Clinical trial NCT07026994: Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage
Official title: Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage (CARE-ICH)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cerebral Amyloid Angiopathy
Intracerebral Hemorrhage Lobar
Keywords: Cerebral Amyloid Angiopathy
Intracerebral Hemorrhage
Colchicine
Recurrence
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: West China Hospital
First posted: 2025-06-18
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, placebo-controlled, phase II pilot study
Primary purpose: PREVENTION

Brief 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

Detailed description: 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.

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.

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAE)
timeFrame: Any time within 1 year
measure: Frequency of participants who are adherence to medicine without permanent discontinuation due to TEAE until the end of follow-up.
timeFrame: 1 year
Secondary outcomes:
measure: Safety-Treatment-related adverse events (TRAE)
timeFrame: Any time within 1 year
measure: Safety-TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3
timeFrame: Any time within 1 year
measure: Feasibility-Recruitment rate
timeFrame: 1 year
measure: Feasibility-Retention rate
timeFrame: 1 year
measure: Clinical efficacy-Recurrent symptomatic spontaneous lobar ICH
timeFrame: Any time within 1 year
measure: Clinical efficacy-Composite of major adverse cardiovascular events (MACE)
timeFrame: Any time within 1 year
measure: Clinical efficacy-Any individual MACE
timeFrame: Any time within 1 year
measure: Clinical efficacy-Cognitive outcome
timeFrame: 1 year
measure: Clinical efficacy-Functional outcome
timeFrame: 3-month, 6-month and 1-year
measure: Clinical efficacy-Quality of life
timeFrame: 1 year
measure: Clinical efficacy-Blood inflammatory markers
timeFrame: 6 month and 1 year
measure: Radiological efficacy-New asymptomatic ICH lesion
timeFrame: 1 year
measure: Radiological efficacy-Severe cSS progression
timeFrame: 1 year
measure: Radiological efficacy-Any cSS progression
timeFrame: 1 year
measure: Radiological efficacy-CMB progression
timeFrame: 1 year
Other outcomes:
measure: Exploratory outcomes-Blood-brain barrier permeability
timeFrame: 1 year
measure: Exploratory outcomes-Glymphatic function
timeFrame: 1 year
measure: Exploratory outcomes-Neuroinflammation pattern
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
Study officials:
References: