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

ConditionsCerebral Amyloid Angiopathy Intracerebral Hemorrhage Lobar

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age55+

SponsorHuashan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Colchicine groupExperimental treatment 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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 outcomes

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

Time frame

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

Time frame

Any time within 1 year

Feasibility-Recruitment rate

The mean number of participants randomized per site per year

Time frame

1 year

Feasibility-Retention rate

Randomized participants who completed 1-year follow-up

Time frame

1 year

Other outcomes

Exploratory outcomes-Blood-brain barrier permeability

Water exchange rate (kw) measured by diffusion-prepared pseudocontinuous arterial spin labeling (DP-pCASL) imaging

Time frame

1 year

Exploratory outcomes-Glymphatic function

The index for diffusivity along the perivascular space (ALPS index) measured by diffusion tensor imaging

Time frame

1 year

Exploratory outcomes-Neuroinflammation pattern

The standardized uptake value ratio of 18F-DPA-714 measured by translocator protein (TSPO)-PET

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huashan Hospital

Lead sponsor

Peking Union Medical College Hospital

Collaborator

West China Hospital

Collaborator

Source ClinicalTrials.gov

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