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
The CARE-ICH study is a multicenter, randomized, double-blind, placebo-controlled, phase II trial. The primary objective of the CARE-ICH study is to assess the safety and tolerability of colchicine for preventing ICH recurrence in patients with CAA-ICH at high risk of recurrence, as well as provide a preliminary estimate of the feasibility and efficacy for planning a phase III trial. Patients with CAA-ICH and a high risk of recurrence-defined as 1 prior symptomatic ICH and presence of cortical superficial siderosis, or ≥2 prior symptomatic ICHs-within 3 months of their most recent ICH will be enrolled and randomized in a 1:1 ratio to receive either oral colchicine 0.5 mg once per day or matching placebo for 1 year, in addition to standard care, including blood pressure control and lifestyle modifications. Follow-up visits will take place at 3, 6, 9, and 12 months. Each visit will include assessments of adverse events, medication adherence, and clinical outcomes. The primary outcomes are the incidence of treatment-emergent adverse events and treatment tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
Oral colchicine 0.5mg once per day combined with standard treatment
Oral matching placebo once per day combined with standard treatment
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
NOT_YET_RECRUITINGWest China Hospital, Sichuan University
Chengdu, China
NOT_YET_RECRUITINGHuashan Hospital, Fudan University
Shanghai, China
RECRUITINGIncidence of treatment emergent adverse events (TEAE)
Incidence of treatment emergent adverse events (TEAE)
Time frame: Any time within 1 year
Frequency of participants who are adherence to medicine without permanent discontinuation due to TEAE until the end of follow-up.
Frequency of participants who are adherence to medicine without permanent discontinuation due to TEAE until the end of follow-up
Time frame: 1 year
Safety-Treatment-related adverse events (TRAE)
An AE assessed as having a causal relationship to the study product, and be classified as definitely, probably or possibly related AEs
Time frame: Any time within 1 year
Safety-TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3
TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3
Time frame: Any time within 1 year
Feasibility-Recruitment rate
The mean number of participants randomized per site per year
Time frame: 1 year
Feasibility-Retention rate
Randomized participants who completed 1-year follow-up
Time frame: 1 year
Clinical efficacy-Recurrent symptomatic spontaneous lobar ICH
A new non-traumatic lobar ICH lesion confirmed on SWI or CT with corresponding symptoms
Time frame: Any time within 1 year
Clinical efficacy-Composite of major adverse cardiovascular events (MACE)
Stroke (ischemic, hemorrhagic or undefined), myocardial infarction, revascularization procedure for coronary, carotid or peripheral arterial disease, and vascular death
Time frame: Any time within 1 year
Clinical efficacy-Any individual MACE
Stroke (ischemic, hemorrhagic or undefined), myocardial infarction, revascularization procedure for coronary, carotid or peripheral arterial disease, and vascular death
Time frame: Any time within 1 year
Clinical efficacy-Cognitive outcome
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) (The total score ranges from 0 to 30, with higher scores indicating better cognitive function)
Time frame: 1 year
Clinical efficacy-Functional outcome
Functional outcome assessed by the modified Rankin scale (mRS) \[mRS score ranges from 0 (no symptom) to 6 (death) and higher score means worse functional outcome\]
Time frame: 3-month, 6-month and 1-year
Clinical efficacy-Quality of life
Quality of life assessed by the EuroQol Five-Dimension Five-Level (EQ-5D-5L) questionnaire, which consists of two parts. The descriptive system evaluates health across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels of severity, where higher levels indicate more severe problems. The visual analogue scale is rated from 0 (worst imaginable health state) to 100 (best imaginable health state), representing the patient's self-rated overall health.
Time frame: 1 year
Clinical efficacy-Blood inflammatory markers
High-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6).
Time frame: 6 month and 1 year
Radiological efficacy-New asymptomatic ICH lesion
A new hemorrhagic lesion confirmed on SWI at 1-year, which was absent on SWI at baseline and was not associated with any acute neurological deficit
Time frame: 1 year
Radiological efficacy-Severe cSS progression
≥2 new cSS foci on 1-year SWI scan
Time frame: 1 year
Radiological efficacy-Any cSS progression
≥1 new cSS foci on 1-year SWI scan
Time frame: 1 year
Radiological efficacy-CMB progression
≥5 new CMBs on 1-year SWI scan
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.