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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

EKSTROM 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.Check my eligibility

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.See study design

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.

EKSTROM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography

Secondary outcome measures

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

EKSTROM 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor

101 Previous Clinical Trials

46,217 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with Colchicine use in individuals?

"Power's evaluation ranks Colchicine with a safety rating of 3 due to its Phase 4 status, indicating official approval for therapeutic use."

Answered by AI

Does this medical study accept individuals older than 40 years?

"Individuals seeking to participate in this research must be between 30 and 85 years old to meet the age requirements for enrollment."

Answered by AI

Are there ongoing efforts to actively enlist participants for this medical study?

"As per clinicaltrials.gov, patient recruitment for this trial has ceased. The trial was first listed on 3/15/2023 and last updated on 3/28/2024. Despite the closure of this particular trial, there are currently 678 other trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease

Matthew J. Budoff 2023. "Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06342609.

All > Atherosclerosis