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Study on Colchicine and Ticagrelor for Preventing Ischemic Stroke in Patients with Atherosclerosis

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 on preventing further health issues in patients who have experienced an ischemic stroke or have conditions like atherosclerosis, which is a build-up of fats, cholesterol, and other substances in and on the artery walls. The study involves the use of two medications: Colchicine, which is often used to treat inflammation, and Ticagrelor, also known by its code name AZD6140, which helps prevent blood clots. These medications are being tested to see if they can reduce the risk of having another stroke or other major heart-related events.

The purpose of the study is to evaluate how effective low doses of Colchicine and Ticagrelor are in reducing the chances of having another major vascular event, such as a stroke or heart attack. Participants in the study will take these medications over a period of time, and their health will be monitored to see if the medications help in preventing further issues. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, participants will be asked to take the medications as directed and attend regular check-ups to monitor their health. The study aims to provide valuable information on whether these medications can be a beneficial treatment option for people at high risk of recurrent strokes or heart problems. The results could help in developing better prevention strategies for those with a history of ischemic stroke or related conditions.

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

    Upon joining the study, a medical examination is conducted to confirm eligibility. This includes verifying a history of cerebral infarction, transient ischemic attack (TIA), or other related conditions through neuro-imaging such as MRI or CT scans.

    For women of childbearing potential, a pregnancy test is required, and effective contraception must be used during the study.

  2. Step 2

    Initial treatment phase

    The treatment involves taking colchicine and ticagrelor. Colchicine is administered in low doses, while ticagrelor is taken at a dosage of 90 mg twice daily (b.i.d.).

    The medications are taken orally in the form of tablets or oral solutions.

  3. Step 3

    Ongoing treatment and monitoring

    The treatment continues for a period ranging from 36 to 60 months. During this time, regular monitoring is conducted to assess the effectiveness of the treatment in preventing major vascular events.

    Monitoring includes checking for any recurrent strokes, myocardial infarctions, or other vascular events.

  4. Step 4

    End of study

    The study is estimated to conclude by May 17, 2028. At the end of the study, a final assessment is conducted to evaluate the long-term efficacy of the treatment in reducing the risk of recurrent major vascular events.

Who can join the trial?

12 criteria

  • Must have had a cerebral infarction (a type of stroke) confirmed by brain imaging tests like MRI or CT scan.
  • Must have a medical check-up before joining the study.
  • If capable of having children, must use effective birth control methods.
  • Women who can have children must take a pregnancy test.
  • Must have documented atherosclerotic stenosis (narrowing of arteries due to plaque buildup) in certain arteries, confirmed by specific imaging tests.
  • Or have a history of coronary artery disease (heart disease).
  • Or have had a transient ischemic attack (TIA) lasting 10 minutes or more, with full recovery and no brain damage seen on imaging tests.
  • Must not have a clear need for colchicine treatment (a medication for certain conditions) and should need long-term antiplatelet therapy (medication to prevent blood clots).
  • Must be 18 years old or older.
  • Must have a Rankin score of less than 4, which means they can manage most daily activities with some help.
  • Must fully understand and sign a consent form agreeing to participate.
  • Must have a social security number.

Who cannot join the trial?

8 criteria

  • Patients with a history of **stroke** (a condition where blood flow to the brain is interrupted).
  • Patients with **ischemic** conditions (related to reduced blood flow).
  • Patients who have experienced a **TIA** (Transient Ischemic Attack, often called a mini-stroke).
  • Patients with any form of **cardiac disease** (heart-related conditions).
  • Patients with **atherosclerosis** (a condition where arteries become narrowed and hardened).
  • Patients who have had a **myocardial infarction** (commonly known as a heart attack).
  • Patients with **coronary syndrome** (a range of conditions related to sudden reduced blood flow to the heart).
  • Patients who have experienced a **cerebral infarction** (a type of stroke caused by a blockage in the blood vessels supplying the brain).
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Investigated drugs

  • Colchicine

    is a medication used in this trial to help reduce inflammation. It is being evaluated for its ability to prevent ischemic strokes in patients who have already experienced a stroke due to atherosclerosis. The goal is to see if it can lower the risk of having another major vascular event.

  • Ticagrelor

    is another medication involved in the trial. It is used to prevent blood clots and is being tested for its effectiveness in reducing the risk of recurrent strokes in high-risk patients. The study aims to determine if ticagrelor can help prevent further major vascular events in these individuals.

What is already known about the treatment

  • Colchicine

    Colchicine is administered orally in tablet form. It is currently being studied for its potential to reduce inflammation in patients who have experienced an ischemic stroke due to atherosclerosis. The main therapeutic indication is to prevent recurrent major vascular events by reducing inflammation. At the molecular level, colchicine works by inhibiting microtubule polymerization, which decreases the activity of inflammatory cells. It is classified as an anti-inflammatory medication.

  • Ticagrelor

    Ticagrelor is taken orally in tablet form, typically at a dose of 90 mg twice daily. It is being evaluated for its effectiveness in preventing ischemic strokes in patients with a history of atherosclerosis. The primary therapeutic use is to reduce the risk of recurrent major vascular events. Ticagrelor functions by inhibiting platelet aggregation, which helps prevent blood clots. It is classified as an antiplatelet agent.

Investigated diseases

  • Ischemic Stroke

    This condition occurs when a blood clot blocks or narrows an artery leading to the brain, reducing blood flow and oxygen. It can cause sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression can lead to brain damage if not addressed promptly.

  • Transient Ischemic Attack (TIA)

    Often called a mini-stroke, TIA is a temporary period of symptoms similar to those of a stroke. It occurs when blood flow to part of the brain is blocked for a short time. Symptoms usually last less than 24 hours and do not cause permanent damage.

  • Cardiac Disease

    This term encompasses a range of heart-related conditions, including coronary artery disease, heart rhythm problems, and heart defects. It often involves narrowed or blocked blood vessels that can lead to chest pain or heart attacks. Over time, it can weaken the heart and affect its ability to pump blood efficiently.

  • Atherosclerosis

    A condition where arteries become narrowed and hardened due to a buildup of plaque around the artery wall. It can restrict blood flow and lead to serious problems like heart attacks or strokes. The disease progresses slowly and can start as early as childhood.

  • Myocardial Infarction

    Commonly known as a heart attack, this occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. Symptoms include chest pain, shortness of breath, and discomfort in the upper body. The damage can affect the heart's ability to function properly.

  • Coronary Syndrome

    This term refers to a range of conditions associated with sudden, reduced blood flow to the heart. It includes heart attacks and unstable angina. Symptoms can include chest pain, nausea, and shortness of breath, and it requires immediate medical attention.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513669-38-00Protocol codeAPHP211055Estimated enrolment1 400 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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