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

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04848857
Collaborator
(none)
128
1
2
26.9
4.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Colchicine in Improving the Stability of Coronary Plaque in Patients With Acute Coronary Syndrome
Actual Study Start Date :
May 3, 2021
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

colchicine (0.5mg), one pill a day, oral intake

Drug: Colchicine
colchicine is a potent anti-inflammatory drug which is currently recommended for the treatment of pericarditis and acute gout attacks, but also familial Mediterranean fever and Behçet disease. This drug acts on inflammation through inhibition of microtubule polymerization by binding free tubule dimers. Colchicine blunts monocyte and neutrophil invasion at the site of inflammation and reduces intracellular trafficking and thus the release of cytokine and production of reactive oxygen species and a variety of proteolytic enzymes.

Placebo Comparator: Control Group

placebo, one pill a day, oral intake

Drug: Placebo
the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine.

Outcome Measures

Primary Outcome Measures

  1. changes of the Thickness of fibrous cap of coronary artery plaque [12 months]

    changes of the thickness of fibrous cap of coronary artery plaque measured by OCT

Secondary Outcome Measures

  1. changes of the Average lipid arc of coronary artery plaque [12 months]

    changes of the average lipid arc of coronary artery plaque measured by OCT

  2. changes of the Macrophage accumulation in coronary artery plaque [12 months]

    changes of the macrophage accumulation in coronary artery plaque measured by OCT

  3. changes of the Incidence of thin-cap fibroatheroma (TCFA) [12 months]

    changes of the incidence of TCFA measured by OCT

  4. changes of the Minimum lumen area (MLA) [12 months]

    changes of the MLA measured by OCT

  5. changes of the percentage of lumen area stenosis [12 months]

    changes of the percentage of lumen area stenosis measured by OCT

  6. changes of the inflammatory biomarker hsCRP [12 months]

    changes of the inflammatory biomarker hsCRP

  7. changes of the cytokine IL-6 [12 months]

    changes of the cytokine IL-6

  8. the rate of All-cause death for acute coronary syndrome [12 months]

    the rate of all-cause death for acute coronary syndrome

  9. the rate of re-hospitalization for acute coronary syndrome [12 months]

    the rate of rehospitalization for acute coronary syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. Coronary angiography (CAG) showed that in addition to the culprit lesion, there was at least one lesion with 30-70% stenosis.

  5. the lesion shown by OCT was lipid-rich plaque (Lipid pool arc > 90 °).

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. During the screening period, patients with immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on.

  8. Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs outside the regimen during the study period.

  9. History of surgery or interventional therapy within 6 months prior to the screening period.

  10. A history of coronary artery bypass grafting or a plan for coronary artery bypass grafting within 1 year.

  11. More than 50% stenosis of the left main artery or severe calcification / distortion of the coronary artery are considered to affect the assessment of OCT.

  12. Diagnosed with mental disorders such as anxiety or depression.

  13. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive methods.

  14. Participated in other clinical trials within 3 months before the screening period.

  15. Do not receive standardized treatment after being diagnosed with coronary heart disease.

  16. The life expectancy of the subjects is less than 1 year.

  17. The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wuhan Union Hospital Wuhan Hubei China

Sponsors and Collaborators

  • Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiang Cheng, professor, director, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT04848857
Other Study ID Numbers:
  • CTACS202001
First Posted:
Apr 19, 2021
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2022