Investigator-initiated, placebo-controlled, randomized trial to assess the efficacy and safety of platelet inhibition and/ or lipid lowering in non-ACS-patients with elevated high-sensitivity troponin values - Acetylsalicylic acid and statin in subclinical myocardial ischemia

niversity Medical Centre Hamburg-Eppendorf0 个研究点目标入组 3,000 人开始时间: 2019年10月4日最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•Key inclusion criteria:
•Patients presenting in the ER/ Chest Pain Unit (CPU), and expected
•to be discharged within 24 hours
•Patients at risk for cardiovascular events as defined by at least one elevated high-sensitive troponin level during clinical work-up (> 90th percentile)
•Clinical exclusion of ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
•At least 50 years of age
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1800

•Key exclusion criteria:
•Indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -CAD) or anticoagulation therapy (such as atrial fibrillation)
•Indication for anti-lipid therapy at the discretion of the treating physician (no routine measurement of LDL-cholesterol)
•Any known evidence of an acute myocardial necrosis (e.g imaging evidence of new regional wall motion abnormality, or significant ST-segment–T wave (ST–T) changes in ECG)
•Untreated, known clinically significant CAD requiring revascularization
•Hemoglobin value below 8 mg/d, and/or creatinine kinase =3 times ULN, and/or AST or ALT =3 times ULN
•Active malignancy of any organ system, treated or untreated. Subjects have to be in remission for at least 36 months to be eligible.

发起方

niversity Medical Centre Hamburg-Eppendorf