Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (SOS AMI) Multi center, double blind, randomized, placebo controlled, parallel group study to evaluate the efficacy and safety of self administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 14,000
- 试验地点
- 6
- 主要终点
- 1. Clinical status as assessed by a 6-point ordinal scale
研究概览
简要总结
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
The purpose of this study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in participants at risk of having a recurrent AMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of symptomatic type 1 AMI STEMI or NSTEMI, no longer than 4 weeks prior to randomization.
排除标准
- •Chronic anemia with hemoglobin less than 10 g per dL.
- •Chronic thrombocytopenia with platelet count less than 100,000 per mm
- •Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
结局指标
主要结局
1. Clinical status as assessed by a 6-point ordinal scale
时间窗: Time Frame: Total duration: up to 7 days
6. None of the above
时间窗: Time Frame: Total duration: up to 7 days
1. Death (all causes), within 7 days after study treatment administration.
时间窗: Time Frame: Total duration: up to 7 days
2. AMI with compromised electro-hemodynamics, within 2 days after study treatment administration.
时间窗: Time Frame: Total duration: up to 7 days
3. STEMI, within 2 days after study treatment administration.
时间窗: Time Frame: Total duration: up to 7 days
5. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration.
时间窗: Time Frame: Total duration: up to 7 days
4. High-risk NSTEMI, within 2 days after study treatment administration.
时间窗: Time Frame: Total duration: up to 7 days
次要结局
- Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit(for heart failure (Composite endpoint) within 30 days after any self-administration)