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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT02052635
Eligibility Criteria:
Inclusion Criteria:
* Hospitalised for chest pain and potential acute coronary syndrome.
* Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
* Females must be either surgically sterile or post-menopausal.
* Activated Clotting Time (ACT) \</= 300 at the time of study treatment
Exclusion Criteria:
* Participation in another clinical study with an investigational product during the last 30 days.
* Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
* Any contraindication to ticagrelor, clopidogrel or bivalirudin.
* ST elevation myocardial infraction within 24 hours of study entry.
* Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
* Planned use of omeprazole or esomeprazole.
* Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication.
* Patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed.
* Use of Intravenous (IV) heparin less than 2 hours before procedure.
* Sustained uncontrolled high blood pressure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT02052635
Study Brief:
Protocol Section:
NCT02052635