Can a common Anti-Inflammatory pill protect the heart and brain after a brain bleed?

NCT ID NCT05159219

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

intracerebral hemorrhage Intracranial Hemorrhages

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hamilton General Hospital, Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2, Canada

  • Kingston General Hospital, Kingston Health Sciences

    Kingston, Ontario, Canada

  • London Health Science Centre, University Hospital

    London, Ontario, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, Canada

  • Sunnybrook Hospital

    Toronto, Ontario, Canada

  • Toronto Western Hospital

    Toronto, Ontario, Canada

  • University of Alberta

    Edmonton, Alberta, Canada

  • University of British Columbia

    Vancouver, British Columbia, Canada

  • University of Calgary, Foothills Medical Centre

    Calgary, Alberta, Canada

  • University of Montreal

    Montreal, Quebec, Canada

  • University of Saskatchewan

    Saskatoon, Saskatchewan, Canada

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