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

Official title

A Double-blind, Randomized, Placebo-controlled, Phase III Study for Reducing Dependency and Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous Intracerebral Hemorrhage and Established, or Risk Factors for, Atherosclerosis

Overview

Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors. The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.

Interventions

• Drug Colchicine 0.5 MG
  colchicine 0.5mg once-daily
• Drug Placebo
  matching placebo, lacking active ingredient, once-daily

Primary outcome measures

• Efficacy: MACE and Dependency [Time frame: through study completion, an average of 36 months]
• Safety: Symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates [Time frame: through study completion, an average of 36 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06587737 · CoVasc-ICH2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗