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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 7
- 主要终点
- Myocardial infarction and/ or cardiovascular death and/ or revascularization
研究概览
简要总结
The study evaluates the effect of platelet inhibition and / or lipid lowering in non-ACS-patients with symptoms suggestive for ACS, and elevated high-sensitivity troponin values
详细描述
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. Most of these non-ACS-patients are 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 Chest Pain Unit patients by specific therapy. The investigators 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. It is planned to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (ER)/ CPU with symptoms suggestive for ACS, but an ACS was ruled out, will be assigned randomly to Aspirin 100 mg and/ or Atorvastatin 20 mg versus placebo (2x2 factorial design).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
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 high-sensitivity troponin I or T value
- •Chest pain is 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 evidence 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.
研究组 & 干预措施
Aspirin
Aspirin 100 mg once daily and Placebo Atorvastatin once daily
干预措施: Aspirin (Drug)
Aspirin
Aspirin 100 mg once daily and Placebo Atorvastatin once daily
干预措施: Placebo Atorvastatin (Drug)
Atorvastatin
Atorvastatin 20 mg once daily and Placebo Aspirin once daily
干预措施: Atorvastatin (Drug)
Atorvastatin
Atorvastatin 20 mg once daily and Placebo Aspirin once daily
干预措施: Placebo Aspirin (Drug)
Aspirin-Atorvastatin
Aspirin 100 mg once daily and Atorvastatin 20 mg once daily
干预措施: Aspirin (Drug)
Aspirin-Atorvastatin
Aspirin 100 mg once daily and Atorvastatin 20 mg once daily
干预措施: Atorvastatin (Drug)
Placebo
Placebo Aspirin once daily and Placebo Atorvastatin once daily
干预措施: Placebo Aspirin (Drug)
Placebo
Placebo Aspirin once daily and Placebo Atorvastatin once daily
干预措施: Placebo Atorvastatin (Drug)
结局指标
主要结局
Myocardial infarction and/ or cardiovascular death and/ or revascularization
时间窗: Until last patient has completed 12 months of follow-up
Time to myocardial infarction, coronary revascularization, or death, whatever comes first
次要结局
未报告次要终点
研究者
Dr. med. Mahir Karakas
Coordinating Principal Investigator
Universitätsklinikum Hamburg-Eppendorf
