EUCTR2008-005140-16-NL进行中（未招募）不适用
Inhibition of d-PROTEin kinase C for the reducTION of infarct size in Acute Myocardial Infarction (PROTECTION AMI) - PROTECTION AMI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,058
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
- •a. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- •b. Subject is at least 18 years old.
- •c. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test confirmed before randomization. WOCBP must be willing to use an acceptable method of contraception to avoid pregnancy for 10 days after randomization.
- •d. Subject presents with acute STEMI and has a planned emergent primary PCI procedure.
- •e. Subject must have a minimum of 30 minutes of continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset.
- •f. Subject must have persistent ST elevation of: = 2 mm in at least two contiguous precordial leads indicative of anterior MI location (leads V1-V4; anterior STEMI cohort) or persistent ST elevation of = 2 mm in two inferior leads (leads II, III or aVF) coupled with ST depression in two contiguous anterior leads for a total of at least 8 mm (inferior STEMI cohort).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Intraventricular conduction defect (including left bundle branch block), or paced rhythm that would obscure the diagnosis of acute STEMI.
- •b. Persistent systolic blood pressure <90 mm Hg (i.e., unresponsive to IV fluids).
- •c. Currently receiving vasopressors (e.g., norepinephrine) or inotropes (e.g., dobutamine).
- •d. History of end stage renal disease requiring hemodialysis or peritoneal dialysis.
- •e. Known history of severe hepatic dysfunction (e.g., cirrhosis, ascites) or clinically jaundiced at randomization.
- •f. Any prior coronary artery bypass grafting (CABG).
- •g. Treatment with intravenous fibrinolytic therapy (e.g., alteplase, reteplase, tenecteplase, and streptokinase) within the 72 hours prior to presentation.
- •h. Women who are pregnant or breast-feeding.
- •i. Inability to comply with study procedures, including inability to undergo cardiac catheterization or primary PCI.
- •j. Serious concurrent medical condition (e.g. malignancy) likely to result in death during next 12 months.
- •k. Participation in a study of experimental therapy (drug or device) within 30 days of presentation.
- •l. Clinical suspicion of non-thrombotic (e.g., pericarditis, vasospasm, illicit drug use) cause for ST-segment elevation as determined by the Investigator.
- •m. Prior participation in this study.
- •n. Prisoners or subjects who are involuntarily incarcerated.
- •o. Subjects who are compulsorily detained for the treatment of either psychiatric or physical (e.g., infectious disease) illness.
研究者
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