CompletedPhase 2

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

Canada100 participantsStarted 2022-08-04

Plain-language 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 feasibility prerequisites essential for the planning, design, funding and execution of a subsequent phase III trial.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. 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

✕. 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)
✕. 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
✕. Pregnant or breast-feeding

What they're measuring

Feasibility - Recruitment

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

Trial details

NCT IDNCT05159219

SponsorPopulation Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-03

View on ClinicalTrials.gov More Intracranial Hemorrhages trials