Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT07035405
Eligibility Criteria:
Inclusion Criteria:
1. An age of 18-80 years old
2. Minor-to-moderate ischemic stroke (NIHSS\<15 at randomization; confirmed by CT or MRI)
3. Within 7-30 days after the most recent qualifying stroke onset
4. Informed consent signed
Exclusion Criteria:
1. Iatrogenic causes (angioplasty or surgery) of stroke
2. mRS\>3 at randomization
3. Known allergy, sensitivity or intolerance to colchicine
4. Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea
5. Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease or with creatine kinase (CK) level \> 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing
6. A history of cirrhosis, chronic active hepatitis or severe hepatic disease
7. Impaired hepatic (ALT or AST \> three times the upper limit of normal range) or kidney (creatinine exceeding 1.5 times of the upper limit of normal range or eGFR less than 50 ml/min) function at randomization
8. Anemia (haemoglobin \<10g/dL), thrombocytopenia (platelet count \<100×109/L) or leucopenia (white blood cell count \<3×109/L) at randomization
9. Comorbid gout or other indications for colchicine use
10. Active infection at randomization (including respiratory tract infection, urinary tract infection, or gastroenteritis)
11. Requiring chronic immunosuppressant, glucocorticoid, or nonsteroidal anti-inflammatory drugs therapy (except aspirin) during the study
12. Usage of contraindicated medications for colchicine at randomization: moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram, etc) or P-gp inhibitors (cyclosporine)
13. Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days
14. Women of childbearing age who were not practicing reliable contraception and did not have a documented negative pregnancy test
15. Severe non-cardiovascular comorbidity, active malignant tumors or terminal-stage illnesses, with a life expectancy of less than 2 years
16. Clinically significant drug or alcohol abuse in the past year
17. Any other conditions deemed unsuitable for participation in this study or inability to complete study procedures, including but not limited to mental disorders, cognitive or emotional impairments, or physical conditions that may compromise compliance with study protocols and follow-up visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07035405
Study Brief:
Protocol Section:
NCT07035405