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

Launched by HUASHAN HOSPITAL · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called colchicine is safe and easy to take for people who have had a type of brain bleed called intracerebral hemorrhage (ICH) caused by a condition called cerebral amyloid angiopathy (CAA). The goal is to see if colchicine can help prevent these brain bleeds from happening again in people who are at high risk. Researchers will compare colchicine to a placebo (a harmless pill with no medicine) to check its safety and how well patients tolerate it over a year.

People who might join this study are adults aged 55 or older who have had at least one previous brain bleed related to CAA and are considered at high risk of having another. Participants will take either colchicine or the placebo every day for 12 months. They will have phone check-ins at 3 and 9 months, and in-person visits at 6 and 12 months for tests and health checkups. They will also be encouraged to control their blood pressure and follow a healthy lifestyle. It’s important to know that this study is not recruiting yet, and certain health conditions or medications may exclude someone from joining. Overall, this trial aims to find a new way to help prevent serious brain bleeds in people with CAA.

Gender

ALL

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.