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

NCT06342609 | Completed Phase 4 FDA Drug

• 1 other identifier: 32857-01-EKSTROM
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (4)

• Effect of Colchicine on markers of inflammation using laboratory tests

  12 months

• Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA

  12 months

• Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA

  12 months

• Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD)

  12 months

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

0.5 milligram (mg) per day of Colchicine orally administered over the period of 52 weeks

Drug: Colchicine 0.5 MG

Placebo

PLACEBO COMPARATOR

0.5mg per day of Placebo orally administered over the period of 52 weeks

Drug: Colchicine 0.5 MG

Interventions

Colchicine 0.5 MG DRUG

0.5mg per day of Colchicine orally administered

Also known as: Mitigare, Colcrys

Colchicine; Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (1)

• Verghese 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.

  PMID: 39029568 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Matthew Budoff, MD

  The Lundquist Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Double blind Placebo controlled

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: April 2, 2024
• Study Start: March 15, 2023
• Primary Completion: September 7, 2024
• Study Completion: September 7, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)