Actively Recruiting
Reducing Inflammation in Ischemic Stroke With Colchicine and Ticagrelor in High-Risk Patients - Extended Treatment in Ischemic Stroke
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-08
2800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of low-dose colchicine and ticagrelor to reduce the risk of major vascular events in patients who have had an ischemic stroke due to atherosclerosis. This study tests whether adding colchicine (0.5 mg/day) to standard medical care can lower the risk of problems like stroke and heart attack over 36 to 60 months. It also compares ticagrelor (90 mg twice daily) with aspirin to see which better reduces long-term vascular risks in these patients. Participants are randomly assigned to one of four groups combining colchicine or no colchicine with ticagrelor or aspirin. Treatment lasts from 36 to 60 months. The study is designed to observe differences in vascular event rates among these groups. Colchicine is studied for its anti-inflammatory effects, while ticagrelor and aspirin are antiplatelet medications that affect blood clotting. During the study, participants will undergo regular check-ups and monitoring for events such as ischemic stroke, myocardial infarction, and vascular death. The primary outcomes focus on occurrences of these events over 36 months. Secondary outcomes include recurrent strokes, coronary events, and revascularization procedures. Safety and adherence will be monitored throughout the treatment period, which may last up to five years.
CONDITIONS
Brief Title
Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with cerebral infarction confirmed by MRI or CT after neurological stability
- Or diagnosed with transient ischemic attack lasting 10 minutes or more with specific symptoms and relevant imaging
- Documented atherosclerotic stenosis of carotid or cerebral arteries or aortic arch plaque meeting specified criteria
- No current indication for colchicine treatment (e.g., gout, Mediterranean fever)
- Indication for long-term antiplatelet therapy without oral anticoagulant
- Modified Rankin score less than or equal to 4
- Fully informed and signed consent
- Possession of social security number
- Medical examination before participation
- Use of highly effective contraception if of childbearing potential
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Need for colchicine treatment (e.g., gout, Mediterranean fever)
- Hypersensitivity to ticagrelor, colchicine, or their excipients
- Major digestive disorders including chronic diarrhea or uncontrolled inflammatory bowel disease
- Immunosuppression or bone marrow failure
- Active chronic inflammatory disease, chronic infection, or evolving cancer
- Hemodynamic instability requiring prolonged circulatory support
- Recent severe sepsis or acute events within 7 days
- Long-term corticosteroid or NSAID treatment exceeding 6 months
- Use of strong CYP3A4 inhibitors or substrates that cannot be stopped
- Stroke or TIA due to arterial dissection or non-atherosclerotic cardiac sources without documented atherosclerosis
- Indication for long-term oral anticoagulant treatment
- Symptomatic hemorrhagic stroke or active bleeding
- Uncontrolled hypertension
- Inability to attend follow-up visits or expected poor compliance
- Intercurrent disease interfering with study evaluation
- Anticipated pregnancy or breastfeeding
- Participation in another experimental pharmacotherapy affecting study drugs
- Leukopenia below 3000/µl
- Severe renal impairment with creatinine clearance below 30 ml/min
- Severe hepatic impairment
- Use of treatments contraindicated with colchicine or ticagrelor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 to 60 months
Participants receive low-dose colchicine and/or ticagrelor or aspirin as part of the study to reduce the risk of major vascular events after ischemic stroke due to atherosclerosis.
Regular visits during treatment to monitor health and medication effects
Trial Site Locations
Total: 1 location
1
URC Lariboisière-Fernand Widal-Saint Louis
Paris, Paris, France, 75010
Actively Recruiting
Research Team
P
Pierre Amarenco, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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