Actively Recruiting
Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy Related Intracerebral Hemorrhage (CARE-ICH)
Led by Huashan Hospital · Updated on 2025-06-26
80
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of colchicine for preventing recurrence of intracerebral hemorrhage (ICH) in patients with cerebral amyloid angiopathy (CAA) who are at high risk of another ICH. This phase II randomized, double-blind, placebo-controlled trial aims to compare colchicine to a placebo to see if it is safe, well tolerated, and potentially effective in reducing ICH recurrence. Participants will be randomly assigned to take either oral colchicine 0.5 mg once daily or a matching placebo for one year, alongside standard care including blood pressure control and lifestyle changes. Follow-up visits will occur at 3, 6, 9, and 12 months, during which adverse events, medication adherence, and clinical outcomes will be assessed. During the study, participants will have telephone follow-ups at 3 and 9 months, and clinic visits at 6 and 12 months for checkups and tests including brain MRI scans. Researchers will monitor treatment-emergent adverse events, treatment tolerability, clinical efficacy outcomes like ICH recurrence, cognitive and functional outcomes, quality of life, and blood inflammatory markers. The total participation duration is one year.
CONDITIONS
Brief Title
Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older
- Diagnosed with probable cerebral amyloid angiopathy (CAA) according to modified Boston criteria version 1.5
- High risk of recurrent intracerebral hemorrhage (ICH), defined as 1 prior symptomatic ICH with cortical superficial siderosis or 2 or more prior symptomatic ICHs
- Most recent ICH occurred within the last 3 months
- Modified Rankin Scale score of 4 or less at randomization
- Provided written informed consent before enrollment
You will not qualify if you...
- Secondary causes of intracerebral hemorrhage
- Moderate-to-severe kidney, liver, or blood disorders (such as anemia, low platelet count, low white blood cell count, cirrhosis, or severe kidney insufficiency)
- Prior diagnosis of gout, peripheral neuropathy, myopathy, inflammatory bowel disease, or chronic diarrhea
- Current treatment with immune-suppressants or certain strong medications affecting drug metabolism
- Known allergy or sensitivity to colchicine
- Unable to complete brain MRI or susceptibility weighted imaging scans
- Pregnancy or breastfeeding
- Participation in another interventional study within the past 30 days
- Not expected to survive the follow-up period
- Unable to follow study procedures
- Any condition that the investigators believe may make participation harmful
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive oral colchicine 0.5 mg once per day or matching placebo combined with standard care, including blood pressure control and lifestyle modifications, to prevent recurrence of intracerebral hemorrhage.
Visits at 3, 6, 9, and 12 months for assessments
Trial Site Locations
Total: 3 locations
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Not Yet Recruiting
2
West China Hospital, Sichuan University
Chengdu, China
Not Yet Recruiting
3
Huashan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
X
Xin Cheng, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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