Actively Recruiting
Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage
Led by Huashan Hospital · Updated on 2025-06-26
80
Participants Needed
3
Research Sites
128 weeks
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
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
CONDITIONS
Official 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) using the modified Boston criteria (version 1.5)
- High risk of recurrent intracerebral hemorrhage (ICH), defined as either 1 prior symptomatic ICH with cortical superficial siderosis or 2 or more prior symptomatic ICHs
- Time since most recent ICH symptom onset is 3 months or less (earlier enrollment preferred if criteria met)
- Modified Rankin Scale score of 4 or less at randomization
- Provided written informed consent or consent from legally authorized representative before enrollment
You will not qualify if you...
- Secondary causes of intracerebral hemorrhage (ICH)
- Moderate to severe kidney, liver, or blood disorders (including anemia with hemoglobin less than 10 g/dL, low platelet count, low white blood cell count, liver cirrhosis or severe dysfunction, kidney failure with eGFR less than 15 mL/min)
- Prior diagnosis of gout, peripheral neuropathy, myopathy, inflammatory bowel disease, or chronic diarrhea
- Current use of regular immune-suppressant drugs or moderate to strong CYP3A4 or P-glycoprotein inhibitors
- Known allergy, sensitivity, or intolerance to colchicine
- Unable to complete brain MRI or susceptibility weighted imaging scans
- Pregnant or breastfeeding
- Participation in another interventional study within 30 days before enrollment
- Expected not to survive the follow-up period
- Unable to follow study procedures
- Any condition that investigators believe makes study participation harmful
AI-Screening
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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
CONTACT
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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