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首页> 美国卫生研究院文献>Clinical Cardiology >Rationale and design of the Virginia Commonwealth University–Anakinra Remodeling Trial‐3 (VCU‐ART3): A randomized placebo‐controlled double‐blinded multicenter study
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Rationale and design of the Virginia Commonwealth University–Anakinra Remodeling Trial‐3 (VCU‐ART3): A randomized placebo‐controlled double‐blinded multicenter study

机译：弗吉尼亚联邦大学-Anakinra重塑试验-3（VCU-ART3）的原理和设计：一项随机安慰剂对照双盲多中心研究

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There is clear association between the intensity of the acute inflammatory response during acute myocardial infarction (AMI) and adverse prognosis after AMI. Interleukin‐1 (IL‐1) is a pro‐inflammatory cytokine released during AMI and involved in adverse remodeling and heart failure (HF). We describe a study to evaluate the safety and efficacy of IL‐1 blockade using an IL‐1 receptor antagonist (anakinra) during the acute phase of ST‐segment elevation myocardial infarction (STEMI). The Virginia Commonwealth University–Anakinra Remodeling Trial‐3 (VCU‐ART3; ) is a phase 2, multicenter, double‐blinded, randomized, placebo‐controlled clinical trial comparing anakinra 100 mg once or twice daily vs matching placebo (1:1:1) for 14 days in 99 patients with STEMI. Patients who present to the hospital with STEMI within 12 hours of symptom onset will be eligible for enrollment. Patients will be excluded for a history of HF (functional class III–IV), severe valvular disease, severe kidney disease (stage 4–5), active infection, recent use of immunosuppressive drugs, active malignancy, or chronic autoimmune/auto‐inflammatory diseases. We will measure the difference in the area under the curve for C‐reactive protein between admission and day 14, separately comparing each of the anakinra groups with the placebo group. The P value will be considered significant if <0.025 to adjust for multiple comparisons. Patients will also be followed for up to 12 months from enrollment to evaluate cardiac remodeling (echocardiography), cardiac function (echocardiography), and major adverse cardiovascular outcomes (cardiovascular death, MI, revascularization, and new onset of HF).
机译：急性心肌梗死（AMI）期间急性炎症反应的强度与AMI后不良预后之间存在明显的关联。白细胞介素-1（IL-1）是AMI期间释放的促炎细胞因子，参与不良的重塑和心力衰竭（HF）。我们描述了一项研究，以评估在ST段抬高型心肌梗塞（STEMI）急性期使用IL-1受体拮抗剂（anakinra）进行IL-1阻断的安全性和有效性。弗吉尼亚联邦大学-Anakinra重塑试验-3（VCU-ART3;）是第2阶段，多中心，双盲，随机，安慰剂对照的临床试验，比较了每日一次或两次安那康100 mg与匹配安慰剂的比较（1：1： 1）在99例STEMI患者中持续14天。在症状发作后12小时内到医院就诊并患有STEMI的患者符合入组条件。患者将被排除有HF史（功能性III–IV级），严重的瓣膜病，严重的肾脏疾病（4-5期），活动性感染，近期使用免疫抑制药物，活动性恶性肿瘤或慢性自身免疫/自体炎症疾病。我们将分别比较每个anakinra组和安慰剂组之间在入院与第14天之间C反应蛋白曲线下面积的差异。如果<0.025以调整多个比较，则P值将被认为是有意义的。入组后还将对患者进行长达12个月的随访，以评估心脏重塑（超声心动图），心脏功能（超声心动图）和主要的不良心血管预后（心血管死亡，MI，血运重建和新发HF）。

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