EUCTR2018-003676-12-DK进行中（未招募）1 期
A phase IIa, placebo-controlled, double blind, randomised multicentre pilot study to investigate the efficacy, safety and tolerability of the monoclonal antibody ATH3G10 in patients with ST-elevation myocardial infarction
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Provision of informed consent
- •2. Symptoms and signs consistent with acute MI and ST elevation at the J-point in two
- •contiguous leads (cut-points: >0.2mV in men and >0.15 mV in women in leads V2-V3 and/or
- •>0.1 mV in other leads)
- •3. Start of PCI, defined as when the guide wire is passed through the stenosis, less than 4 hours after symptom onset. Symptom onset defined as the time of the start of the pain that causes the call to the ambulance.
- •4. TIMI flow grade 0 at angiography before PCI in left anterior descending coronary artery (segment 6 or 7) without collaterals OR TIMI flow grade less than 3 in any infarct related main coronary arteries after PCI
- •5. Age 40-85, inclusive
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Non-ST segment elevation in ECG (NSTEMI).
- •2. Cardiogenic chock, non-compensated acute heart failure and/or pulmonary oedema.
- •3. Previous major vascular intervention within the last 4 weeks.
- •4. History of an infarct in the same segment that is currently affected.
- •5. Thrombolysis therapy prior to admission.
研究者
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