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Anti-inflammatory

Colchicine for Coronary Artery Disease (EKSTROM Trial)

Phase 4
Waitlist Available
Led By Matthew Budoff, MD
Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test if taking Colchicine 0.5mg per day is better than taking a placebo for patients with stable coronary artery disease. Participants will also be reminded to take their other prescribed

Who is the study for?
This trial is for patients with stable Coronary Artery Disease (CAD), which means their heart's blood vessels are narrowed or blocked. They should be on a steady medication routine and willing to add either Colchicine or a placebo to their treatment.
What is being tested?
The study tests if taking Colchicine, at a low dose of 0.5mg daily, can slow down the worsening of coronary artery disease compared to a dummy pill (placebo). It's randomized and double-blind, meaning neither the participants nor the researchers know who gets what.
What are the potential side effects?
Colchicine may cause side effects like diarrhea, nausea, vomiting, and abdominal pain. Rarely it can lead to muscle weakness or blood disorders. The risk of serious side effects is generally low.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography
Secondary study objectives
Effect of Colchicine on markers of inflammation using laboratory tests
Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD)
Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ColchicineActive Control1 Intervention
0.5 milligram (mg) per day of Colchicine orally administered over the period of 52 weeks
Group II: PlaceboPlacebo Group1 Intervention
0.5mg per day of Placebo orally administered over the period of 52 weeks

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
104 Previous Clinical Trials
46,499 Total Patients Enrolled
8 Trials studying Coronary Artery Disease
7,792 Patients Enrolled for Coronary Artery Disease
Matthew Budoff, MDPrincipal InvestigatorThe Lundquist Institute
7 Previous Clinical Trials
1,159 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
220 Patients Enrolled for Coronary Artery Disease
~33 spots leftby Nov 2025
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