Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCe
The goal of this clinical trial is to assess the safety and tolerability of colchicine for preventing intracerebral haemorrhage (ICH) recurrence in patients with cerebral amyloid angiopathy (CAA)-ICH at high risk of recurrence. The main questions it aims to answer are: * Is colchicine safe for CAA-ICH patients? * Is co
| Condition(s) | Cerebral Amyloid Angiopathy, Intracerebral Hemorrhage Lobar |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to assess the safety and tolerability of colchicine for preventing intracerebral haemorrhage (ICH) recurrence in patients with cerebral amyloid angiopathy (CAA)-ICH at high risk of recurrence. The main questions it aims to answer are: * Is colchicine safe for CAA-ICH patients? * Is colchicine well tolerated for CAA-ICH patients? Researchers will compare colchicine to a placebo (a look-alike substance that contains no drug) to see if colchicine is safe and tolerable for CAA-ICH patients and works to prevent ICH recurrence. Participants will: * Take colchicine or a placebo every day for 12 months * Receive telephone follow-ups at 3 and 9 months, and visit the clinic at 6 and 12 months for checkups and tests * Control blood pressure and improve lifestyle |
| Who can participate | 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 |
| Ages | 55 Years |
| Sex | All |
| Lead sponsor | Huashan Hospital |
| Locations | Beijing, China; Chengdu, China; Shanghai, China |
| Start date | 2025-06-18 |
| NCT ID | NCT07026994 |
| Official listing | https://clinicaltrials.gov/study/NCT07026994 |