Kenneth Mahaffey 美国杜克大学医学院

    <International Circulation>:  Could you explain the TRACER trial design and results for us?

  《国际循环》：您能为我们介绍一下TRACER研究设计和结果吗？
 
    Prof. Mahaffey:  TRACER was a trial to evaluate a novel drug called Vorapaxar， which blocks thrombin activation of platelets， one of the most potent activators of platelets.  The TRACER trial was designed to enroll a high-risk patient population with acute coronary syndromes and randomize them to Vorapaxar or placebo， then follow each of them for at least one year to evaluate safety and efficacy with predefined primary and secondary endpoints.  The results showed that for the primary endpoint， it was a quintuple composite of cardiovascular death， myocardial infarction， stroke， or urgent hospitalization for ischemia， that there was a 9-10% relative reduction in the hazard for that outcome for Vorapaxar when compared to placebo.  It did not reach statistical significance with a p-value of 0.072.  This demonstrates a more modest treatment effect than we anticipated when we were planning the trial based on earlier phase II clinical studies of Vorapaxar.  Regarding safety there was more bleeding with Vorapaxar， more severe bleeding， more TIMI major bleeding， all statistically significantly increased， with a 2% increase in moderate to severe bleeding.  There was a trend towards more fatal hemorrhages， which was not statistically significant， and there was as statistically significant increase in intracranial hemorrhage.  

    Mahaffey教授：TRACER研究是用于评估一种新的药物Vorapaxar，该药物阻止血小板凝血酶激活，凝血酶是血小板最有力的活化因子。TRACER研究纳入急性冠脉综合征高风险患者人群，随机分为Vorapaxar组和安慰剂组，然后随访至少一年，根据预定的主要终点和次要终点评估药物安全性和有效性。
    结果表明，与安慰剂相比，Vorapaxar组主要终点的风险降低9-10%。主要终点是包括心血管死亡、心肌梗死、中风或因缺血而紧急住院的复合终点。差异没有统计学意义，P值为0.072。在我们计划该研究时，我们根据之前的VorapaxarII期临床研究结果预期了临床疗效。而研究数据表明，这个治疗效果比预期的温和。在安全性方面，Vorapaxar组出血患者更多，出血更严重，严重TIMI出血更多，都呈显著性增加，中度至严重出血增加2％。有更致命性出血的趋势，差异没有统计学意义。颅内出血的增加有统计学差异。