NCT01327183已完成2 期
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF 2 DOSES OF RO4905417 (R1512) ADMINISTERED TO PATIENTS WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 532
- 主要终点
- Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >18 to <75 years of age
- •Non ST-elevation myocardial infarction
- •Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
- •Body mass index (BMI) </= 40 kg/m2
排除标准
- •Acute ST-elevation myocardial infarction (STEMI)
- •Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
- •Percutaneous coronary intervention (PCI) within the past 72 hours
- •Thrombolytic therapy within the past 7 days
- •Major surgery within the past 3 months
- •History of cerebral vascular disease or stroke in the past 3 months
- •Bleeding disorders
- •Inadequately controlled severe hypertension
- •Prior coronary artery bypass graft (CABG) surgery
- •Decompensated heart failure (oedema and/or rale)
- •Acute infection at screening or active chronic infection within 3 months prior to PCI
- •Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
- •Uncontrolled diabetes mellitus (HbA1C >10%) at baseline
研究组 & 干预措施
20 mg/kg RO4905417 before PCI
Experimental
干预措施: Percutaneous Coronary Intervention (PCI) (Procedure)
20 mg/kg RO4905417 before PCI
Experimental
干预措施: RO4905417 (Drug)
5 mg/kg RO4905417 before PCI
Experimental
干预措施: Percutaneous Coronary Intervention (PCI) (Procedure)
5 mg/kg RO4905417 before PCI
Experimental
干预措施: RO4905417 (Drug)
Placebo before PCI
Placebo Comparator
干预措施: Percutaneous Coronary Intervention (PCI) (Procedure)
Placebo before PCI
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI
时间窗: from baseline to 24 hours post PCI
次要结局
- Change from baseline in troponin I at 8 hours post PCI(from baseline to 8 hours post PCI)
- Peak and AUC for troponin I(24 hours post PCI)
- Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI(from baseline to 24 hours post PCI)
- Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI(from baseline to Day 120 post PCI)
- Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI(from baseline to Day 30 post PCI)
- Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)(120 days)
研究者
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