Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage

Korábbi kezelés

• 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);
• Recent participation in any other interventional study in the past 30 days before enrollment;

Más betegség

• Known allergy, sensitivity or intolerance to colchicine;
• Any condition in which investigators believe that participating in this study may be harmful to the patient.

Laborértékek

• 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]);

Egyéb

• Secondary causes of ICH;
• Contraindications or inability to complete brain MRI or susceptibility weighted imaging (SWI) scans;
• Pregnancy or breastfeeding;
• Not expected to survive the follow-up period;
• Inability to adhere to study procedures;

• 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.