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

NCT07026994 | Recruiting Phase 2 DMC

• 1 other identifier: KY2025-728
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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

Conditions

Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage Lobar

Keywords

Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage; Colchicine; Recurrence

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent adverse events (TEAE)

  Incidence of treatment emergent adverse events (TEAE)

  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

  1 year

Secondary Outcomes (15)

• Safety-Treatment-related adverse events (TRAE)

  Any time within 1 year

• Safety-TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3

  Any time within 1 year

• Feasibility-Recruitment rate

  1 year

• Feasibility-Retention rate

  1 year

• Clinical efficacy-Recurrent symptomatic spontaneous lobar ICH

  Any time within 1 year

Other Outcomes (3)

• Exploratory outcomes-Blood-brain barrier permeability

  1 year

• Exploratory outcomes-Glymphatic function

  1 year

• Exploratory outcomes-Neuroinflammation pattern

  1 year

Study Arms (2)

Colchicine group

EXPERIMENTAL

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

Drug: Colchicine 0.5mg

Placebo group

PLACEBO COMPARATOR

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

Drug: Matching placebo

Interventions

Colchicine 0.5mg DRUG

Oral colchicine 0.5mg once per day combined with standard treatment

Colchicine group

Matching placebo DRUG

Oral matching placebo once per day combined with standard treatment

Placebo group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Peking Union Medical College Hospital: collaborator
• West China Hospital: collaborator

Study Sites (3)

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

Beijing, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, China

NOT YET RECRUITING

Huashan Hospital, Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy; Cerebral Hemorrhage; Recurrence

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Central Study Contacts

Xin Cheng, MD, PhD

CONTACT

+86 021-52887145; chengxin@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair, Department of Neurology, Huashan Hospital, Fudan University

Model Details: Double-blind, randomized, placebo-controlled, phase II pilot study

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 18, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)