attack, or die from heart-related causes within 12 months. They will also look at whether people have any bleeding problems, how well people stick to taking their medication, and how well people can function in their daily lives after 12 months. The study will examine genetic factors that might affect how people respond to these medications and will track all major health events that occur during the treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and treatment assignment

    Your participation in this trial begins within 14 days after experiencing a non-cardioembolic ischemic stroke. This type of stroke occurs when blood flow to the brain is blocked, but not due to heart-related blood clots.

    You will be assigned to receive either a tailored antiplatelet treatment or usual care. Antiplatelet drugs are medications that help prevent blood clots by stopping platelets in your blood from sticking together.

    The treatment may include one or two antiplatelet medications, depending on your assigned group.

  2. Step 2

    Starting medication

    You will begin or continue taking antiplatelet medication after your stroke. The specific medication and dosage will depend on your treatment assignment.

    Possible medications include: ticlopidine hydrochloride 250 mg tablets taken by mouth, clopidogrel 75 mg tablets taken by mouth, or acetylsalicylic acid (also known as aspirin) 100 mg tablets taken by mouth.

    Your doctor will inform you about the specific medication, dosage, and frequency you need to follow.

  3. Step 3

    3-month follow-up visit

    At 3 months after starting the trial, you will attend a follow-up visit.

    During this visit, your adherence to the medication will be assessed. This means checking how well you have been taking your prescribed medication.

    You will complete a questionnaire called the Medication Adherence Report Scale, which consists of 5 questions about your medication-taking habits.

    A blood test called an aggregation test may be performed to measure how well the medication is working in your body.

  4. Step 4

    Ongoing treatment period

    You will continue taking your assigned antiplatelet medication daily throughout the trial period.

    The total treatment duration is 12 months.

    During this time, any cardiovascular events such as stroke, heart attack, or bleeding complications will be monitored and recorded.

  5. Step 5

    12-month follow-up visit

    At 12 months after starting the trial, you will attend a final follow-up visit.

    Your adherence to medication will be assessed again using the same questionnaire and blood test as at 3 months.

    Your functional status will be evaluated using the modified Rankin Scale, which measures your level of disability or dependence in daily activities. The scale ranges from 0 (no symptoms) to 6 (death).

    Any cardiovascular events that occurred during the 12-month period, including stroke, heart attack, cardiovascular death, or bleeding episodes, will be reviewed and documented.

  6. Step 6

    End of trial participation

    Your active participation in the trial ends after the 12-month follow-up visit.

    All information collected during your participation will be analyzed to determine whether tailored antiplatelet treatment reduces the risk of cardiovascular events compared to usual care.

Who can join the trial?

5 criteria

  • You must be 18 years old or older
  • Both men and women can participate
  • You must have had a non-cardioembolic ischemic stroke within the past 14 days. This means a stroke caused by a blocked blood vessel in the brain, but not caused by a blood clot coming from the heart
  • You must be starting or continuing secondary prevention treatment with antiplatelet therapy. Secondary prevention means treatment to prevent another stroke from happening. Antiplatelet therapy refers to medicines that help prevent blood clots, and you may be taking one or two of these medicines
  • You must be able to provide written informed consent, which means signing a document showing you agree to participate in the study after understanding what it involves. If you are unable to provide consent yourself, it may be obtained according to your country's laws

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this clinical trial
  • Exclusion criteria typically include things like other medical conditions, certain medications being taken, pregnancy status, or recent medical procedures, but none are specified in the provided information
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Investigated drugs

Antiplatelet drugs are medications that help prevent blood cells called platelets from sticking together and forming clots. In this trial, doctors will choose which antiplatelet medication is best for each patient based on their individual needs. These drugs are used to help prevent another stroke or other heart and blood vessel problems in people who have already had a stroke that was not caused by a heart rhythm problem.

What is already known about the treatment

Antiplatelet drugs – Antiplatelet drugs are medications that prevent blood cells called platelets from sticking together and forming clots in blood vessels. These medicines are commonly used after a stroke caused by blocked blood vessels (not related to heart rhythm problems) to prevent another stroke from happening. They work by blocking specific proteins on the surface of platelets that normally help them clump together, making the blood less likely to form dangerous clots. In this clinical trial, doctors are testing whether choosing the specific type of antiplatelet drug based on each patient's individual characteristics can better prevent future heart attacks and strokes compared to standard treatment approaches.

Investigated diseases

Non-cardioembolic Ischemic Stroke – This is a type of stroke that occurs when blood flow to part of the brain is blocked by a blood clot that does not originate from the heart. The blockage typically forms in the blood vessels of the brain itself or in the arteries leading to the brain due to fatty deposits and other substances building up on vessel walls. When brain cells are deprived of oxygen and nutrients due to reduced blood flow, they begin to die within minutes. Common symptoms include sudden weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, and loss of balance or coordination. The severity of the stroke depends on which area of the brain is affected and how long the blood flow is interrupted. After the initial event, patients may experience varying degrees of physical and cognitive impairment that can improve over time with rehabilitation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523065-16-00Protocol codeTAILOR trialEstimated enrolment1 506 patientsSponsorAzienda Unita Sanitaria Locale Di Bologna

sourced from the EU Clinical Trials Register and site verification

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