<International Circulation>:The session on Late-breaking Clinical Trials is always a highlight of the meeting. You have just presented the results of the TRACER trial. Can you give us a brief introduction of this trial and what do you think about the negative results for the primary endpoint?
  《国际循环》：关于最新临床试验的峰会一直是本次会议的一个亮点。您刚刚报告了TRACER试验的研究结果。您能简要为我们介绍一下该试验吗？您怎么看待主要终点的阴性结果？
    Prof.Harrington:The TRACER trial is a late-breaking clinical trial that will actually be presented by one of my colleagues， Dr Ken Mahaffey， later on. I had the opportunity to present the results for the first time to the press today. In that study， we presented for the first time， results of a trial comparing a novel platelet inhibitor， vorapaxar， against placebo on top of standard care in a group of patients with acute coronary syndromes. As you noted， we did not achieve statistical significance on the primary endpoint (the primary endpoint being a five component composite) but we did note a reduction in the predefined secondary composite of CV death， myocardial infarction and stroke， largely driven by an effect on myocardial infarction. How do we as investigators interpret that? By the conservative rules of the way we set the trial up， we have to do just as you said – we have to say that we did not achieve statistical significance so anything beyond that primary endpoint becomes hypothesis-generating despite being predefined. Nonetheless， I think many of us look at the data and say， this makes sense; it fits with the biology that we believe that an antiplatelet agent might reduce myocardial infarction. It is very consistent in myocardial infarction. So we are actually optimistic despite being disappointed that the overall trial did not achieve its primary endpoint. We are also disappointed to see a much higher rate of bleeding than we had anticipated based on the phase II data. One needs to take the results in that context as well; that there was a large increased risk of bleeding including some severe bleeding (intracranial hemorrhage). Finally I would like to say that the TRACER trial involved a group of hospitals in China and we were very pleased to work with our Chinese colleagues who did an outstanding job of participating in the TRACER trial. We look forward to specifically sharing the results of TRACER with our colleagues from China. 
    Harrington教授: TRACER试验稍后将由我的一位同事Dr Ken Mahaffey汇报。今天我有机会向新闻界第一次报告其结果。在本项研究中，我们首次报道，一个新的血小板抑制剂vorapaxar和安慰剂在急性冠脉综合征治疗中的对比试验。正如你提到的，我们并没有得到有统计学意义的主要终点（主要终点须满足五个条件），但是我们也注意到心血管疾病死亡、心梗和中风等大多数继发于心梗成的次要复合终点的减少。我们如何按照研究者诠释的那样做呢？通过我们制定的试验的保守的规则，我们不得不如我们所说的那样做-我们不得不说我们并没有得到有统计学意义的结果因此任何在主要终点之外的理论都成为了假设-如之前定义的那般。尽管如此，我认为我们中许多人观察该资料并且会说，这是由意义的；它符合我们一直信奉的生物学规律，即抗血小板药物可能减少心肌梗死的发生。 这是人们在心肌梗死方面一直坚持的信条。因此我们实际上是非常乐观的，尽管对试验未能达到主要终点而感到失望。基于II期临床试验的数据，我们还对看到的比之前我们预期的高得多的出血风险感到失望。将结果结合具体情况来考虑也是需要的；出血的风险非常大甚至包括一些严重的出血（颅内出血）。最后我想说TRACER试验也有中国医院的参与，我们很高兴同中国同事一起工作，他们在该试验中表现十分出色。我们特别希望同中国同事一起分享TRACER的成果。

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