The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
NCT ID: NCT06763055
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2000 participants
INTERVENTIONAL
2025-02-27
2028-01-31
Brief Summary
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Adaptive interim analyses will be used, with statistical triggers to determine if any of the interventions are superior to control. The end of the trial is defined as the date that all participants have completed their 6-month assessment.
A large amount of preclinical data indicates that the outcome from ICH is linked to the detrimental effects of breakdown substances from brain bleeds. However, there remains a lack of compelling evidence supporting the effectiveness of any pharmacological intervention that can mitigate the secondary cerebral injury. The INTERACT domain aims to assess the effectiveness of intravenous deferoxamine and low-dose oral colchicine, both individually and in combination, to standard of care alone, on improving functional outcome in patients with spontaneous supratentorial ICH.
Those patients who meet eligibility criteria will be randomized to receive one of four interventions:
1. No deferoxamine mesylate and no colchicine (labeled as control)
2. Deferoxamine mesylate only: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days.
3. Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days.
4. Both deferoxamine mesylate and colchicine: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days.
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Detailed Description
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Despite advancements in acute stroke care, there are few effective treatments specifically targeting the brain damage caused by ICH. Previous research has identified that the formation of perihaematomal oedema (PHE) is a critical factor in poor recovery, making it a key focus for therapeutic development.
INTERACT5 domain will focus on two promising medications. Deferoxamine, an iron-chelating agent, targets oxidative stress caused by iron released from damaged brain tissue. Studies suggest it may reduce brain swelling and secondary injury after ICH. Colchicine, an anti-inflammatory medication, inhibits pathways involved in inflammation, which may help minimize brain damage. INTERACT5 will enroll patients aged 18-80 with acute spontaneous supratentorial ICH, confirmed through imaging, who present to the hospital within 24 hours of symptom onset. Other domain-specific inclusion criteria:
* Hematoma volume ≥≥10 mL or any volume post-surgery
* NIHSS score \>8
* GCS ≥8\>7
Participants will be randomized to one of four groups: standard care, deferoxamine alone, colchicine alone, or both treatments combined. Deferoxamine will be administered intravenously (32 mg/kg/day within 1 hour and continued for 2 consecutive days), and colchicine will be given orally (0.5 mg daily for 30 days).
The study's primary outcome is the improvements in functional outcomes at 6 months, measured by the modified Rankin Scale (mRS). Secondary outcomes include EQ-5D-5L at 6 months, changes in PHE size, NIHSS scores, length of hospital stay, ambulatory status at discharge and safety indicators such as mortality at 6 months/SAEs to 6 month, kidney and liver function.
Response Adaptive Randomization (RAR) will be used in this domain to allow readjustment of recruitment towards treatment arms with more favorable emerging effects. Randomization will use minimization method to minimize the imbalance between the number of patients in each treatment group over a number of factors including region, location (deep vs cortical)age (\>65 vs ≤65 years old), sex (male vs female), time from onset (\>6 vs ≤6 hours), haematoma volume (10-29 vs ≥30 mL), receipt of any decompressive surgery (yes vs no), and intraventricular extension of ICH, etc.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
The four arms including three interventions and one control in the domain are the 2x2 factorial of each treatment/no treatment. The one control arm and three intervention arms in the domain are:
1. No DX and No OC (labeled as Control)
2. Yes DX and No OC
3. No DX and Yes OC
4. Yes DX and Yes OC
TREATMENT
SINGLE
The trial will have blinded endpoint assessment on Day 90, with central blinded assessors contacting the participants.
Study Groups
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No deferoxamine mesylate, No colchicine (control)
The group will not receive deferoxamine mesylate or colchicine
Control (Standard treatment)
The group will not receive deferoxamine mesylate or colchicine
Deferoxamine mesylate only
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) of randomization and continued for 2 consecutive days.
Deferoxamine Mesylate
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days
Colchicine only
The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Colchicine 0.5 mg
The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Both deferoxamine mesylate and colchicine
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days; plus 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Colchicine 0.5 mg
The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Deferoxamine Mesylate
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days
Interventions
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Colchicine 0.5 mg
The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Deferoxamine Mesylate
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days
Control (Standard treatment)
The group will not receive deferoxamine mesylate or colchicine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging
3. Presentation to hospital within 24 hours of symptom onset (or last seen well)
4. Hematoma volume ≥10 mL or any volume post-surgery
5. NIHSS score \>8
6. GCS ≥8
7. Provide written informed consent by patient (or approved surrogate)
Exclusion Criteria
2. Isolate intraventricular haemorrhage
3. Chronic Kidney Disease
4. Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up
5. Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability)
6. Women who are pregnant or lactating
7. Previous chelation therapy or known hypersensitivity to deferoxamine products;
8. Severe iron deficiency anaemia (haemoglobin \<7 g/dL or requiring regular blood transfusions);
9. Taking iron supplements containing \>325 mg of ferrous iron;
10. Serum creatinine \>2 mg/dL;
11. Patients with known heart failure taking \>500 mg of vitamin C
12. Allergic to colchicine
13. Myelodysplastic hypoplasia, or liver or severe renal failure
14. Use of medication which may interact with colchicine (e.g., strong CYPsA4 inhibitors such as ketoconazole, strong P-glycoprotein inhibitors such as fluconazole)
18 Years
80 Years
ALL
No
Sponsors
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University of Calgary
OTHER
The George Institute
OTHER
Responsible Party
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Locations
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Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ACT-GLOBAL_ICH_01
Identifier Type: -
Identifier Source: org_study_id
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