NL-OMON48214已完成2 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 - ATH3G10 in patients with STEMI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must fulfil all of the following criteria to be included in the study:
- •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
- •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
- •--Females must be of non-childbearing potential at screening confirmed by
- •fulfilling one of the following criteria a) postmenopausal defined as
- •amenorrhea for at least 12 months, or b) documentation of irreversible surgical
- •sterilization.
排除标准
- •1. Cardiogenic chock, non-compensated acute heart failure and/or pulmonary
- •2. Previous major vascular intervention within the last 4 weeks.
- •3. History of an infarct in the same artery that is currently affected.
- •4. Thrombolysis prior to admission.
- •5. Previous treatment with ATH3G10
- •6. Weight of less than 63 kg at screening (results in dose more than 4 mg/kg
- •body weight)7.
- •8. Recent (<1 month prior to screening) or current treatment with methotrexate
- •and/or tumour necrosis factor alpha (TNF*) inhibitors such as infliximab.
研究者
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