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首页> 外文期刊>Journal of thrombosis and thrombolysis >A randomized, placebo-controlled trial to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamics of a potent inhibitor of poly(ADP-ribose) polymerase (INO-1001) in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the TIMI 37 trial.
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A randomized, placebo-controlled trial to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamics of a potent inhibitor of poly(ADP-ribose) polymerase (INO-1001) in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the TIMI 37 trial.

机译：一项随机，安慰剂对照试验，评估强（ADP-核糖）聚合酶抑制剂（INO-1001）在ST抬高型心肌梗死患者中接受原发性经皮冠状动脉介入治疗的耐受性，安全性，药代动力学和药效学：结果TIMI 37试验。

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摘要

BACKGROUND: Reperfusion injury is a significant complication of the management of ST-elevation MI (STEMI). INO-1001 is a potent inhibitor of poly(ADP-ribose) polymerase (PARP), a mediator of oxidant-induced myocyte dysfunction during reperfusion. METHODS & RESULTS: We assessed the safety and pharmacokinetics of INO-1001 in a randomized, placebo-controlled, single-blind, dose-escalating trial in 40 patients with STEMI undergoing primary percutaneous coronary intervention within 24 h of onset. INO-1001 was well-tolerated. A trend toward more frequent transaminitis was observed with 800 mg. Plasma from INO1001-treated patients reduced in vitro PARP activity >90% at all doses. Serial C-reactive protein and IL-6 levels showed a trend toward blunting of inflammation with INO-1001. The apparent median terminal half-life (t(1/2)) of INO-1001 was 7.5 (25th, 75th: 5.9, 10.2) h. CONCLUSIONS: The results from this first trial of INO-1001 in STEMI support future investigation of INO-1001 as a novel treatment for reperfusion injury.
机译：背景：再灌注损伤是ST段抬高MI（STEMI）治疗的重要并发症。 INO-1001是聚（ADP-核糖）聚合酶（PARP）的有效抑制剂，聚（ADP-核糖）聚合酶（PARP）是再灌注过程中氧化剂诱导的肌细胞功能障碍的介体。方法与结果：我们在随机，安慰剂对照，单盲，剂量递增试验中，对40名STEMI患者在发病后24小时内接受初次经皮冠状动脉介入治疗的INO-1001的安全性和药代动力学进行了评估。 INO-1001的耐受性良好。服用800毫克时，观察到了更常见的氨氮炎的趋势。在所有剂量下，来自INO1001治疗患者的血浆均使体外PARP活性降低> 90％。连续的C反应蛋白和IL-6水平显示了使用INO-1001使炎症减弱的趋势。 INO-1001的表观终末半衰期（t（1/2））为7.5（25th，75th：5.9，10.2）h。结论：INO-1001在STEMI中的首次试验结果支持将来对INO-1001作为再灌注损伤的新疗法的研究。

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