Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes (RUBY-1)


Tracking Information

Start Date  ICMJESeptember 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)		Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00994292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 13, 2009)		Incidence of Major and Clinically Relevant Non Major bleeding events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
Official Title  ICMJEA 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
Brief Summary

The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEAcute Coronary Syndrome
Intervention  ICMJE
  • Drug: YM150
    oral
  • Drug: Placebo
    oral
Study Arms / Comparison Groups
  • 1. YM150 Dose V, twice daily: Experimental
    Intervention: Drug: YM150
  • 2. YM150 Dose W, once daily: Experimental
    Intervention: Drug: YM150
  • 3. YM150 Dose X, twice daily: Experimental
    Intervention: Drug: YM150
  • 4. YM150 Dose Y, once daily: Experimental
    Intervention: Drug: YM150
  • 5. YM150 Dose Y, twice daily: Experimental
    Intervention: Drug: YM150
  • 6. YM150 Dose Z, once daily: Experimental
    Intervention: Drug: YM150
  • 7. Placebo: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1264
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • has a diagnosis of STE-ACS, NSTE-ACS as index event according to accepted guidelines such as the ESC or AHA guidelines
  • has elevated cardiac biomarkers

Exclusion Criteria:

  • is planned for myocardial revascularization (e.g., Coronary Artery Bypass Graft (CABG) or elective or staged PCI) or any other invasive procedure with increased risk for bleeding (i.e. elective surgical procedures) within 60 days after randomization
  • has had recent stroke or TIA ≤ 12 months prior to index event
  • has persistent BP of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher at baseline with or without medication
  • has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
  • has participated in any YM150 clinical trials
  • requires ongoing parenteral or oral anticoagulant therapy
  • has active bleeding or is in the opinion of the investigator at high risk of bleeding during the study
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Medical Clinical Development Department+ 31 (0)71 54 55745contact@nl.astellas.com
Location Countries  ICMJEArgentina,   Australia,   Belgium,   Brazil,   Canada,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   India,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00994292
Responsible PartyDisclosure Office Europe, Astellas Pharma Europe BV
Study ID Numbers  ICMJE150-CL-201, EudraCt 2008-005972-29
Study Sponsor  ICMJEAstellas Pharma Inc
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Use Central ContactAstellas Pharma Europe BV
Information Provided ByAstellas Pharma Inc