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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT06548204
Eligibility Criteria:
Inclusion Criteria:
* Ages above 18;
* Being able to verbally confirm understanding of the trial risks, benefits, and treatment options of receiving treatment with fexofenadine hydrochloride. He/she or his/her legal representative shall provide written informed consent before participating in the clinical trial.
* Meet the diagnostic criteria for STEMI, the diagnostic criteria includes:
1. Clinical symptoms: ischemic chest pain lasting for over 30 minites;
2. Elevated serum cTn: at least once higher than the upper limit of normal values (99th percentile of the reference upper limit);
3. ST segment elevation: new ST segment elevation in two or more adjacent leads on the ECG;
* Emergency coronary angiography and revascularization should be performed within 12 hours of symptom onset;
* Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.
Exclusion Criteria:
* Long term use of fexofenadine hydrochloride or other H1 receptor inhibitors;
* Previously suffered from myocardial infarction or received coronary artery bypass grafting;
* History of severe renal failure, estimated glomerular filtration rate (eGFR) \< 30ml/min;
* History of severe liver dysfunction, total bilirubin (TBil) \> the upper limit of normal, or AST/ALT \> 3 times the upper limit of normal, or alkaline phosphatase \> 2.5 times the upper limit of normal;
* Concurrent severe infections, or liver/gallbladder obstruction, or history of malignant tumors;
* Currently receiving immunosuppressive therapy;
* Pregnant or potentially pregnant and breastfeeding women;
* Contraindications for fexofenadine hydrochloride or cardiac magnetic resonance examinations;
* Without obtaining written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06548204
Study Brief:
Protocol Section:
NCT06548204