Colchicine to prevent repeat lobar brain bleeds from cerebral amyloid angiopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CARE-ICH is a multicenter, randomized, double-blind, placebo-controlled phase II trial comparing oral colchicine 0.5 mg daily to matching placebo for 12 months in patients with CAA-related lobar ICH at high risk of recurrence. Eligible participants are aged 55 or older with probable CAA and either one prior ICH plus cortical superficial siderosis or two or more prior symptomatic ICHs, enrolled within three months of the most recent bleed. All participants receive standard care including blood pressure control and lifestyle advice, with follow-up visits and telephone checks at 3, 6, 9 and 12 months to record adverse events, adherence, and clinical outcomes. The primary endpoints are the incidence of treatment-emergent adverse events and medication tolerability, with preliminary efficacy and feasibility data collected to inform a possible phase III trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, China Recruiting
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Not yet recruiting
• West China Hospital, Sichuan University
  Chengdu, China Not yet recruiting

Study contacts

• Study coordinator: Xin Cheng, MD, PhD
• Email: chengxin@fudan.edu.cn
• Phone: +86 021-52887145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.