What side effects are associated with this type of intervention?

Common treatments for intracranial hemorrhage, particularly those with anti-inflammatory and anti-fibrotic effects like colchicine, can have several side effects. Colchicine itself is being studied for its safety and efficacy in preventing major cardiovascular events and brain injury post-ICH. General side effects of ICH treatments may include gastrointestinal issues, such as nausea and diarrhea, as well as potential hematologic effects like neutropenia. Additionally, treatments aimed at reducing inflammation and fibrosis may carry risks of infection, liver toxicity, and other systemic effects. It is crucial to monitor patients closely for these adverse events to manage them effectively.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for intracranial hemorrhage that focus on anti-inflammatory and anti-fibrotic effects similar to colchicine. The management of ICH primarily involves supportive care, blood pressure control, and surgical interventions when necessary. Research is ongoing to explore the potential benefits of anti-inflammatory agents like colchicine in preventing secondary brain injury and major cardiovascular events post-ICH, as highlighted by the CoVasc-ICH trial.

What other types of research exist?

Currently, there are no specific novel alternatives to colchicine mentioned for the treatment of intracranial hemorrhage in the provided context. However, ongoing research and pilot trials, such as the CoVasc-ICH trial, aim to establish the safety and efficacy of colchicine for preventing major cardiovascular events and brain injury in ICH patients. For the most up-to-date and personalized treatment options, patients should consult their healthcare provider.

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Anti-inflammatory

Colchicine for Intracranial Hemorrhage (CoVasc-ICH Trial)

Phase 2

Waitlist Available

Led By Aristeidis Katsanos, MD

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with documented spontaneous intraparenchymal hemorrhage within 48 hours of symptom onset (or last seen normal) and qualifying for at least one of the specified categories

Be older than 18 years old

Must not have

Secondary causes of ICH (relating to trauma, macrovascular anomalies, neoplasms or bleeding diathesis)

Cirrhosis or severe hepatic dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up exploratory, from first patient, first visit, until the common study end date (approximately 30 months)

Summary

This trial aims to test if colchicine, an anti-inflammatory medication, can safely prevent heart and brain damage in patients who have had a stroke caused by brain bleeding. Colchicine has been studied for its potential to reduce the incidence of postoperative atrial fibrillation and has shown some effectiveness in reducing inflammation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Colchicine may cause side effects like digestive upset (nausea, diarrhea), blood disorders, muscle pain or weakness. Rarely it might lead to severe allergic reactions. The risk of side effects needs careful monitoring during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have severe liver problems or cirrhosis.

Select...

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

Select...

I have chronic diarrhea or a condition like Crohn's or ulcerative colitis.

Select...

My kidney function is very low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ exploratory, from first patient, first visit, until the common study end date (approximately 30 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~exploratory, from first patient, first visit, until the common study end date (approximately 30 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and exploratory, from first patient, first visit, until the common study end date (approximately 30 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility - Recruitment

Secondary study objectives

Feasibility - Medication Adherence

Feasibility - Refusal Rate

Feasibility - Retention Rate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral Colchicine, 0.5mg once dailyExperimental Treatment1 Intervention

Active colchicine tablet

Group II: Oral matching placebo, once dailyPlacebo Group1 Intervention

Matching placebo tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colchicine Pill

2019

Completed Phase 4

~1240

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Intracranial Hemorrhage (ICH) often focus on reducing inflammation and preventing further damage to brain tissue. Anti-inflammatory agents like colchicine are being studied for their potential to mitigate the inflammatory response that can exacerbate brain injury following an ICH. Colchicine's anti-fibrotic properties may also help in preventing scar tissue formation, which can impair recovery. These mechanisms are crucial as they aim to limit secondary brain damage, improve neurological outcomes, and enhance overall recovery in ICH patients. Effective management of inflammation and fibrosis is essential to reduce complications and improve the quality of life for those affected by ICH.