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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT03161002
Eligibility Criteria:
Inclusion Criteria:
(I)Chinese Healthy Volunteers
* In accordance with the inclusion criteria for each bioequivalence trial of ticagrelor;
* Sign informed consent of the research;
* Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug.
(II)Chinese Patients
* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;
* More than 18 years of age, male or female;
* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuouslyï¼›
* sign informed consent.
Exclusion Criteria:
(I)Chinese Healthy Volunteers
* In accordance with the exclusion criteria for each bioequivalence trial of ticagrelor;
(II)Chinese Patients
* With history of immunodeficiency disease, including positive HIV index;
* Positive Hepatitis B surface antigen (HBsAg) and HCV index;
* Combined therapy of CYP3A potent inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, Atazanavir, etc.), CYP3A substrate of narrow therapy window (e.g., cyclosporine, quinidine, etc.) and potent inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine, etc.) in 14 days before treatment with ticagrelor;
* Severe liver dysfunction and abnormal renal function;
* Uncontrolled hypertension, or systolic blood pressure \> 180mmHg or diastolic pressure \> 110mmHg during screening;
* Include contraindications of ticagrelor, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03161002
Study Brief:
Protocol Section:
NCT03161002