Colchicine to prevent repeat lobar brain bleeds from cerebral amyloid angiopathy

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

This trial will test whether taking a daily low-dose colchicine pill for a year is safe and helps prevent repeat lobar intracerebral hemorrhage in people with cerebral amyloid angiopathy who are at high risk of another bleed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Drugs / interventions: rituximab, cyclophosphamide
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT07026994 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 55 or older with probable CAA who had a recent lobar ICH (within 3 months) and are at high risk of recurrence because of prior ICHs and/or cortical superficial siderosis.

Not a fit: Patients with secondary causes of ICH, severe kidney or liver disease, significant blood disorders, or those outside the recent-ICH window (>3 months) are unlikely to qualify or benefit.

Why it matters

Potential benefit: If colchicine is safe and tolerable, it could offer a simple, low-cost oral option to reduce the risk of recurrent lobar ICH in patients with CAA.

How similar studies have performed: Colchicine has shown benefit in other vascular inflammatory conditions such as post-myocardial infarction, but its use specifically to prevent CAA-related ICH recurrence is novel and unproven.

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.

Where this trial is running

Beijing and 2 other locations

• 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)
• Huashan Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xin Cheng, MD, PhD

Conditions Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage Lobar; Intracerebral Hemorrhage; Colchicine; Recurrence