NL-OMON49794已完成2 期
A Phase-2 open label study to assess the pharmacodynamic and pharmacokinetic properties of a single subcutaneous injection of RUC-4 in patients with ST-elevation myocardial infarction presenting to cardiac catheterization lab with planned primary coronary angioplasty - CEL-02
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
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 with STEMI, presenting with persistent chest pain (>30 min) and
- •ongoing >= 1 mm ST-segment elevation in two adjacent ECG-leads, with > 6 mm
- •cumulative ST-segment deviation, in whom the total duration of symptom to first
- •intracoronary device deployment (excluding a wire) is anticipated to be within
- •- Adult males and females 18 years of age or older
- •- Females must be non-pregnant, non-lactating, and of non-childbearing
- •potential (postmenopausal or surgically sterilized)
- •- Weight (by history) of between 52 and 120 kg
- •- Written informed consent (following short-form of the informed consent form
排除标准
- •- High probability in the opinion of the cardiologist that current STEMI is
- •caused by stent thrombosis and the previous PCI related to this stent
- •thrombosis is < 1 month
- •- High suspicion of COVID-19 infection (known exposure, hypoxia, fever, cough)
- •- High suspicion of type II MI
- •- Out of hospital cardiac arrest (OHCA)
- •- Therapy resistant cardiogenic shock (systolic blood pressure <= 80 mm Hg for >
- •30 minutes)
- •- Persistent severe hypertension (systolic blood pressure > 180 mm Hg or
- •diastolic blood pressure > 110 mm Hg)
- •- Presentation with atrial fibrillation de novo
- •- Known severe liver disease
- •- Known history of severe renal dysfunction (glomerular filtration rate < 30
- •mL/min or serum creatinine > 200 mmol/L [> 2.5 mg/dL])
- •- Known left bundle branch block
- •- Requirement of oral anticoagulation (Vitamin K antagonists {VKA} or direct
- •oral antagonists {DOACs})
- •- Chronic use of P2Y12 antagonists
- •- Current treatment with aIIbβ3 receptor antagonist (other than RUC-4)
- •- Coagulation abnormality, known bleeding disorder, or history of documented
- •prior hemorrhagic or thrombotic stroke < 6 months
- •- History of upper or lower GI bleeding within the past 6 months
- •- Known clinically important anemia
- •- Known clinically important thrombocytopenia (platelet count of less than
- •150,000/µL)
- •- Known history of allergy to any of the ingredients in the RUC-4 formulation
- •(i.e., acetate buffer, sucrose)
- •- Major surgery within the past 6 months
- •- Life expectancy of less than 6 months
- •- Any clinically significant abnormality identified prior to enrollment that in
- •the judgment of the Investigator would preclude safe completion of the study
- •- Unwillingness or inability to comply with the requirements of this protocol
- •including the presence of any condition (physical, mental, or social) that is
- •likely to affect the patient's ability to comply with the
- •study protocol.
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