Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Late gadolinium enhancement/Left ventricular mass (LGE/LV%)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.
详细描述
Background: Cardiac fibrosis caused by acute myocardial infarction is one of the major causes of death for cardiovascular disease patients in China. Previous research found that expression of FMO2 in heart significantly decreased after myocardial infarction. Overexpression of FMO2 in cardiac fibroblasts using lentivirus can reduce collagen deposition and improve cardiac function, which suggest that FMO2 can be a target for treating cardiac fibrosis. The investigators used the FDA drug library to screen drugs that promote FMO2 expression, then validated the top ranked candidate drug and found that fexofenadine hydrochloride had the most significant effect. Animal experiments found that fexofenadine significantly improved the heart function and reduced heart fibrosis in mice after myocardial infarction and has no significant side effects on liver or kidney function. Fexofenadine Hydrochloride is a third-generation H1 receptor antagonist mainly used to treat allergic diseases such as seasonal allergic rhinitis and chronic idiopathic urticarial. However, currently no study evaluates the efficacy and safety of fexofenadine hydrochloride in treating acute myocardial infarction in human.
Purpose: The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.
Study design: This study is a prospective, multi-center, double blind, randomized controlled clinical trial. The study objects are STEMI patients: left ventricular ejection fraction (LVEF)≤50%, and primary PCI was performed. Participants will be randomly assigned to control group and fexofenadine group in a 1:1 ratio. The control group will receive placebo 3 days after primary PCI for 6 months based on the standard treatment. The fexofenadine group will receive fexofenadine hydrochloride 60mg bid 3 days after primary PCI for 6 months on the basis of standard treatment, and both groups will be followed up for 6 months.
Outcome measure: The primary outcome is late gadolinium enhancement/left ventricular mass (LGE/LV mass%). The secondary outcomes are left ventricular ejection fraction (LVEF%), left ventricular end-systolic volume/body surface area (LVESV/BSA%), left ventricular end-diastolic volume/body surface area (LVEDV/BSA%), extracellular volume (ECV), intramyocardial hemorrhage (IMH), stroke volume, peri-infarct zone, BNP, VO2 max, SAQ scale score, drug-associated adverse events and incidence of MACE (including cardiac death, myocardial infarction, readmission due to heart failure).
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, Care Provider, Investigator)
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
- •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:
- •Clinical symptoms: ischemic chest pain lasting for over 30 minites;
- •Elevated serum cTn: at least once higher than the upper limit of normal values (99th percentile of the reference upper limit);
- •ST segment elevation: new ST segment elevation in two or more adjacent leads on the ECG;
- •Emergency coronary angiography and revascularization should be performed;
- •Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.
排除标准
- •Long term use of fexofenadine hydrochloride or other H1 receptor inhibitors;
- •Previously suffered from myocardial infarction or received coronary artery bypass grafting;
- •Patients with concomitant cardiomyopathy or valve disease;
- •History of severe renal failure, estimated glomerular filtration rate (eGFR) < 30ml/min;
- •History of severe liver dysfunction;
- •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.
- •Patients with hemodynamic instability.
研究组 & 干预措施
Placebo
Participants will receive a matched 60mg placebo tablet orally twice a day for 6 months, which was added to the standard treatment.
干预措施: Placebo (Other)
Fexofenadine hydrochloride
Fexofenadine hydrochloride 60mg bid was added to the standard treatment 3 days after the completion of primary PCI and CMR examination for 6 months.
干预措施: Fexofenadine Hydrochloride (Drug)
结局指标
主要结局
Late gadolinium enhancement/Left ventricular mass (LGE/LV%)
时间窗: 6 months after myocardial infarction
The difference of LGE/LV% from baseline. LGE/LV% will be assessed by CMR.
次要结局
- Left ventricular ejection fraction (LVEF)(6 months after myocardial infarction)
- Left ventricular internal dimension in diastole/body surface area (LVIDd/BSA%)(6 months after myocardial infarction)
- Left ventricular internal dimension in systole/body surface area (LVIDs/BSA%)(6 months after myocardial infarction)
- Incidence of MACE(1 month, 3 months and 6 months after myocardial infarction)
- BNP(6 months after myocardial infarction)
- VO2 max(6 months after myocardial infarction)
- SAQ scale score(6 months after myocardial infarction)
- Drug-associated adverse reaction(1 month, 3 months and 6 months after myocardial infarction)
- Left ventricular end-systolic volume/body surface area (LVESV/BSA%)(6 months after myocardial infarction)
- Left ventricular end-diastolic volume/body surface area (LVEDV/BSA%)(6 months after myocardial infarction)
- Extracellular volume (ECV)(6 months after myocardial infarction)
- Intramyocardial hemorrhage (IMH)(6 months after myocardial infarction)
- stroke volume(6 months after myocardial infarction)
- peri-infarct zone(6 months after myocardial infarction)
- Incidence of MACE(6 months after myocardial infarction)