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 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT01304095
Eligibility Criteria:
Inclusion Criteria:
1. Evidence of stable Coronary Artery Disease
* MI \> 30 days prior to enrollment
* PCI \> 30 days prior to enrollment
* CABG \> 30 days prior to enrollment
* Angiography showing \> 50% stenosis in a major vessel, branch or bypass graft \> 30 days prior to enrollment
2. Metabolic Syndrome as evidenced by at least one of the following risk factors:
* Abdominal Obesity (elevated waist circumference)
* Men - waist circumference ≥ 40 inches (102 cm) Asians/Asian Americans ≥ 35.5 inches (90 cm)
* Women - waist circumference ≥ 35 inches (88 cm) Asians/Asian Americans ≥ 31.5 inches (80 cm)
* Atherogenic dyslipidemia (either one or both)
* Triglycerides ≥ 150 mg/dL
* Reduced HDL Men - HDL ≤ 40 mg/dL Women - HDL ≤ 50 mg/dL
* Elevated Blood Pressure (equal to or greater than 130/85)
* Elevated fasting glucose (equal to or greater than 100 mg/dL)
3. Symptoms of angina or a suspected angina equivalent (upper body chest pain, shortness of breath, fatigue)
4. Patient able to perform an exercise treadmill test (ETT)
5. Written informed consent
6. Age \> 18 years old
Exclusion Criteria:
* Unstable coronary artery disease or revascularization within 30 days of enrollment.
* Patients who have a prolonged QTc interval (\>500ms)
* Patients who have known severe liver disease
* Current or planned co-administration of strong CYP3A inhibitors (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir) OR CYP3A inducers (eg, rifampin, rifabutin, rifapentine, Phenobarbital, phenytoin, carbamazepine, and St. John's Wort) OR moderate CYP3A inhibitors (eg, diltiazem, verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products)
* Patients who are pregnant or lactating
* Patients who are likely to be noncompliant with study procedures
* Patients currently in a study, or within 30 days of participating in a study, of an investigational drug or device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01304095
Study Brief:
Protocol Section:
NCT01304095