{"id":15910,"date":"2012-02-07T15:35:55","date_gmt":"2012-02-07T20:35:55","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=15910"},"modified":"2012-02-07T15:35:55","modified_gmt":"2012-02-07T20:35:55","slug":"bleeding-problems-continue-to-bedevil-mercks-novel-antiplatelet-agent-vorapaxar","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/02\/07\/bleeding-problems-continue-to-bedevil-mercks-novel-antiplatelet-agent-vorapaxar\/","title":{"rendered":"Bleeding Problems Continue to Bedevil Merck&#8217;s Novel Antiplatelet Agent Vorapaxar"},"content":{"rendered":"<p>In the large\u00a0TRA-2P study of more than 26,000 patients with \u00a0MI, ischemic stroke, or documented peripheral vascular disease,\u00a0the novel antiplatelet agent vorapaxar significantly reduced the primary endpoint of CV death, MI, stroke, or urgent coronary revascularization. But treatment resulted in a significant increase in bleeding, including intracranial hemorrhage.<\/p>\n<p>The fate of vorapaxar now appears to be uncertain, as the company said it will review data from the drug&#8217;s two large clinical trials with the investigators of the trials and external experts to inform the company&#8217;s next steps.<\/p>\n<p>The full results of the\u00a0<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT00526474?term=vorapaxar&amp;rank=5\">TRA-2P<\/a> (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) trial\u00a0are scheduled to\u00a0be presented in March at the American College of Cardiology meeting. Merck today released the top-line results in a\u00a0<a href=\"http:\/\/www.merck.com\/newsroom\/news-release-archive\/research-and-development\/2012_0207.html\">press release<\/a>.<\/p>\n<p><a href=\"http:\/\/cardiobrief.org\/2011\/11\/13\/tracer-novel-anticoagulant-vorapaxar-runs-into-trouble-in-acs\/\">TRACER<\/a>, the large ACS trial with vorapaxar, was terminated early last year due to similar safety concerns. As reported\u00a0<a title=\"Braunwald: Vorapaxar Problem Based on Intracranial Bleeding in Patients with History of Stroke\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/braunwald-vorapaxar-problem-based-on-intracranial-bleeding-in-patients-with-history-of-stroke\/\">here<\/a>\u00a0last year, at the same time TRACER was stopped, the TRA-2P trial was modified. TRA-2P investigator Eugene Braunwald said that\u00a0vorapaxar would be discontinued in patients who experienced a stroke prior to entry or during the trial because of an increase in intracranial hemorrhage in these patients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the large\u00a0TRA-2P study of more than 26,000 patients with \u00a0MI, ischemic stroke, or documented peripheral vascular disease,\u00a0the novel antiplatelet agent vorapaxar significantly reduced the primary endpoint of CV death, MI, stroke, or urgent coronary revascularization. But treatment resulted in a significant increase in bleeding, including intracranial hemorrhage. The fate of vorapaxar now appears to [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[668,655],"class_list":["post-15910","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-thrombin-receptor-antagonist","tag-vorapaxar"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15910","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=15910"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/15910\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=15910"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=15910"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=15910"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}