AzTrials
AzTrials

Intracranial HemorrhagesPhase 2CoVasc-ICHNCT05159219

Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage

A Phase 2 study testing Colchicine Pill in people with Intracranial Hemorrhages, run by Population Health Research Institute at 11 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overall goal is to establish the safety and efficacy of colchicine in ICH patients for the prevention of major cardiovascular events and brain injury. Colchicine for the prevention of vascular events after an acute intracerebral hemorrhage (CoVasc-ICH) is a vanguard pilot trial designed to obtain the factual… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Hemorrhages
What is being tested?
Colchicine Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
11 sitesCanada
Study dates
4 Aug 2022to 3 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 participants are eligible to be included in the study only if all of the following criteria apply:
  • Type of Participant and Disease Characteristics
  • Participants with documented spontaneous intraparenchymal hemorrhage within 48 hours of symptom onset (or last seen normal) 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)
  • Informed Consent
  • 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.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions
  • Secondary causes of ICH (relating to trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
  • Inflammatory bowel disease or chronic diarrhea
  • Cirrhosis or severe hepatic dysfunction
  • Renal insufficiency (eGFR <15mL/min)
Show all 15Show fewer
  • Prior/Concomitant Therapy
  • 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)
  • Known allergy or sensitivity to colchicine
  • Strong indication for colchicine where assignment to placebo is deemed unacceptable
  • Other Exclusions
  • Pregnant or breast-feeding
  • Inability to adhere to study procedures
  • Estimated life expectancy less than 6 months at the time of enrollment
  • 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)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • University of Calgary, Foothills Medical Centre

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta

  • Hamilton General Hospital, Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • Kingston General Hospital, Kingston Health Sciences

    Kingston, Ontario

  • London Health Science Centre, University Hospital

    London, Ontario

  • University of Montreal

    Montreal, Quebec

  • Ottawa Hospital Research Institute

    Ottawa, Ontario

  • University of Saskatchewan

    Saskatoon, Saskatchewan

  • Sunnybrook Hospital

    Toronto, Ontario

  • Toronto Western Hospital

    Toronto, Ontario

  • University of British Columbia

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: A Vanguard, Double-blind, Randomized, Placebo-controlled, Phase 2 Pilot Study to Investigate Prevention of Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous ICH and Established, or Risk Factors for, Atherosclerosis

The overall goal is to establish the safety and efficacy of colchicine in ICH patients for the prevention of major cardiovascular events and brain injury. Colchicine for the prevention of vascular events after an acute intracerebral hemorrhage (CoVasc-ICH) is a vanguard pilot trial designed to obtain the factual feasibility prerequisites essential for the planning, design, funding and execution of a subsequent phase III trial.

Being tested
Colchicine Pill, Placebo
Keywords
Intracranial Hemorrhage, Colchicine
Medical subject headings
Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colchicine PillDrug

    Anti-inflammatory

  • PlaceboOther

    Inert ingredients

Study groups in NCT05159219
Study groupRoleWhat they receive
Oral Colchicine, 0.5mg once dailyExperimentalActive colchicine tablet
Receives: Drug: Colchicine Pill
Oral matching placebo, once dailyPlacebo comparatorMatching placebo tablet
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Recruitment

    Recruitment Rate, mean of approximately 10 participants per site, per year

    Measured: From site activation until the end of recruitment (approximately 18 months)

Secondary outcomes (3)

  1. Feasibility - Refusal Rate

    Refusal to participate is not a substantial barrier to recruitment

    Measured: Exploratory, from first patient, first visit, until the common study end date (approximately 30 months)

  2. Feasibility - Retention Rate

    Retention of ≥90% of study participants

    Measured: At 6 months from randomization

  3. Feasibility - Medication Adherence

    Adherence >75%

    Measured: At 12 months from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start4 Aug 2022
  3. Primary completion3 Dec 2024
  4. Study completion3 Dec 2024

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility, double-blind, placebo-controlled randomized controlled trial (RCT)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159219
Sponsor's protocol ID
CoVasc-ICH
Acronym
CoVasc-ICH
Status last verified
Jan 2025
First submitted
22 Nov 2021
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Katsanos AH, Ng KKH, Field TS, Ganesh A, Schaafsma JD, Jalini S, Shuaib A, Mai LM, Yu AYX, Gioia LC, Cooley R, Dowlatshahi D, Srivastava A, Tsivgoulis G, Wang A, Balasubramanian K, Reeh KW, Taylor A, Hart RG, Shoamanesh A. Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage: A Placebo-Controlled Trial. Stroke. 2026 Aug 6. doi: 10.1161/STROKEAHA.126.055934. Online ahead of print.

    PubMed 42558067

  • Wilkinson CM, Katsanos AH, Sander NH, Kung TFC, Colbourne F, Shoamanesh A. Colchicine pre-treatment and post-treatment does not worsen bleeding or functional outcome after collagenase-induced intracerebral hemorrhage. PLoS One. 2022 Oct 18;17(10):e0276405. doi: 10.1371/journal.pone.0276405. eCollection 2022.

    PubMed 36256671

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine Pill in people with Intracranial Hemorrhages, run by Population Health Research Institute at 11 sites in Canada.

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 7 inclusion and 15 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: finished, 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.

Where is the study taking place?

The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Recruitment (time frame: From site activation until the end of recruitment (approximately 18 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05159219, which also lists 2 linked publications.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in