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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT02487732
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent prior to any study specific procedures
2. Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70
3. Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)
Exclusion Criteria:
1. Hypersensitivity to ticagrelor, prasugrel or any of the excipients
2. No prior use of either ticagrelor or prasugrel within a month prior to randomization.
3. History of intracranial bleeding at any time
4. Active pathologic bleeding
5. Hemoglobin A1c \>9%
6. Type 1 diabetes
7. Decreased serum platelet level (\< 100,000/uL)
8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
9. Gastrointestinal bleed within the past 6 months, or major surgery within 30 days
10. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
11. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
12. Involvement in the planning and/or conduct of the study
13. Left ventricular ejection fraction \< 40%
14. Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit)
15. Gastrointestinal disorder such as Crohn's disease
16. Alcohol abuse
17. Steroid or hormone replacement therapy
18. Serum creatinine \> 2.0 mg/dL.
19. Prior history of CVA or stroke
20. Body weight \< 60 kg
21. Life expectancy less than a year
22. Known pregnancy, breast-feeding, or intend to become pregnant during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT02487732
Study Brief:
Protocol Section:
NCT02487732