Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT07232069
Eligibility Criteria:
Inclusion Criteria:
1. Women aged 40-60 years; Men aged 30-50 years
2. Willing and able to provide informed consent and comply with study procedures
3. Smart phone user
4. Use of highly effective contraception by females with reproductive potential.
5. CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\<100 if known; elevated CAC on baseline CCTA is not exclusionary in the known plaque arm)
6. Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab
Exclusion Criteria:
1. 1\. Clinical diagnosis of ASCVD Diagnosis (MI, stroke, arterial revascularization) or current symptoms thought to be from coronary artery disease
2. PREVENT ASCVD 10-year risk \>5% (if known)
3. Diabetes Mellitus (DM) as defined by any of the following: new DM diagnosis in the medical record, new anti-diabetic medication, or HbA1C of 6.5% or greater. (if known)
4. LDL-C ≥190mg/dL (most recent, if known)
5. HIV (if known)
6. Severe liver disease or Hepatitis C infection (if known)
7. Pregnancy, lactation or intending to become pregnant during the study period of 2 years
8. eGFR \<45mL/min/1.73m2 (if known)
9. BMI\>40kg/m2
10. Allergy to iodinated intravenous contrast or other contraindication to CCTA
11. Current or previous use of lipid lowering therapy or anti-inflammatory therapy, including colchicine
12. Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.
13. PREVENT ASCVD 10-year risk ≥5%
14. eGFR \<45 ml/min/1.73m2 per baseline labs
15. Hemoglobin A1c ≥6.5% per baseline labs
16. LDL-C ≥190mg/dL per baseline labs
17. Severe proximal coronary artery stenosis as determined by the central core lab
18. Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT07232069
Study Brief:
Protocol Section:
NCT07232069