NCT07026994 Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage
| NCT ID | NCT07026994 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Huashan Hospital |
| Condition | Cerebral Amyloid Angiopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-06-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07026994 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Cerebral Amyloid Angiopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07026994 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07026994 currently recruiting?
Yes, NCT07026994 is actively recruiting participants. Contact the research team at chengxin@fudan.edu.cn for enrollment information.
Where is the NCT07026994 trial being conducted?
This trial is being conducted at Beijing, China, Chengdu, China, Shanghai, China.
Who is sponsoring the NCT07026994 clinical trial?
NCT07026994 is sponsored by Huashan Hospital. The trial plans to enroll 80 participants.