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 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
NCT ID:
NCT01829659
Eligibility Criteria:
Inclusion Criteria:
* Female (post menopausal or surgically sterile) and/or male aged 18 years or older
* Presenting with ACS fulfilling the following:
1. Symptoms or new ECG changes (ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG)
2. Elevation of biomarkers (CK-MB ≥2 ULN or troponin ≥ ULN)
* Self-identified as African-American
* Treatment with 75-100mg ASA daily
Exclusion Criteria:
* Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, PE, DVT) for antithrombotic treatment during study period.
* Fibrinolytic therapy within 48 hours before randomization
* Concomitant therapy with a drug having possible interaction with ticagrelor. (concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer)
* Increased bleeding risk including: recent (\<30 days) GI bleeding, any history of intracranial, intraocular, retroperitoneal, or spinal bleeding, recent (\<30 days of dosing) major trauma, sustained uncontrolled hypertension (systolic blood pressure \[SBP\]\>180mmHg or diastolic blood pressure \[DBP\]\>100mmHg), history of hemorrhagic disorders that can increase the risk of bleeding, platelet count less than 100,000 mm3 or hemoglobin \<10 g/dL.
* Any history of hemorrhagic stroke.
* Contraindication or other reason that ASA or ticagrelor should not be administered (e.g., hypersensitivity, active bleeding, major surgery within 30 days of dosing).
* Severe renal failure (creatinine clearance \<30mL/min or patient requires dialysis)
* History of moderate or severe hepatic impairment with aspartate amino transferace, alanine amino transferase or total bilirubin \> 1.5 x upper limit of the reference range.
* Pregnant or lactating women.
* Patients receiving any glycoprotein IIb/IIIa inhibitors \<8 hours before platelet reactivity testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01829659
Study Brief:
Protocol Section:
NCT01829659