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NCT06342609CompletedPhase 4

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

Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With STable CoROnary Artery Disease CoMpared to Placebo - EKSTROM Trial

Source: ClinicalTrials.gov · Last updated 15 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
84 (actual)
First submitted
16 Mar 2024
Start date
15 Mar 2023
Primary completion date
7 Sept 2024
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
NCT number
NCT06342609

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 84
  • From 15 Mar 2023 to the primary completion date, 7 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Requirement for long term colchicine therapy for any other reason
  • Patients already taking long term colchicine therapy for any other reason

Other illness

  • 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
  • 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.
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Allergy to contrast material

Lab values

  • Renal impairment as evidenced by a serum creatinine \>150 μmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2

Age

  • Dependency, frailty or a predicted life expectancy \< 5 years

Other

  • Women who are pregnant, breast feeding or may be considering pregnancy during the study period
  • Peripheral neuritis, myositis or marked myo-sensitivity to statins
  • Current enrollment in another trial
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI.

Who the study is looking for

  • 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

Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Coordinator of this site? Confirm its status
TorranceUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.