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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT07026994
Eligibility Criteria:
Inclusion Criteria:
* Age ≥55 years;
* Diagnosed with "probable CAA with supporting pathology" or "probable CAA" according to the modified Boston criteria (version 1.5);
* High risk of recurrent ICH, defined as: 1 prior symptomatic ICH and presence of cortical superficial siderosis (cSS), or ≥2 prior symptomatic ICHs;
* Time interval since symptom onset of the most recent ICH: ≤3 months (earlier enrollment is preferred if criteria are met);
* Modified Rankin Scale (mRS) score ≤4 at randomization;
* Written informed consent from the participant or their legally authorized representative before study enrollment.
Exclusion Criteria:
* Secondary causes of ICH;
* Pre-existing moderate-to-severe renal, liver or blood disorders (anaemia \[hemoglobin \<10g/dL\], thrombocytopaenia \[platelet count \<100×109/L\], leucopenia \[white blood cell \<3×109/L\], cirrhosis or severe hepatic dysfunction, renal insufficiency \[estimated glomerular filtration rate (eGFR) \<15mL/min\]);
* Prior diagnosis of gout, peripheral neuropathy, myopathy, inflammatory bowel disease or chronic diarrhea;
* Concurrent treatment with regular immune-suppressant (corticosteroids, cyclophosphamide, azathioprine, mycophenolate mofetil, rituximab), moderate-to-strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine);
* Known allergy, sensitivity or intolerance to colchicine;
* Contraindications or inability to complete brain MRI or susceptibility weighted imaging (SWI) scans;
* Pregnancy or breastfeeding;
* Recent participation in any other interventional study in the past 30 days before enrollment;
* Not expected to survive the follow-up period;
* Inability to adhere to study procedures;
* Any condition in which investigators believe that participating in this study may be harmful to the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT07026994
Study Brief:
Protocol Section:
NCT07026994