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
- Enrolling By Invitation
- 入组人数
- 25,000
- 试验地点
- 1,353
- 主要终点
- 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.
详细描述
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
- 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
- •Main Inclusion Criteria:
- •Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization.
- •Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors:
- •Second prior AMI,
- •Diabetes mellitus defined by ongoing glucose lowering treatment,
- •Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage,
- •Peripheral artery disease at any time prior to randomization,
- •Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
- •Successful self-administered placebo according to the autoinjector instruction for use training during screening.
排除标准
- •Increased risk of serious bleeding including any of the following:
- •History of intracranial bleed at any time.
- •Known uncorrected intracranial vascular abnormality.
- •Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening.
- •Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
- •Known liver impairment significantly affecting the hepatic function.
- •Current dialysis.
- •Ischemic stroke or transient ischemic attack within 3 months of screening.
- •Chronic anemia with hemoglobin < 10 g/dL.
- •Chronic thrombocytopenia with platelet count < 100,000/mm
- •Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
- •Previous exposure to an investigational drug within 3 months prior to randomization.
- •Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.
研究组 & 干预措施
Placebo
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
干预措施: Placebo (Combination Product)
Selatogrel
Study treatment administration may occur at any time between the randomization visit and the final study visit when the participant experiences symptoms suggestive of an acute myocardial infarction. Study treatment administration triggers protocol pre-defined assessments or visits.
干预措施: Selatogrel (Combination Product)
结局指标
主要结局
Clinical status as assessed by a 6-point ordinal scale
时间窗: Total duration: up to 7 days
The clinical status will be assessed using a 6-point ordinal scale after any study treatment self-administration. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 6 mutually exclusive outcomes ranked from worst to best are: 1. Death (all causes), within 7 days after study treatment administration. 2. Acute myocardial infarction with compromised electro-hemodynamics, within 2 days after study treatment administration. 3. ST-Elevation Myocardial Infarction (STEMI), within 2 days after study treatment administration. 4. High-risk Non-ST-Elevation Myocardial Infarction (NSTEMI), within 2 days after study treatment administration. 5. NSTEMI with peak cardiac troponin greater than 10 times upper limit of normal, within 2 days after study drug administration. 6. None of the above
Occurrence of Type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition
时间窗: Total duration: up to 2 days
The number of: * Type 3 treatment-emergent bleeding events and * Type 5 treatment-emergent bleeding events will be assessed according to the Bleeding Academic Research Consortium (BARC) definition (Mehran et al. 2011), within 2 days after study treatment administration. The Bleeding Academic Research Consortium (BARC) definitions are: * Type 3, bleeding is divided into 3 categories, a through c, and includes clinical, laboratory, and/or imaging evidence of bleeding with specific healthcare provider responses. * Type 5, bleeding is fatal.
次要结局
- Occurrence of death, non-fatal acute myocardial infarction, hospitalization or unplanned emergency department visit for heart failure (Composite endpoint)(Total duration: up to 30 days)