Colchicine for Intracranial Hemorrhage

(CoVasc-ICH Trial)

No longer recruiting at 12 trial locations

Overseen By Kevin W Reeh, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Population Health Research Institute

Must not be taking: CYP3A4 inhibitors, P-gp inhibitors

Disqualifiers: Inflammatory bowel disease, Cirrhosis, Renal insufficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests colchicine, a medication, to determine if it can safely prevent major heart and brain problems in individuals who have experienced a specific type of brain bleed known as intracerebral hemorrhage (ICH). Researchers aim to discover if colchicine can help prevent further vascular issues after such a bleed. Suitable participants include those who have had an ICH within the last two days and have a history of severe artery disease or risk factors like high blood pressure or diabetes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications if they are strong CYP3A4 or P-gp inhibitors, as these are not allowed during the trial. If you're on any of these medications, discuss with the trial team to see if adjustments are needed.

Is there any evidence suggesting that colchicine is likely to be safe for humans?

Research has shown that colchicine, a drug commonly used to treat gout, has been tested in people with a history of stroke or heart issues. In studies involving nearly 15,000 participants, researchers examined colchicine for its ability to prevent further strokes or heart problems. These studies generally found colchicine safe for these patients.

Other research indicates that colchicine, especially in low doses, is unlikely to increase bleeding in people already at risk for brain or other bleeding. This finding is important for those who have had a hemorrhagic stroke, which involves bleeding in the brain.

In this trial, researchers are considering colchicine to see if it can help people after a brain bleed. Evidence from other studies suggests it is usually well-tolerated, meaning most people can manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ICH?

Unlike the standard treatments for intracranial hemorrhage, which typically focus on managing symptoms and preventing further bleeding, colchicine targets inflammation at a cellular level. Researchers are excited about colchicine because it uses a new mechanism of action that could address the underlying inflammatory response associated with brain bleeds. This approach offers the potential for reducing brain damage and improving recovery outcomes, which is a significant shift from current options that mainly offer supportive care.

What evidence suggests that colchicine might be an effective treatment for intracranial hemorrhage?

Research suggests that colchicine, which participants in this trial may receive, could help individuals who have experienced a hemorrhagic stroke by reducing inflammation. Studies have shown that colchicine is safe and does not worsen bleeding after an intracerebral hemorrhage (ICH), a type of stroke that occurs when blood vessels burst in the brain. While unlikely, colchicine might also help prevent further damage after the initial bleeding. More research is needed to confirm these benefits, but early results appear promising. ^{3 4 6 7 8}

Who Is on the Research Team?

Aristeidis Katsanos, MD

Principal Investigator

Population Health Research Institute

Ashkan Shoamanesh, MD

Principal Investigator

Population Health Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals who've had a spontaneous brain bleed within the last 48 hours and can consent to participate. It's not for those with ICH due to trauma, liver issues, or on certain drugs that interact badly with colchicine. Pregnant women and people unlikely to follow the study plan or live less than six months are also excluded.

Inclusion Criteria

I can sign the consent form myself or have someone legally allowed to do it for me.

I had a stroke caused by bleeding in the brain within the last 2 days.

Exclusion Criteria

My brain bleed is not due to injury, abnormal blood vessels, tumors, or bleeding disorders.

I have severe liver problems or cirrhosis.

I am not taking strong CYP3A4 or P-gp inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral colchicine 0.5mg or placebo once daily

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Colchicine

Trial Overview The CoVasc-ICH trial tests if colchicine can prevent heart problems and further brain injury after a brain hemorrhage. Participants will either receive colchicine pills or a placebo, without knowing which one they're getting, to compare outcomes effectively.

How Is the Trial Designed?

Group I: Oral Colchicine, 0.5mg once daily Experimental Treatment 1 Intervention

Active colchicine tablet

Group II: Oral matching placebo, once daily Placebo Group 1 Intervention

Matching placebo tablet

Colchicine is already approved in United States for the following indications:

Approved in United States as Colcrys for:

• Gout
• Familial Mediterranean Fever

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10973719/

A systematic review on the use of Colchicine ... The findings of the research suggest that colchicine can be beneficial for patients with hemorrhagic stroke by reducing inflammation and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36256671/

Colchicine pre-treatment and post-treatment does not ... Our findings suggest that colchicine treatment is safe, unlikely to worsen bleeding, and is unlikely but may reduce secondary injury after an ICH if initiated ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05159219

NCT05159219 | Colchicine for the Prevention of Vascular ... Colchicine pre-treatment and post-treatment does not worsen bleeding or functional outcome after collagenase-induced intracerebral hemorrhage. PLoS One ...

4. nature.com nature.com/articles/s41598-022-13133-0

Effects of colchicine use on ischemic and hemorrhagic ... This study aimed to determine the effect of colchicine use on the risk of stroke among patients with diabetes mellitus (DM).

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0276405

Colchicine pre-treatment and post-treatment does not worsen ... Our findings suggest that colchicine treatment is safe, unlikely to worsen bleeding, and is unlikely but may reduce secondary injury after an ICH if initiated ...

6. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00414-0/fulltext

Colchicine for secondary prevention of ischaemic stroke ... Pooled study-level data from six trials involving 14,934 participants demonstrate that colchicine in patients with prior stroke or coronary ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/215727Orig1s000MedR.pdf

215727Orig1s000 CLINICAL/STATISTICAL REVIEW(S) ... safety data from the LoDoCo and LoDoCo 2 studies that inform the Warning and Precaution Session, drug-drug interactions,. Container Labels & Carton Labeling ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06587737

Study Details | NCT06587737 | Colchicine for the ... Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently ...