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ARTICLE | Clinical News

Xarelto: Ph II GEMINI-ACS-1 data

March 31, 2017 6:31 PM UTC

The double-blind, international Phase II GEMINI-ACS-1 trial in 3,037 patients with ACS showed that twice-daily 2.5 mg oral Xarelto plus clopidogrel or Brilinta ticagrelor led to no significant difference in the rate of TIMI clinically significant bleeding vs. aspirin plus clopidogrel or Brilinta (5.3% vs. 4.9%, p=0.58). There was also no significant difference between the Xarelto and aspirin arms in the rate of the composite endpoint of cardiovascular death, myocardial infarction (MI), stroke or stent thrombosis (5% vs. 4.7%, p=0.73). Data were published in The Lancet and presented at the American College of Cardiology meeting in Washington, D.C. GEMINI-ACS-1 is part of the EXPLORER clinical research program evaluating Xarelto in a target population of >275,000 patients. The program includes 10 indication-seeking and label expansion studies beyond the 6 indications for which the drug is approved in the U.S...

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