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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-09-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of ACuTe Coronary Syndromes With Low-dose colchICine

NCT06215989

Acute Coronary Syndrome Unstable Angina ST Elevation Myocardial Infarction +2 more

RECRUITING NA

SB-480848 In Subjects With Coronary Heart Disease

NCT00269048

Atherosclerosis

COMPLETED PHASE2

Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events

NCT05360446

Coronary Artery Disease

ACTIVE_NOT_RECRUITING PHASE3

Efficacy Study of Oral L-Citrulline in Patients Taking Simvastatin With Peripheral Arterial Disease

NCT00351286

Peripheral Arterial Disease Intermittent Claudication

UNKNOWN PHASE2

Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardial Ischemia and Needing Coronarography

NCT04338165

Atherosclerotic Cardiovascular Disease

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind Placebo controlled

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colchicine

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

Group Type ACTIVE_COMPARATOR

Colchicine 0.5 MG

Intervention Type DRUG

0.5mg per day of Colchicine orally administered

Placebo

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

Group Type PLACEBO_COMPARATOR

Colchicine 0.5 MG

Intervention Type DRUG

0.5mg per day of Colchicine orally administered

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colchicine 0.5 MG

0.5mg per day of Colchicine orally administered

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mitigare Colcrys

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 30-85 years
2. Proven coronary artery disease; as evidenced by coronary angiography, CT coronary angiography or a Coronary Artery Calcium Score (Agatston score \>400).
3. Clinically stable for at least six months
4. Patients should have no major competing co-morbidities or contra-indication to colchicine therapy
5. Patients must be considered to be compliant with their usual therapy
6. Willingness to be on birth control for women of childbearing age or established postmenopausal for at least 1 year
7. Patients must provide written informed consent after the scope and nature of the investigation has been explained to them.
8. Patients must be considered to be compliant with their usual therapy
9. Patients must provide written informed consent after the scope and nature of the investigation has been explained to them.
10. Patients must be able and willing to comply with the requirements of this study protocol

Exclusion Criteria

1. Women who are pregnant, breast feeding or may be considering pregnancy during the study period
2. Renal impairment as evidenced by a serum creatinine \>150 μmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2
3. Severe heart failure - systolic or diastolic New York Heart Association Functional classification 3 or 4
4. Moderate or severe valvular heart disease considered likely to require intervention
5. Dependency, frailty or a predicted life expectancy \< 5 years
6. Peripheral neuritis, myositis or marked myo-sensitivity to statins
7. Requirement for long term colchicine therapy for any other reason
8. Current enrollment in another trial
9. Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patients with chronic diarrhea
10. 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
11. 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.
12. Patients already taking long term colchicine therapy for any other reason
13. History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
14. Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI.
15. Allergy to contrast material

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No