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

NCT ID: NCT07026994

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2027-12-31

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.

Conditions

Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage Lobar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Colchicine group

Patients in this arm will receiver oral colchicine 0.5mg once per day for 1 year combined with standard treatment

Group Type: EXPERIMENTAL

Colchicine 0.5mg

Intervention Type: DRUG

Oral colchicine 0.5mg once per day combined with standard treatment

Placebo group

Patients in this arm will receiver oral matching placebo once per day for 1 year combined with standard treatment

Group Type: PLACEBO_COMPARATOR

Matching placebo

Intervention Type: DRUG

Oral matching placebo once per day combined with standard treatment

Interventions

Colchicine 0.5mg

Oral colchicine 0.5mg once per day combined with standard treatment

Intervention Type: DRUG

Matching placebo

Oral matching placebo once per day combined with standard treatment

Intervention Type: DRUG

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xin Cheng

Professor and Vice Chair, Department of Neurology, Huashan Hospital, Fudan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Site Status: NOT_YET_RECRUITING

West China Hospital, Sichuan University

Chengdu, , China

Site Status: NOT_YET_RECRUITING

Huashan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Cheng, MD, PhD

Role: CONTACT

chengxin@fudan.edu.cn

+86 021-52887145

Facility Contacts

Jun Ni, MD, PhD

Role: primary

pumchnijun@163.com

Bo Wu, MD, PhD

Role: primary

drwubo@wchscu.cn

Xin Cheng, MD, PhD

Role: primary

chengxin@fudan.edu.cn

+86 021-52887145

Other Identifiers

KY2025-728

Identifier Type: -

Identifier Source: org_study_id