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)

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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).