Coronary Artery DiseasePhase 4EKSTROMNCT06342609
Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease
A Phase 4 study testing Colchicine 0.5 MG in people with Coronary Artery Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Colchicine 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 7 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-85 years
- Proven coronary artery disease; as evidenced by coronary angiography, CT coronary angiography or a Coronary Artery Calcium Score (Agatston score >400).
- Clinically stable for at least six months
- Patients should have no major competing co-morbidities or contra-indication to colchicine therapy
- Patients must be considered to be compliant with their usual therapy
- Willingness to be on birth control for women of childbearing age or established postmenopausal for at least 1 year
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- Patients must provide written informed consent after the scope and nature of the investigation has been explained to them.
- Patients must be considered to be compliant with their usual therapy
- Patients must provide written informed consent after the scope and nature of the investigation has been explained to them.
- Patients must be able and willing to comply with the requirements of this study protocol
Who cannot join
- Women who are pregnant, breast feeding or may be considering pregnancy during the study period
- Renal impairment as evidenced by a serum creatinine >150 μmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2
- Severe heart failure - systolic or diastolic New York Heart Association Functional classification 3 or 4
- Moderate or severe valvular heart disease considered likely to require intervention
- Dependency, frailty or a predicted life expectancy < 5 years
- Peripheral neuritis, myositis or marked myo-sensitivity to statins
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- Requirement for long term colchicine therapy for any other reason
- Current enrollment in another trial
- Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patients with chronic diarrhea
- Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Patient with progressive neuromuscular disease of Creatine Phosphokinase (CPK) level >3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing.
- Patients already taking long term colchicine therapy for any other reason
- History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
- Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI.
- Allergy to contrast material
Trial locations and contacts
1 site in 1 country.
United States1 site
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With STable CoROnary Artery Disease CoMpared to Placebo - EKSTROM Trial
This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications.
Read the detailed description
The goal of this study is to evaluate whether treatment with Colchicine results in greater change of low attenuation plaque volume from baseline level when compared to placebo in subjects with stable Coronary Artery Disease (CAD). The Primary objective of the study is to determine progression rates of low attenuation plaque under influence of Colchicine as compared to placebo. The study will also look to determine effects of Colchicine on the morphology and composition non -calcified coronary plaque, progression of total plaque volume, progression of high vulnerability features of plaque and to assess whether these effects are modulated by a change in HsCRP and other markers of inflammation (HsCRP, IL-6, IL-1α, IL-1β, IL-18) as well as the effect on Pericoronary adipose tissue (PCAT) and Epicardial adipose tissue (EAT) volume and well as on the endothelial function.
- Conditions
- Coronary Artery Disease
- Being tested
- Colchicine 0.5 MG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Also called Mitigare, Colcrys
0.5mg per day of Colchicine orally administered
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | 0.5 milligram (mg) per day of Colchicine orally administered over the period of 52 weeks Receives: Drug: Colchicine 0.5 MG |
| Placebo | Placebo comparator | 0.5mg per day of Placebo orally administered over the period of 52 weeks Receives: Drug: Colchicine 0.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography
Reduction of low attenuation plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CTA).
Measured: 12 months
Secondary outcomes (4)
Effect of Colchicine on markers of inflammation using laboratory tests
To determine the effect of Colchicine on markers of inflammation (IL-6, IL-1α, IL-1β, IL-18 high sensitivity C-reactive protein)
Measured: 12 months
Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA
To determine the effects of Colchicine on PCAT volume.
Measured: 12 months
Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA
To determine the effects of Colchicine on EAT volume.
Measured: 12 months
Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD)
To determine the effect of Colchicine on Endothelial function using FMD.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Mar 2023
- Primary completion7 Sep 2024
- Study completion7 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind Placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Matthew Budoff, MD, Principal investigator, The Lundquist Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342609
- Sponsor's protocol ID
- 32857-01-EKSTROM
- Acronym
- EKSTROM
- Status last verified
- Oct 2024
- First submitted
- 16 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Budoff MJ, Bhandari M, Iskander B, Ghanem AK, Kinninger A, Stark J, Garikapati V, Chilukuri S, Hankil V, Krishnan S, Punnanithinont N, Ichikawa K, Kambalapalli S, Hamal S, Lakshmanan S. Effect of colchicine on progression of known coronary atherosclerosis in patients with stable coronary artery disease: EKSTROM randomized placebo controlled trial. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):682-692. doi: 10.1093/ehjci/jeag028.
PubMed 41670023Verghese D, Hamal S, Ghanem A, Kinninger A, Javier D, Ichikawa K, Benzing T, Krishnan S, Kianoush S, Hamidi H, Bagheri M, Abraham D, Deljavanghodrati M, Ghoto A, Aldana-Bitar J, Budoff M. Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial-rationale and design. Am Heart J. 2024 Nov;277:20-26. doi: 10.1016/j.ahj.2024.07.005. Epub 2024 Jul 17.
PubMed 39029568
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With STable CoROnary Artery Disease CoMpared to Placebo - EKSTROM Trial
- ClinicalTrials.gov ID
- NCT06342609
- Acronym / sponsor ID
- EKSTROM / 32857-01-EKSTROM
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 7 Sep 2024 (actual)
- Study completion
- 7 Sep 2024 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications.
Detailed description
The goal of this study is to evaluate whether treatment with Colchicine results in greater change of low attenuation plaque volume from baseline level when compared to placebo in subjects with stable Coronary Artery Disease (CAD). The Primary objective of the study is to determine progression rates of low attenuation plaque under influence of Colchicine as compared to placebo. The study will also look to determine effects of Colchicine on the morphology and composition non -calcified coronary plaque, progression of total plaque volume, progression of high vulnerability features of plaque and to assess whether these effects are modulated by a change in HsCRP and other markers of inflammation (HsCRP, IL-6, IL-1α, IL-1β, IL-18) as well as the effect on Pericoronary adipose tissue (PCAT) and Epicardial adipose tissue (EAT) volume and well as on the endothelial function.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: Colchicine 0.5 MG0.5 milligram (mg) per day of Colchicine orally administered over the period of 52 weeks |
| Placebo | Placebo comparator | Drug: Colchicine 0.5 MG0.5mg per day of Placebo orally administered over the period of 52 weeks |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 30-85 years
- Proven coronary artery disease; as evidenced by coronary angiography, CT coronary angiography or a Coronary Artery Calcium Score (Agatston score >400).
- Clinically stable for at least six months
- Patients should have no major competing co-morbidities or contra-indication to colchicine therapy
- Patients must be considered to be compliant with their usual therapy
Key exclusion criteria (15 listed)
- Women who are pregnant, breast feeding or may be considering pregnancy during the study period
- Renal impairment as evidenced by a serum creatinine >150 μmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2
- Severe heart failure - systolic or diastolic New York Heart Association Functional classification 3 or 4
- Moderate or severe valvular heart disease considered likely to require intervention
- Dependency, frailty or a predicted life expectancy < 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MGAlso: Mitigare, Colcrys0.5mg per day of Colchicine orally administered | Drug | Colchicine, Placebo |
Primary outcome
Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography
Time frame: 12 months
Reduction of low attenuation plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CTA).
4 secondary outcomes
Effect of Colchicine on markers of inflammation using laboratory tests
Time frame: 12 months
Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA
Time frame: 12 months
Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA
Time frame: 12 months
Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41670023Budoff MJ, Bhandari M, Iskander B, Ghanem AK, Kinninger A, Stark J, Garikapati V, Chilukuri S, Hankil V, Krishnan S, Punnanithinont N, Ichikawa K, Kambalapalli S, Hamal S, Lakshmanan S. Effect of colchicine on progression of known coronary atherosclerosis in patients with stable coronary artery disease: EKSTROM randomized placebo controlled trial. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):682-692. doi: 10.1093/ehjci/jeag028.
- Derived from this study: PubMed 39029568Verghese D, Hamal S, Ghanem A, Kinninger A, Javier D, Ichikawa K, Benzing T, Krishnan S, Kianoush S, Hamidi H, Bagheri M, Abraham D, Deljavanghodrati M, Ghoto A, Aldana-Bitar J, Budoff M. Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial-rationale and design. Am Heart J. 2024 Nov;277:20-26. doi: 10.1016/j.ahj.2024.07.005. Epub 2024 Jul 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Budoff, MD principal investigator
The Lundquist Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine 0.5 MG in people with Coronary Artery Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06342609, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.