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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intracranial Hemorrhages

Intervention / Treatment
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* Drug: Colchicine Pill
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 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: 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 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 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) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Feasibility, double-blind, placebo-controlled randomized controlled trial (RCT)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Colchicine, 0.5mg once daily<br>Active colchicine tablet | Drug: Colchicine Pill<br>* Anti-inflammatory<br>|
| Placebo Comparator: Oral matching placebo, once daily<br>Matching placebo tablet | Other: Placebo<br>* Inert ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Recruitment | Recruitment Rate, mean of approximately 10 participants per site, per year | From site activation until the end of recruitment (approximately 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Refusal Rate | Refusal to participate is not a substantial barrier to recruitment | Exploratory, from first patient, first visit, until the common study end date (approximately 30 months) | 
| Feasibility - Retention Rate | Retention of ≥90% of study participants | At 6 months from randomization | 
| Feasibility - Medication Adherence | Adherence >75% | At 12 months from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Hemorrhage, Colchicine