在稳定冠状动脉疾病患者中,对抗剂控制的因子IXa活性调节的1b期随机研究
Mark Y Chan1, Mauricio G Cohen, Christopher K Dyke
1Duke Clinical Research Institute, 2400 Pratt St, Terrace Level Room 0311, Durham, NC 27705, USA.
Circulation
|May 29, 2008
概括
REG1是一种新型的RNA胺酶疗法,在接受抗血小板治疗的冠状动脉疾病患者中有效抑制IXa因子的活性. 药物抗毒剂系统表现出可预测的抗凝作用和快速逆转,没有重大出血事件.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
- 血栓形成研究研究
背景情况:
- 针对正在接受抗血小板治疗的稳定冠状动脉疾病 (CAD) 患者研究新型抗凝血剂.
- 评估选择性因子IXa抑制与血小板导向治疗相结合的疗效和安全性.
研究的目的:
- 为了评估REG1的安全性,耐受性和药学动力学,一个向因子IXa的RNA吸收酶药物抗剂系统.
- 确定REG1在CAD患者中剂量依赖的抗凝剂作用和逆转能力.
主要方法:
- 一项随机,双盲,安慰剂控制的研究,涉及50名接受阿司匹林和/或克洛皮多格雷尔治疗的CAD患者.
- 用REG1 (RB006药物,RB007抗毒剂) 在四个不断升级的剂量级别上使用.
- 激活的部分血栓形成时间 (aPTT) 和不良事件的监测.
主要成果:
- RB006显示了aPTT的剂量依赖性增加,表明有效的因子IXa抑制 (P<0.0001).
- 在1分钟内,RB007迅速将aPTT逆转到基线,在7天内没有观察到反弹效应.
- 没有报告严重出血或严重不良事件,这表明耐受性良好.
结论:
- REG1代表了第一个成功抑制和恢复抗血小板治疗的CAD患者因子IXa活性的RNA吸收酶药物-抗剂对.
- 可预测的药理动力学效应和初步的安全性资料支持在接受选择性再血管化治疗的患者中进一步调查.
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