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RECRUITING

NCT07026994

PHASE2

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

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

Official title: Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage (CARE-ICH)

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-18

Completion Date

2027-12

Last Updated

2025-06-26

Healthy Volunteers

Conditions

Cerebral Amyloid Angiopathy Intracerebral Hemorrhage Lobar

Interventions

DRUG

Colchicine 0.5mg

Oral colchicine 0.5mg once per day combined with standard treatment

DRUG

Matching placebo

Oral matching placebo once per day combined with standard treatment

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.

Locations (3)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

West China Hospital, Sichuan University

Chengdu, China

Huashan Hospital, Fudan University

Shanghai, China