EUCTR2019-004282-41-NL进行中（未招募）1 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 trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with STEMI, presenting with persistent chest pain (>30 min) and = 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 6 hours
- •- 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 at CCL)
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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
- •- Current active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
- •- 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)
- •- 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 aIIbß3 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.
研究者
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