跳至主要内容
临床试验/NCT03820466
NCT03820466终止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

Dr. med. Mahir Karakas7 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年2月21日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Aspirin 100 mg once daily and Placebo Atorvastatin once daily

干预措施: Aspirin (Drug)

Aspirin

Active Comparator

Aspirin 100 mg once daily and Placebo Atorvastatin once daily

干预措施: Placebo Atorvastatin (Drug)

Atorvastatin

Active Comparator

Atorvastatin 20 mg once daily and Placebo Aspirin once daily

干预措施: Atorvastatin (Drug)

Atorvastatin

Active Comparator

Atorvastatin 20 mg once daily and Placebo Aspirin once daily

干预措施: Placebo Aspirin (Drug)

Aspirin-Atorvastatin

Experimental

Aspirin 100 mg once daily and Atorvastatin 20 mg once daily

干预措施: Aspirin (Drug)

Aspirin-Atorvastatin

Experimental

Aspirin 100 mg once daily and Atorvastatin 20 mg once daily

干预措施: Atorvastatin (Drug)

Placebo

Placebo Comparator

Placebo Aspirin once daily and Placebo Atorvastatin once daily

干预措施: Placebo Aspirin (Drug)

Placebo

Placebo Comparator

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

发起方
Dr. med. Mahir Karakas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. Mahir Karakas

Coordinating Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (7)

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