Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage

Launched by POPULATION HEALTH RESEARCH INSTITUTE · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial, called CoVasc-ICH 2, is investigating whether a medication called colchicine can help improve outcomes for patients who have experienced an intracerebral hemorrhage (ICH), which is a type of stroke caused by bleeding in the brain. Researchers believe that patients who have had an ICH are at a high risk of further complications and disability, and they hope that taking colchicine daily for a short period after the event can make a difference. The study will focus on adults who show signs of or have risk factors for serious blood vessel problems.

To be eligible for this trial, participants must be adults who experienced a spontaneous ICH within the last 72 hours and meet certain health criteria, such as being over 60 years old or having a history of heart or blood vessel problems. The trial is not yet recruiting participants, but those who join can expect to take either colchicine or a placebo (a non-active pill) daily for the duration of the study. It's important to know that there are specific health conditions that would prevent someone from participating, such as severe liver problems or certain allergies. Overall, this research aims to find better ways to support recovery and reduce risks for individuals affected by ICH.

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Eligibility criteria

• Inclusion Criteria:
• Adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset 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).
• Exclusion Criteria:
• • secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
• • ICH volume more than 60ml in the last imaging scan prior to consent
• • Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent
• • inflammatory bowel disease or chronic diarrhea
• • cirrhosis or severe hepatic dysfunction
• • renal insufficiency (eGFR\<15mL/min)
• • concurrent or planned 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)
• • pregnancy or breast-feeding
• • known allergy or sensitivity to colchicine
• • a strong indication for colchicine where assignment to placebo is deemed unacceptable
• • estimated life expectancy less than 6 months at the time of enrollment, and
• • inability to adhere to study procedures