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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT05392959
Eligibility Criteria:
Inclusion Criteria:
* type 2 diabetes mellitus (T2DM) patients presenting with stable angina and a clinical indication for cardiac catheterization
* T2DM patients with non ST elevation myocardial infarction (NSTEMI) or unstable angina referred for cardiac catheterization
* Demonstration of coronary lesion(s) with non-significant fractional flow reserve (FFR) values (\>0.80), for which revascularisation is deferred
* Agreement to practice an acceptable method of birth control for women of childbearing potential
* Signed patient informed consent
Exclusion Criteria:
* Age \< 18 years old
* T2DM patients presenting with ST elevation myocardial infarction (STEMI)
* Pregnancy or breastfeeding
* Body mass index ≥45 kg/m2
* Creatinine clearance ≤45 ml/min/1.73 m2 (as calculated by Modification of Diet in Renal Disease Study (MDRD ) formula for estimated Glomerular filtration rate (GFR))
* Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal during screening or run-in phase
* Uncontrolled hyperglycemia with glucose \>240 mg/dL after an overnight fast
* Stroke, or transient ischemic attack at presentation and up to 2 months prior to informed consent
* Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
* Any uncontrolled endocrine disorder except type 2 diabetes
* Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
* Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight
* Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
* Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
* Planned cardiac surgery or angioplasty within 3 months
* Any clinical condition that would jeopardize patient safety while participating in this clinical trial
* Life expectancy \< 3 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05392959
Study Brief:
Protocol Section:
NCT05392959