DRKS00017671尚未招募3 期
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 - GRAY-ZONE
niversitäres Herzzentrum Hamburg0 个研究点目标入组 3,000 人开始时间: 2020年1月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 one（—）
- 性别
- All
入选标准
- •Patient with symptoms suggestive for ACS presenting within 48 hours after onset in the ER/ Chest Pain Unit (CPU)
- •Patient has at least one elevated hsTn I or T value
- •Symptoms are classified as non-ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
- •At least 50 years of age
排除标准
- •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
- •Any evidence of an acute myocardial necrosis (e.g imaging ev-idence of new regional wall motion abnormality, or significant ST-segment–T wave (ST–T) changes in ECG)
- •Untreated 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
研究者
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