Cerebral Amyloid AngiopathyPhase 2CARE-ICHNCT07026994
Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage
A Phase 2 study testing Colchicine 0.5mg in people with Cerebral Amyloid Angiopathy and Intracerebral Hemorrhage Lobar, run by Huashan Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy, Intracerebral Hemorrhage Lobar
- What is being tested?
- Colchicine 0.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesChina
- Study dates
- 18 Jun 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Jun Ni, MD, PhD, pumchnijun@163.com
Jun Ni, MD, PhD
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu
Bo Wu, MD, PhD, drwubo@wchscu.cn
Bo Wu, MD, PhD
- Recruiting
Huashan Hospital, Fudan University
Shanghai
Xin Cheng, MD, PhD, +86 021-52887145, chengxin@fudan.edu.cn
Xin Cheng, MD, PhD
About this study
Official title: Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage (CARE-ICH)
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:
Read more
- 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
Read the 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.
- Being tested
- Colchicine 0.5mg, Matching placebo
- Keywords
- Cerebral Amyloid Angiopathy, Intracerebral Hemorrhage, Colchicine, Recurrence
- Medical subject headings
- Cerebral Amyloid Angiopathy, Cerebral Hemorrhage, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5mgDrug
Oral colchicine 0.5mg once per day combined with standard treatment
Matching placeboDrug
Oral matching placebo once per day combined with standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Colchicine group | Experimental | Patients in this arm will receiver oral colchicine 0.5mg once per day for 1 year combined with standard treatment Receives: 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 Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAE)
Incidence of treatment emergent adverse events (TEAE)
Measured: 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
Measured: 1 year
Secondary outcomes (15)
Safety-Treatment-related adverse events (TRAE)
An AE assessed as having a causal relationship to the study product, and be classified as definitely, probably or possibly related AEs
Measured: Any time within 1 year
Safety-TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3
TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3
Measured: Any time within 1 year
Feasibility-Recruitment rate
The mean number of participants randomized per site per year
Measured: 1 year
Feasibility-Retention rate
Randomized participants who completed 1-year follow-up
Measured: 1 year
Clinical efficacy-Recurrent symptomatic spontaneous lobar ICH
A new non-traumatic lobar ICH lesion confirmed on SWI or CT with corresponding symptoms
Measured: Any time within 1 year
Clinical efficacy-Composite of major adverse cardiovascular events (MACE)
Stroke (ischemic, hemorrhagic or undefined), myocardial infarction, revascularization procedure for coronary, carotid or peripheral arterial disease, and vascular death
Measured: Any time within 1 year
Clinical efficacy-Any individual MACE
Stroke (ischemic, hemorrhagic or undefined), myocardial infarction, revascularization procedure for coronary, carotid or peripheral arterial disease, and vascular death
Measured: Any time within 1 year
Clinical efficacy-Cognitive outcome
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA) (The total score ranges from 0 to 30, with higher scores indicating better cognitive function)
Measured: 1 year
Clinical efficacy-Functional outcome
Functional outcome assessed by the modified Rankin scale (mRS) [mRS score ranges from 0 (no symptom) to 6 (death) and higher score means worse functional outcome]
Measured: 3-month, 6-month and 1-year
Clinical efficacy-Quality of life
Quality of life assessed by the EuroQol Five-Dimension Five-Level (EQ-5D-5L) questionnaire, which consists of two parts. The descriptive system evaluates health across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels of severity, where higher levels indicate more severe problems. The visual analogue scale is rated from 0 (worst imaginable health state) to 100 (best imaginable health state), representing the patient's self-rated overall health.
Measured: 1 year
Clinical efficacy-Blood inflammatory markers
High-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6).
Measured: 6 month and 1 year
Radiological efficacy-New asymptomatic ICH lesion
A new hemorrhagic lesion confirmed on SWI at 1-year, which was absent on SWI at baseline and was not associated with any acute neurological deficit
Measured: 1 year
Radiological efficacy-Severe cSS progression
≥2 new cSS foci on 1-year SWI scan
Measured: 1 year
Radiological efficacy-Any cSS progression
≥1 new cSS foci on 1-year SWI scan
Measured: 1 year
Radiological efficacy-CMB progression
≥5 new CMBs on 1-year SWI scan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start18 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled, phase II pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, West China Hospital
- Responsible party
- Principal investigator, Xin Cheng, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026994
- Sponsor's protocol ID
- KY2025-728
- Acronym
- CARE-ICH
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for the study can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage (CARE-ICH)
- ClinicalTrials.gov ID
- NCT07026994
- Acronym / sponsor ID
- CARE-ICH / KY2025-728
- Keywords
- Cerebral Amyloid Angiopathy, Intracerebral Hemorrhage, Colchicine, Recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, West China Hospital
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled, phase II pilot study
| Arm | Type | Receives |
|---|---|---|
| Colchicine group | Experimental | Drug: Colchicine 0.5mgPatients in this arm will receiver oral colchicine 0.5mg once per day for 1 year combined with standard treatment |
| Placebo group | Placebo comparator | Drug: Matching placeboPatients in this arm will receiver oral matching placebo once per day for 1 year combined with standard treatment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5mgOral colchicine 0.5mg once per day combined with standard treatment | Drug | Colchicine group |
| Matching placeboOral matching placebo once per day combined with standard treatment | Drug | Placebo group |
Primary outcome
Incidence of treatment emergent adverse events (TEAE)
Time frame: Any time within 1 year
Incidence of treatment emergent adverse events (TEAE)
Frequency of participants who are adherence to medicine without permanent discontinuation due to TEAE until the end of follow-up.
Time frame: 1 year
Frequency of participants who are adherence to medicine without permanent discontinuation due to TEAE until the end of follow-up
15 secondary outcomes
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
Radiological efficacy-Severe cSS progression
Time frame: 1 year
Radiological efficacy-Any cSS progression
Time frame: 1 year
Radiological efficacy-CMB progression
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Yes. Data collected for the study can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine 0.5mg in people with Cerebral Amyloid Angiopathy and Intracerebral Hemorrhage Lobar, run by Huashan Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Cheng, MD, PhD (+86 021-52887145, chengxin@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAE) (time frame: Any time within 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.