Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT)

Last updated: December 12, 2023
Sponsor: Wuhan Union Hospital, China
Overall Status: Completed

Phase

4

Condition

Chest Pain

Angina

Coronary Artery Disease

Treatment

Placebo

Colchicine

Clinical Study ID

NCT04848857
CTACS202001
  • Ages 18-80
  • All Genders

Study Summary

Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction. We hypothesized that this might be due to the improvement of the coronary plaque stability by colchicine. Optical coherence tomography (OCT) is the most precise method to detect plaque stability in clinical practice. Thus, the purpose of this study is to evaluate the efficacy and safety of colchicine on improving the stability of coronary plaque in patients with acute coronary syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants who understand and sign the informed consent form voluntarily.
  2. Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
  3. hospitalized patients diagnosed with acute coronary syndrome within 1 month.
  4. at least one non-culprit lesion with diameter stenosis percentage of 30% to 70% byvisual estimation on coronary angiography (CAG) after completing any plannedpercutaneous revascularization.
  5. the lesion shown by OCT was lipid-rich plaque (Lipid pool arc > 90 °).

Exclusion

Exclusion Criteria:

  1. Allergic to colchicine.
  2. Colchicine was taken within 10 days before randomization.
  3. Abnormal liver function (ALT > 3 times the upper limit of normal value).
  4. Abnormal renal function (creatinine clearance rate < 45 ml/min).
  5. Thrombocytopenia (PLT < 100G/L).
  6. Uncontrolled infectious diseases during the screening period.
  7. Known immune diseases or immune-related diseases such as systemic lupus erythematosus,asthma, inflammatory bowel disease, gout, malignant tumor and so on.
  8. Pre-existing or plan for the administration of systemic anti-inflammatory treatmentssuch as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory andchemotherapeutic drugs.
  9. History of surgery or interventional therapy within 6 months prior to the screeningperiod.
  10. A history of coronary artery bypass grafting or a plan for coronary artery bypassgrafting within 1 year.
  11. Left main coronary disease (≥50% reduction in lumen diameter by angiographic visualestimation).
  12. Significant coronary calcification or tortuosity deemed to preclude OCT evaluation.
  13. Diagnosed with mental disorders such as anxiety or depression.
  14. Pregnant women, lactating women or women of childbearing age who do not use effectivecontraceptive methods.
  15. Participated in other clinical trials within 3 months before the screening period.
  16. Do not receive standardized treatment after being diagnosed with coronary heartdisease.
  17. The life expectancy of the subjects is less than 1 year.
  18. The researchers determined that other conditions in which the patient was not suitableto participate in the clinical trial.

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
May 03, 2021
Estimated Completion Date:
October 05, 2023

Study Description

This is a single-center, randomized, double-blind, placebo-controlled clinical trial. OCT coronary images analyzed at an independent imaging core laboratory (Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China) by blinded expert readers.

Connect with a study center

  • Wuhan Union Hospital

    Wuhan, Hubei
    China

    Site Not Available

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