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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04237935
Eligibility Criteria:
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Market availability of ticagrelor in the U.S. started on 2011-07-20.
* For Marketscan: 2011-07-20 to 2017-12-31 (end of data availability).
* For Optum: 2011-07-20 to 2019-03-31 (end of data availability).
Inclusion Criteria:
* 1-4 ALL REQUIRED
* 1\. Hospitalized for potential ST-segment elevation or non-ST-segment elevation ACS, with onset during the previous 24 hours, documented by cardiac ischemic symptoms due to atherosclerosis of ≥10 minutes' duration at rest
* 2\. ≥18 years of age
* 3\. Not pregnant. Urinary and/or blood pregnancy tests are to be performed in women of child-bearing potential and repeated at least every 6 months. Women of child-bearing potential must be using ≥2 forms of reliable contraception, including one barrier method.
* 4\. With informed consent 1-4 AND 5A OR 5B
* 5A. ≥2 of the following:
* 1\. ST-segment changes on ECG indicating ischemia. ST-segment depression or transient elevation ≥ 1 mm in two or more 2 contiguous leads"
* 2\. Positive biomarker indicating myocardial necrosis. Troponin I or T or CK-MB greater than the upper limit of normal
* 3\. One of the following:
1. ≥60 y of age
2. Previous MI or CABG
3. CAD with ≥50% stenosis in ≥2 vessels
4. Previous ischemic stroke, TIA (hospital-based diagnosis), carotid stenosis (≥50%), or cerebral revascularization
5. Diabetes mellitus
6. Peripheral artery disease
7. Chronic renal dysfunction
* OR
* 5B. Persistent ST-segment elevation ≥1 mm (not known to be preexisting or due to a coexisting disorder) in ≥2 contiguous leads or new LBBB plus primary PCI planned.
Exclusion Criteria:
* Drug related
* 1\. Contraindication to clopidogrel or other reason that study drug should not be administered (eg, hypersensitivity, moderate or severe liver disease, active bleeding or bleeding history, major surgery within 30 days)"
* 2\. Oral anticoagulation therapy that cannot be stopped
* 3\. Fibrinolytic therapy planned or within the previous 24 h
* 4\. Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin/rifampicin, phenytoin, carbamazepine)
* Treatment related
* 1\. Index event is an acute complication of PCI
* 2\. PCI after index event and before first study dose
* Medical
* 1\. Increased risk of bradycardiac events
* 2\. Dialysis required
* 3\. Known clinically important thrombocytopenia
* 4\. Known clinically important anemia
* 5\. Any other condition that may put the patient at risk or influence study results in the investigators' opinion (eg, cardiogenic shock, severe hemodynamic instability, active cancer)
* General
* 1\. Participant in another investigational drug or device study within 30 days
* 2\. Pregnancy or lactation
* 3\. Any condition that increases the risk for noncompliance or being lost to follow-up
* 4\. Involvement in the planning or conduct of the study
* 5\. Previous enrollment or randomization in this study
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT04237935
Study Brief:
Protocol Section:
NCT04237935