Can a common Anti-Inflammatory pill protect the heart and brain after a brain bleed?
NCT ID NCT05159219
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether taking colchicine, an anti-inflammatory drug, once daily can prevent major cardiovascular events like heart attacks and strokes in people who have just had a brain bleed (intracerebral hemorrhage). The study includes about 100 adults who have had a spontaneous brain bleed within the last 48 hours and also have signs of atherosclerosis or risk factors for it. Half will receive colchicine and half a placebo, and the main goal is to see if a larger trial is feasible, while also gathering early data on safety and potential benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine, an anti-inflammatory drug taken as a pill
- What this could lead to
- If colchicine works, it could offer a new way to prevent heart attacks, strokes, and further brain injury in people who have had a brain bleed.
- What could go wrong
- This is a small pilot study focused on feasibility, not proof of benefit. Colchicine may not reduce cardiovascular events, and it can cause side effects like stomach upset.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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100 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Adult participants are eligible to be included in the study only if all of the following criteria apply: Type of Participant and Disease Characteristics 1. Participants with documented spontaneous intraparenchymal hemorrhage within 48 hours of symptom onset (or last seen normal) and 2. Qualifying for at least one of the following categories: i. 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) Informed Consent 3. Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Secondary causes of ICH (relating to trauma, macrovascular anomalies, neoplasms or bleeding diathesis) 2. Inflammatory bowel disease or chronic diarrhea 3. Cirrhosis or severe hepatic dysfunction 4. Renal insufficiency (eGFR \<15mL/min) Prior/Concomitant Therapy 5. Concurrent 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) 6. Known allergy or sensitivity to colchicine 7. Strong indication for colchicine where assignment to placebo is deemed unacceptable Other Exclusions 8. Pregnant or breast-feeding 9. Inability to adhere to study procedures 10. Estimated life expectancy less than 6 months at the time of enrollment 11. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hamilton General Hospital, Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
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Kingston General Hospital, Kingston Health Sciences
Kingston, Ontario, Canada
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London Health Science Centre, University Hospital
London, Ontario, Canada
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Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
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Sunnybrook Hospital
Toronto, Ontario, Canada
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Toronto Western Hospital
Toronto, Ontario, Canada
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University of Alberta
Edmonton, Alberta, Canada
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University of British Columbia
Vancouver, British Columbia, Canada
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University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada
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University of Montreal
Montreal, Quebec, Canada
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University of Saskatchewan
Saskatoon, Saskatchewan, Canada
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Other studies related to the condition(s) this trial covers.
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