Effect of platelet inhibition and / or Lipid lowering in non-ACS-patients with acute chest pain, and high-sensitivity troponin values above the 99th percentile (GRAY-ZONE)

血小板抑制和/或降脂对患有急性胸痛且高敏肌钙蛋白值高于第 99 个百分位数（灰色区域）的非 ACS 患者的影响

• 批准号: 318488553
• 负责人: Professor Dr. Mahir Karakas
• 金额: --
• 依托单位: Klinik für Kardiologie, Angiologie und Pulmologie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/318488553?language=en
• 关键词: Effect; platelet; inhibition; Lipid; lowering

Current databases show, that high-/ ultra sensitive (hs)/ (us) troponin levels above the 99th percentile in patients presenting with chest pain are indicative for future cardiovascular events, even when acute coronary syndrome (ACS) was ruled out. As published earlier this year, during a 6-month period of consecutive recruitment at the chest pain unit (CPU) Heidelberg, 406 patients with ACS and 442 patients without ACS, but an hs troponin value above the 99th percentile were identified. Alarmingly, the 450- day event-rate in this non-ACS cohort was 14% -comprising only cardiovascular death and myocardial infarction (MI). Considering also revascularization (bypass or stent) raised event rate to 22%. Not surprisingly, most of these non-ACS-patients were discharged without specific/ preventive therapy (anti-platelet or anti-lipid), although ¿positive¿ troponin values (any value at any time during hospitalisation above the 99th percentile) seem to clearly indicate underlying myocardial ischemia. In summary, there is an unmet need and huge potential to reduce mortality and morbidity in CPU patients by specific therapy. We propose that platelet inhibition by Aspirin or lipid lowering by Atorvastatin will prevent plaque rupture and superimposition of thrombosis to coronary atherosclerosis in this population. We plan to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (ER)/ CPU with acute chest pain, but an ACS was ruled out, will be assigned randomly to Aspirin and/ or Atorvastatin versus placebo (2x2 factorial design).

目前的数据库显示，胸痛患者的高/超敏（hs）/（us）肌钙蛋白水平高于第99百分位数，提示未来可能发生心血管事件，即使排除了急性冠脉综合征（ACS）。如今年早些时候发表的，在海德堡胸痛单位（CPU）连续招募的6个月期间，确定了406例ACS患者和442例无ACS患者，但高敏肌钙蛋白值高于第99百分位数。令人担忧的是，该非ACS队列的450天事件发生率为14% -仅包括心血管死亡和心肌梗死（MI）。考虑到血运重建（旁路或支架），事件发生率上升至22%。毫不奇怪，这些非ACS患者中的大多数在出院时没有接受特异性/预防性治疗（抗血小板或抗脂质），尽管肌钙蛋白值呈<$阳性<$（住院期间任何时间的任何值高于第99百分位数）似乎清楚地表明潜在的心肌缺血。总之，通过特异性治疗降低CPU患者的死亡率和发病率的需求尚未得到满足，潜力巨大。我们认为，阿司匹林抑制血小板或阿托伐他汀降脂将防止斑块破裂和血栓形成叠加冠状动脉粥样硬化在这一人群中。我们计划进行一项对照临床试验：将3,000例肌钙蛋白阳性患者在急诊室（ER）/ CPU就诊，伴有急性胸痛，但排除了ACS，将其随机分配至阿司匹林和/或阿托伐他汀组与安慰剂组（2x2析因设计）。