Phase 3 Stroke Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have had a stroke confirmed by brain imaging (MRI or CT scan), with the timing of joining depending on what blood-thinning medication was taken after the stroke
• People who have had a TIA (mini-stroke) lasting 10 minutes or more, with symptoms such as weakness, speech problems, or vision changes, that fully resolved and left no visible damage on brain imaging — but only if a significant narrowing of a nearby artery was also found and treated or confirmed
• People who have a narrowing of at least 30% in an artery supplying the affected area of the brain, such as the carotid artery in the neck, a vertebral or basilar artery, or another brain artery — confirmed by imaging
• People who have a plaque build-up in the large artery (aorta) near the heart, of a certain size or with a clot on top, confirmed by specialised imaging
• People who do not already have a medical reason to take colchicine (such as gout or Mediterranean fever) and who are recommended to take long-term blood-thinning tablet treatment
• People aged 18 or older
• People with a disability score of 4 or less on a standard stroke scale (meaning people who are not fully bedridden or dependent for all care)
• People who have had a full medical examination before joining the trial
• People who have read and signed the informed consent form
• People who hold a social security number
• Women who could become pregnant must be using a highly effective form of contraception, such as combined hormonal contraception or progestogen-only contraception
• Women who could become pregnant must have a negative pregnancy test before joining

Who may not be able to join:

• People who need to take colchicine for another medical condition, such as gout or Mediterranean fever
• People who have had a serious allergic reaction to ticagrelor or any of its ingredients
• People who have had a serious allergic reaction to colchicine or any of its ingredients
• People with significant ongoing digestive problems, such as chronic diarrhoea, uncontrolled ulcerative colitis, or active Crohn's disease
• People with a weakened immune system or bone marrow failure
• People with an active ongoing inflammatory disease, a chronic active infection, or a currently active cancer
• People who are haemodynamically unstable (for example, requiring medication to maintain blood pressure for more than 24 hours, or needing mechanical heart support)
• People who have had a severe infection (sepsis) in the past 7 days, or another serious acute illness recently
• People who have been taking corticosteroids or anti-inflammatory drugs (NSAIDs) long-term (more than 6 months), or in repeated high doses within the past 7 days
• People who need to take certain medications that strongly interact with one of the trial drugs (strong CYP3A4 inhibitors or substrates) and cannot stop those medications during the trial (confirm with trial site)
• People whose stroke or TIA was caused by a torn artery (dissection) or by a heart condition sending clots to the brain, without any evidence of artery narrowing due to plaque build-up
• People who have a medical reason to take long-term blood-thinning tablets such as warfarin or similar drugs (for example, atrial fibrillation)
• People who have had a bleeding stroke with symptoms
• People with active, uncontrolled bleeding
• People with poorly controlled high blood pressure, as assessed by the treating doctor
• People who are unlikely to be able to attend follow-up visits or are expected to have difficulty following the trial requirements
• People with another serious illness that could interfere with the trial results or prevent attendance at visits
• Women who are pregnant or planning to become pregnant at the time of joining
• Women who are currently breastfeeding
• People already taking part in another clinical trial involving an experimental treatment that could interact with aspirin, ticagrelor, or colchicine
• People with a low white blood cell count (below 3,000 per microlitre)
• People with severely reduced kidney function (creatinine clearance below 30 ml/min)
• People with severe liver disease
• People who require any medication that is specifically prohibited in combination with colchicine or ticagrelor

Important: Always verify eligibility with the trial site directly before applying.