NCT07381803招募中3 期
The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)
Second Affiliated Hospital, Zhejiang University, School of Medicine1 个研究点 分布在 1 个国家目标入组 2,804 人开始时间: 2025年1月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,804
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular and cerebrovascular events (MACCE)
研究概览
简要总结
The goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Able to verbally confirm understanding of the trial risks, benefits, and treatment options of fexofenadine hydrochloride therapy. He/she or his/her legal representative must provide written informed consent prior to participating in the clinical trial.
- •Acute ST-segment elevation myocardial infarction (STEMI) occurring within 7 days, with diagnostic criteria including:
- •i) Typical clinical symptoms: such as severe crushing pain in the retrosternal or precordial area, usually lasting more than 10-20 minutes, which may radiate to the left upper arm, jaw, neck, back, or shoulders, etc.; ii) Elevated serum cardiac troponin (cTn): at least one measurement above the upper limit of normal (99th percentile of the reference upper limit); iii) ST-segment elevation: new ST-segment elevation at the J point in 2 adjacent leads.
- •Echocardiography indicating segmental wall motion abnormalities.
排除标准
- •Need for long-term use of fexofenadine hydrochloride or other H1 receptor inhibitors.
- •Previous coronary artery bypass grafting (CABG) surgery.
- •History of severe renal failure with estimated glomerular filtration rate (eGFR) < 30 ml/min.
- •History of severe liver dysfunction.
- •History of concurrent severe infection, hepatobiliary obstruction, or malignant tumor.
- •Expected life expectancy of less than 2 years due to non-cardiac diseases.
- •Currently receiving immunosuppressive therapy.
- •Pregnant, potentially pregnant, or lactating women.
- •Contraindication to the study drug or examinations.
- •Failure to provide written informed consent.
- •Presence of mechanical complications (ventricular septal defect, papillary muscle dysfunction, acute mitral regurgitation), refractory cardiogenic shock unresponsive to vasopressors, acute left heart failure or pulmonary edema, or malignant arrhythmias uncontrolled by antiarrhythmic drugs at enrollment.
研究组 & 干预措施
Fexofenadine
Experimental
60mg, BID
干预措施: Fexofenadine 60 Mg Oral Tablet (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Major adverse cardiovascular and cerebrovascular events (MACCE)
时间窗: 24 months
MACCE within 24 months after randomization, including all-cause death, recurrent myocardial infarction, stroke, hospitalization for heart failure, outpatient or emergency visits due to worsening heart failure, and repeat revascularization driven by angina pectoris.
次要结局
- All-cause death(24 months, 60 months after myocardial infarction)
- Recurrent myocardial infarction(24 and 60 months after myocardial infarction)
- Stroke(24 and 60 months after myocardial infarction)
- Hospitalization for heart failure(24 and 60 months after myocardial infarction)
- Repeat revascularization driven by angina pectoris(24 and 60 months after myocardial infarction)
- Left ventricular ejection fraction (LVEF%)(24 months after myocardial infarction)
- Left ventricular end-systolic diameter (LVIDs)(24 months after myocardial infarction)
- Left ventricular end-diastolic diameter (LVIDd)(24 months after myocardial infarction)
研究者
研究点 (1)
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