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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07392151
Eligibility Criteria:
Inclusion Criteria:
* Chronic coronary syndrome with documented coronary artery disease. In the case of previous myocardial infarction, at least 30 days between the event and randomization is required.
* Prediabetes defined as HbA1c 42-47 mmol/mol (IEC criteria) OR normoglycemia defined as HbA1c \<39 mmol/mol
* Age 18 to 80 years
Exclusion Criteria:
* eGFR \<30 mL/min/1.73 m2
* Previous diabetes diagnosis, previous HbA1c \>47 mmol/mol, or current/previous usage of diabetes medication
* Anemia, recent bleeding or blood transfusion (\<3 months)
* Previous pancreatitis
* Pregnancy, breastfeeding, or fertile women who do not use highly effective contraception
* Strongly reduced liver function
* Chronic alcohol abuse
* Known hemoglobinopathy and other conditions with effect on erythrocyte lifespan
* Intake of medications with known effect on HbA1c validity such as: antiretroviral medications, trimethoprim, sulfamethoxazole, sulfasalazine hydroxyurea, dapsone, acetylsalicylic acid (\>3 g/daily), high dose vitamin C and E.
* Heart failure with NYHA class III or IV Trial subjects must be capable of giving informed consent as assessed by the investigator.
Patients with BMI\<25 kg/m2 will be assessed individually by an investigator for eligibility (e.g., whether initiation of a GLP-1 RA with potential weight loss is clinically justifiable).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07392151
Study Brief:
Protocol Section:
NCT07392151