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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
NOT_YET_RECRUITING
Beijing
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xin Cheng, MD, PhD
chengxin@fudan.edu.cn
+86 021-52887145
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Treatments
Experimental: Colchicine group
Patients in this arm will receiver oral colchicine 0.5mg once per day for 1 year combined with standard treatment
Placebo_comparator: Placebo group
Patients in this arm will receiver oral matching placebo once per day for 1 year combined with standard treatment
Sponsors
Collaborators: Peking Union Medical College Hospital, West China Hospital
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov