Routine Use of Potassium Competitive Acid Blocker Versus Guideline-Directed Gastrointestinal Protection Strategy in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention on Dual Antiplatelet Therapy: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Net Adverse Clinical Events (NACE)
研究概览
简要总结
This study aims to compare the clinical outcomes between routine use of potassium competitive acid blocker (P-CAB) and guideline-directed gastrointestinal (GI) protection strategy in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and being treated with dual antiplatelet therapy (DAPT).
详细描述
This is a prospective, open-label, two-arm, randomized, multi-center trial. A total of 5,000 patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and receiving dual antiplatelet therapy (DAPT) will be enrolled and randomized in a 1:1 ratio. Patients will be assigned to either the routine use of P-CAB group or the guideline-directed GI protection strategy group. The primary endpoint is the occurrence of Net Adverse Clinical Events (NACE), a composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 3-5 bleeding at 1 year.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years or older.
- •Patients diagnosed with acute myocardial infarction (ST-segment elevation myocardial infarction [STEMI] or non-ST-segment elevation myocardial infarction [NSTEMI]).
- •Patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) or drug-coated balloons (DCB).
- •Patients (or their legal representatives) who understood the study risks and benefits and provided voluntary written informed consent.
排除标准
- •History of hypersensitivity (e.g., allergic reaction, anaphylactic shock) or contraindication to study drugs (potassium-competitive acid blocker [P-CAB] or proton pump inhibitor [PPI]).
- •Presence of active gastrointestinal bleeding.
- •Pregnant or breastfeeding women.
- •Non-cardiac life expectancy of less than 1 year or patients expected to have low compliance (as determined by the investigator's medical judgment).
- •Patients who refuse to participate or are unable to follow the requirements specified in the study protocol.
研究组 & 干预措施
Routine Potassium Competitive Acid Blocker Group
干预措施: Zastaprazan (Drug)
Guideline-Directed Gastrointestinal Protection Group
干预措施: Proton Pump Inhibitors (PPI) (Drug)
结局指标
主要结局
Net Adverse Clinical Events (NACE)
时间窗: 1 year
A composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3-5 bleeding.
次要结局
未报告次要终点