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Recruiting NCT07026994

Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage

Phase II Interventional Cerebral Amyloid Angiopathy Intracerebral Hemorrhage Lobar

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colchicine 0.5mg, Matching placebo.
Who it may be relevant to
Registry conditions: Cerebral Amyloid Angiopathy, Intracerebral Hemorrhage Lobar. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Colchicine 0.5mg
    Oral colchicine 0.5mg once per day combined with standard treatment
  • Drug Matching placebo
    Oral matching placebo once per day combined with standard treatment

Primary outcome measures

  • 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. [Time frame: 1 year]
Secondary outcome measures (12)
  • Safety-Treatment-related adverse events (TRAE) [Time frame: Any time within 1 year]
  • Safety-TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 [Time frame: Any time within 1 year]
  • Feasibility-Recruitment rate [Time frame: 1 year]
  • Feasibility-Retention rate [Time frame: 1 year]
  • Clinical efficacy-Recurrent symptomatic spontaneous lobar ICH [Time frame: Any time within 1 year]
  • Clinical efficacy-Composite of major adverse cardiovascular events (MACE) [Time frame: Any time within 1 year]
  • Clinical efficacy-Any individual MACE [Time frame: Any time within 1 year]
  • Clinical efficacy-Cognitive outcome [Time frame: 1 year]
  • Clinical efficacy-Functional outcome [Time frame: 3-month, 6-month and 1-year]
  • Clinical efficacy-Quality of life [Time frame: 1 year]
  • Clinical efficacy-Blood inflammatory markers [Time frame: 6 month and 1 year]
  • Radiological efficacy-New asymptomatic ICH lesion [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 3 centers
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Unio — Beijing
  • West China Hospital, Sichuan University — Chengdu
  • Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07026994 · KY2025-728

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗