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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Les Hopitaux De Chartres Le Coudray France
Centre Hospitalier William Morey Chalon Sur Saone France
Centre Hospitalier General Gonesse France
Centre Hospitalier Du Puy Le Puy-En-Velay France
Fondation A De Rothschild Paris France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
HIA Sainte Anne Toulon France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier De Dax Dax France
Hopital Prive Clairval Marseille France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier De Saint-Denis St Denis France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Centre Hospitalier Saint Nazaire St Nazaire France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
17.05.2023

Trial locations

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.

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.

Cerebral Infarction – This is a type of ischemic stroke where a blockage in the blood vessels leads to the death of brain tissue. It can result in loss of neurological function depending on the area of the brain affected. Symptoms may include sudden weakness, speech difficulties, and vision problems.

Trial ID:
2024-513669-38-00
Protocol code:
APHP211055
NCT ID:
NCT05476991
Trial Phase:
Therapeutic confirmatory (Phase III)

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