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 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT03860350
Eligibility Criteria:
Inclusion Criteria:
* CAC score \>10
* Framingham risk score (10 % or above)
* Subjects are required to be on stable concomitant medications for at least 12 weeks prior to randomization
* Subjects with diabetic must have HbA1C \< 8.0, and stable HbA1C level variation range within 0.5% for three months.
Exclusion Criteria:
* Hypersensitivity to AGE therapy,
* Unstable medical, psychiatric, or substance abuse disorder that may interfere with continuation in the study,
* Weight ≥325 pounds,
* Bleeding disorder,
* History of myocardial infarction,
* Stroke
* Life-threatening arrhythmia within prior 6 months,
* Resting hypotension (systolic \< 90 mmHg) or hypertension (resting blood pressure \>170/110)
* Heart failure NYHA class III or IV,
* History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
* Serum creatinine \>1.4 mg/dl
* Triglycerides \> 400 at baseline visit
* Diabetic subjects with HbA1C \> 8 %,
* Drug or alcohol abuse
* Conditions interfering with accurate assessment of coronary calcification (metal clips, bypass patients, intracoronary stents) and drug absorption (partial ileal bypass or malabsorption syndrome).
* Current use of anticoagulants (except for antiplatelet agents)
* Chronic renal failure
* Liver failure
* Hematological or biochemical values at baseline visit outside the reference ranges considered as clinically significant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03860350
Study Brief:
Protocol Section:
NCT03860350