Health TrialsbyHealthPanel

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

ConditionsColchicineICH - Intracerebral HemorrhageStrokeDependence
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Colchicine 0.5 MG

    Drug

    colchicine 0.5mg once-daily

  • Placebo

    Drug

    matching placebo, lacking active ingredient, once-daily

Treatment groups

1,125 Participants
are divided into 2 treatment groups
Group A: colchicine 0.5mg ODExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy: MACE and Dependency

Treatment with colchicine will reduce the risk for major adverse cardiovascular events (MACE) and dependency

Time frame
through study completion, an average of 36 months
2

Safety: Symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates

There will be no clinically-important change in symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates with oral colchicine 0.5mg OD compared with matching placebo

Time frame
through study completion, an average of 36 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: