Study of YM150 for prevention of IVE in patients with ACS RUBY-1 Study

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo Controlled Multi-Center and Parallel Group Study of the Safety, Tolerability and Efficacy of YM150 in combination with Standard Treatment in Secondary Prevention of Ischemic Vascular Events in Subjects with Acute Coronary Syndromes. The RUBY-1 study

• IRAS ID

  25524

• Contact name

  Gregory Lip

• Sponsor organisation

  Astellas Pharma Europe R&D

• Eudract number

  2008-005972-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this research study is to determine the safety and effectiveness of an investigational drug called YM150 for treating patients with Acute Coronary Syndrome or ACS. Acute coronary syndrome is a serious condition that causes sudden chest pain and other symptoms that happen because the heart does not get enough blood. YM150 has been designed to prevent further ischemic events from occurring in the future when given in combination with the current standard therapy for ACS. Patients will be randomised to receive one of seven different doses of YM150 or placebo in addition to their regular oral treatment to thin the blood (Aspirin or Clopidogrel or both). The information collected in this study will be analysed to find out at what strengths and doses of YM150 are safe and effective in addition to the standard treatment with aspirin, with or without Clopidogrel. As the study is double blind neither the doctor or patient will know what treatment they are receiving. Approximately 1264 patients will take part in the study from centres all over Europe, Latin America, South East Asia, etc. In the UK, approximately 42 patients will take part in the study. The total duration of the study is approximately 30 weeks during which patients will attend regular follow up visits. Study procedures will include complete physical and body skin examination, vital signs including weight and height, blood and urine sampling, pregnancy test, concomitant medications, ECG and adverse event reporting. An independent data monitoring committee Board (DSMB) will monitor the safety on a regular basis during the study to ensure timely recognition of previously unknown risks to patients.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/101

• Date of REC Opinion

  20 Jan 2010

• REC opinion

  Further Information Favourable Opinion