Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05476991

Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-08

2800

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.

CONDITIONS

Official Title

Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Confirmed cerebral infarction (stroke) by MRI or CT after stabilization or documented TIA with specific symptoms and carotid or intracranial stenosis treated or present
  • Documented atherosclerotic stenosis of carotid, cerebral arteries, or aortic arch plaque as defined by imaging reports
  • No current indication for colchicine treatment (such as gout or Mediterranean fever)
  • Indicated for long-term antiplatelet therapy without oral anticoagulant indication
  • Rankin score less than or equal to 4
  • Fully informed and signed informed consent
  • Possession of a social security number
  • Medical examination prior to participation
  • Use of highly effective contraception if of childbearing potential
  • Pregnancy test for women of childbearing potential
Not Eligible

You will not qualify if you...

  • Need for colchicine treatment (e.g., gout, Mediterranean fever)
  • Allergic reactions to ticagrelor or colchicine or their components
  • Major digestive disorders such as chronic diarrhea or active inflammatory bowel disease
  • Immunosuppression or medullary aplasia
  • Active chronic inflammatory disease, infection, or progressing cancer
  • Hemodynamic instability requiring prolonged support
  • Recent severe sepsis or acute severe illnesses
  • Chronic corticosteroid or NSAID treatment over 6 months or repeated high doses
  • Planned use of strong CYP3A4 inhibitors or substrates that cannot be stopped
  • Stroke or TIA caused by arterial dissection or cardiac embolism without atherosclerosis
  • Indication for long-term oral anticoagulant treatment
  • Symptomatic hemorrhagic stroke
  • Active pathological bleeding
  • Uncontrolled high blood pressure
  • Inability to attend follow-up visits or expected poor compliance
  • Intercurrent diseases interfering with study evaluation
  • Anticipated pregnancy or breastfeeding
  • Participation in other experimental pharmacotherapy affecting study drugs
  • Leukopenia below 3000/μl
  • Severe kidney impairment (creatinine clearance below 30 ml/min)
  • Severe liver impairment
  • Use of treatments contraindicated with colchicine or ticagrelor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

URC Lariboisière-Fernand Widal-Saint Louis

Paris, Paris, France, 75010

Actively Recruiting

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Research Team

P

Pierre Amarenco, Pr

CONTACT

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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