NCT06587737Not yet recruitingPhase 3
Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage
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
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1125 (estimated)
- First submitted
- 29 Aug 2024
- Start date
- 30 Sept 2026
- Primary completion date
- 30 Jul 2028
- Lead sponsor
- Population Health Research Institute
- Diseases
- Stroke
- NCT number
- NCT06587737
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1125
- From 30 Sept 2026 to the primary completion date, 30 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ICH volume more than 60ml in the last imaging scan prior to consent
- 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)
Other illness
- secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
- inflammatory bowel disease or chronic diarrhea
- known allergy or sensitivity to colchicine
Lab values
- renal insufficiency (eGFR\<15mL/min)
Other
- Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent
- cirrhosis or severe hepatic dysfunction
- pregnancy or breast-feeding
- 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
Who the study is looking for
- Adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories:
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.