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

NCT07026994 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Huashan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026994 on ClinicalTrials.gov