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:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT02539160
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years.
* Type 2 DM, defined according to World Health Organization (WHO) definition, on treatment with oral hypoglycemic agents and/or insulin for at least 2 months without any changes in treatment regimen;
* Angiographically documented CAD.
* On treatment with low-dose aspirin (81mg/day) and clopidogrel (75mg/day) for at least 30 days as part of standard of care.
Exclusion Criteria:
* Patients with end-stage renal disease on hemodialysis.
* Use of any antiplatelet therapy (except aspirin and clopidogrel) in past 30 days.
* Use of parenteral or oral anticoagulation in past 30 day.
* Active pathological bleeding.
* History of intracranial hemorrhage with prior hemorrhage stroke.
* Blood dyscrasia or bleeding diathesis.
* Any active malignancy.
* Platelet count \< 80x106/µl.
* Hemoglobin \<10 g/dl.
* Known hepatic dysfunction (known moderate and severe hepatic dysfunction).
* Hemodynamic instability.
* Known allergy or hypersensitivity to ticagrelor or any excipients.
* Pregnant / lactating females (women of childbearing age must use reliable birth control while in the study).
* Strong inhibitors of cytochrome CYP3A4 and potent inducers of cytochrome CYP3A4 (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin.
* Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02539160
Study Brief:
Protocol Section:
NCT02539160