ColchicinePhase 3CoVasc-ICH2NCT06587737
Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage
A Phase 3 study testing Colchicine 0.5 MG in people with Colchicine and ICH - Intracerebral Hemorrhage, run by Population Health Research Institute.
Trial summary
Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colchicine, ICH - Intracerebral Hemorrhage, Stroke
- What is being tested?
- Colchicine 0.5 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,125 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Oct 2028
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories:
- history of symptomatic coronary, peripheral and/or carotid artery disease (severe atherosclerotic vascular disease), or ii. visualized extracranial cervical/intracranial atherosclerotic disease causing any degree of stenosis/occlusion or presence of aortic arch plaque with maximum thickness ≥1 mm (moderate atherosclerotic vascular disease), or iii. two or more risk factors including: age 60 years or older, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease (eGFR: 15-50mL/min), history of ischemic stroke or current smoking (mild atherosclerotic vascular disease).
Who cannot join
- secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
- ICH volume more than 60ml in the last imaging scan prior to consent
- Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent
- inflammatory bowel disease or chronic diarrhea
- cirrhosis or severe hepatic dysfunction
- renal insufficiency (eGFR<15mL/min)
Show all 12Show fewer
- concurrent or planned treatment with strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-gp inhibitors (cyclosporine, ranolazine)
- pregnancy or breast-feeding
- known allergy or sensitivity to colchicine
- a strong indication for colchicine where assignment to placebo is deemed unacceptable
- estimated life expectancy less than 6 months at the time of enrollment, and
- inability to adhere to study procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amanda Taylor, BSc contact
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Phase III Study for Reducing Dependency and Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous Intracerebral Hemorrhage and Established, or Risk Factors for, Atherosclerosis
Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors.
The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.
- Conditions
- Colchicine, ICH - Intracerebral Hemorrhage, Stroke, Dependence
- Being tested
- Colchicine 0.5 MG, Placebo
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
colchicine 0.5mg once-daily
PlaceboDrug
matching placebo, lacking active ingredient, once-daily
| Study group | Role | What they receive |
|---|---|---|
| colchicine 0.5mg OD | Experimental | Not described Receives: Drug: Colchicine 0.5 MG |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: MACE and Dependency
Treatment with colchicine will reduce the risk for major adverse cardiovascular events (MACE) and dependency
Measured: through study completion, an average of 36 months
Safety: Symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates
There will be no clinically-important change in symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates with oral colchicine 0.5mg OD compared with matching placebo
Measured: through study completion, an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColchicineStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled, phase III study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aristeidis Katsanos, MD, Principal investigator, Population Health Research Institute, Hamilton Health Sciences, McMaster UniversityAshkan Shoamanesh, MD, Principal investigator, Population Health Research Institute, Hamilton Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587737
- Sponsor's protocol ID
- CoVasc-ICH2
- Acronym
- CoVasc-ICH2
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Phase III Study for Reducing Dependency and Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous Intracerebral Hemorrhage and Established, or Risk Factors for, Atherosclerosis
- ClinicalTrials.gov ID
- NCT06587737
- Acronym / sponsor ID
- CoVasc-ICH2 / CoVasc-ICH2
- Conditions
- Colchicine, ICH - Intracerebral Hemorrhage, Stroke, Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,125 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors.
The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.
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 III study
| Arm | Type | Receives |
|---|---|---|
| colchicine 0.5mg OD | Experimental | Drug: Colchicine 0.5 MG |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories:
- history of symptomatic coronary, peripheral and/or carotid artery disease (severe atherosclerotic vascular disease), or ii. visualized extracranial cervical/intracranial atherosclerotic disease causing any degree of stenosis/occlusion or presence of aortic arch plaque with maximum thickness ≥1 mm (moderate atherosclerotic vascular disease), or iii. two or more risk factors including: age 60 years or older, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease (eGFR: 15-50mL/min), history of ischemic stroke or current smoking (mild atherosclerotic vascular disease).
Key exclusion criteria (12 listed)
- secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
- ICH volume more than 60ml in the last imaging scan prior to consent
- Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent
- inflammatory bowel disease or chronic diarrhea
- cirrhosis or severe hepatic dysfunction
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 0.5 MGcolchicine 0.5mg once-daily | Drug | colchicine 0.5mg OD |
| Placebomatching placebo, lacking active ingredient, once-daily | Drug | placebo |
Primary outcome
Efficacy: MACE and Dependency
Time frame: through study completion, an average of 36 months
Treatment with colchicine will reduce the risk for major adverse cardiovascular events (MACE) and dependency
Safety: Symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates
Time frame: through study completion, an average of 36 months
There will be no clinically-important change in symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates with oral colchicine 0.5mg OD compared with matching placebo
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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Amanda Taylor, BSc contact
Aristeidis Katsanos, MD principal investigator
Population Health Research Institute, Hamilton Health Sciences, McMaster University
Ashkan Shoamanesh, MD principal investigator
Population Health Research Institute, Hamilton Health Sciences, McMaster University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 MG in people with Colchicine and ICH - Intracerebral Hemorrhage, run by Population Health Research Institute.
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 2 inclusion and 12 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Kevin W Reeh, MSc (905-521-2100, CoVasc-ICH2@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: MACE and Dependency (time frame: through study completion, an average of 36 months). 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 1 Sep 2026.