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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT00819403
Eligibility Criteria:
Inclusion Criteria:
1. Men and women greater than or equal to 21 years of age
2. Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:
* abdominal obesity, given as waist circumference for men \> 102 cm, and for women \> 88 cm
* triglycerides \> 150 mg/dL
* HDL cholesterol \< 40 mg/dL for men, and \< 50 mg/dL for women
* blood pressure \> 130/85 mm Hg
* fasting glucose \> 100 mg/dL
Exclusion Criteria:
1. Patients will be excluded for a history of bleeding diathesis
2. drug or alcohol abuse
3. prothrombin time greater than 1.5 times control
4. platelet count \< 100,000/mm3
5. hematocrit \< 25%
6. creatinine \> 4.0 mg/dl
7. surgery or angioplasty performed within 3 months or planned for the future
8. history of gastrointestinal or other bleeding
9. history of drug-induced disorders
10. trauma, cancer, rheumatic diseases, coronary artery disease or stroke
11. Patients participating in other investigational drug trials within one month of completion will be also excluded
12. Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months
13. Patients treated with statins or aspirin within past four weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00819403
Study Brief:
Protocol Section:
NCT00819403