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Anti-inflammatory

Colchicine for Intracranial Hemorrhage (CoVasc-ICH Trial)

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up exploratory, from first patient, first visit, until the common study end date (approximately 30 months)
Awards & highlights

CoVasc-ICH Trial Summary

This trial is designed to see if colchicine is safe and effective in preventing major cardiovascular events and brain injury in patients who have had a stroke.

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.Check my eligibility
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.See study design
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.

CoVasc-ICH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stroke caused by bleeding in the brain within the last 2 days.

CoVasc-ICH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility - Recruitment
Secondary outcome measures
Feasibility - Medication Adherence
Feasibility - Refusal Rate
Feasibility - Retention Rate

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981
1%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine
Placebo

CoVasc-ICH 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
~920

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
679,812 Total Patients Enrolled
Aristeidis Katsanos, MDPrincipal InvestigatorPopulation Health Research Institute
Ashkan Shoamanesh, MDPrincipal InvestigatorPopulation Health Research Institute

Media Library

Colchicine (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT05159219 — Phase 2
Intracranial Hemorrhage Research Study Groups: Oral Colchicine, 0.5mg once daily, Oral matching placebo, once daily
Intracranial Hemorrhage Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT05159219 — Phase 2
Colchicine (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159219 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any positions still available in this trial?

"The online clinical trials database reports that this study is still looking for patients to enroll. The listing was first published on August 4th, 2020 and was updated on August 12th of the same year."

Answered by AI

What are the harmful side effects of Colchicine Pill?

"While Phase 2 trials don't have the same level of data to support efficacy, the available evidence on Colchicine Pill's safety is strong enough that we've given it a score of 2."

Answered by AI

For what purpose is Colchicine Pill most often prescribed?

"The Colchicine Pill can ameliorate the symptoms of gout flares, behcet's syndrome, and postcommissurotomy syndrome."

Answered by AI

Are there any similar cases to Colchicine Pill in the medical literature?

"At this time, there are 32 different clinical trials underway for Colchicine Pill. Of these, 13 are in Phase 3. Additionally, these trials for Colchicine Pill are not limited to New york City as there are 189 research sites across the globe."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage
2022. "Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05159219.
~31 spots leftby Feb 2025
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