NCT06577519招募中3 期
Efficacy and Safety of Vicagrel in Patients With With Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI): a Multi-center, Randomized, Double-blind, Double-dummy , Parallel-controlled, Phase III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- The incidence of MACE
研究概览
简要总结
This is a multi-center, randomized, double-blind, double-dummy, parallel-controled, phase III trial, aiming to evaluate the effectiveness and safety of long-term continuous administration of Vicagrel capsules in ACS patients undergoing PCI.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 80 years old, with no gender restrictions.
- •Patients diagnosed with ACS and scheduled for PCI, including STEMI and NSTE-ACS (UA/NSTEMI).
- •Voluntarily sign the ICF and be able to follow the visit arrangements specified in the protocol during the trial period.
排除标准
- •Expected survival time<12 months;
- •Severe liver dysfunction (non heart disease induced ALT or AST>3x ULN) and cirrhosis;
- •Pregnant or lactating women, or participants and their partners who plan to become pregnant during the trial period;
- •The researchers determined that other reasons were not suitable for participants in this experiment.
研究组 & 干预措施
Experimental group
Experimental
Vicagrel loading followed by Maintenance dose
干预措施: Vicagrel (Drug)
Control group
Active Comparator
Clopidogrel loading followed by Maintenance dose
干预措施: Clopidogrel (Drug)
结局指标
主要结局
The incidence of MACE
时间窗: 6 month
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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