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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00994292
First received: October 13, 2009
Last updated: April 9, 2013
Last verified: June 2011

October 13, 2009
April 9, 2013
September 2009
February 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00994292 on ClinicalTrials.gov Archive Site
Incidence of Major and Clinically Relevant Non Major bleeding events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Coronary Syndrome
  • Drug: YM150
    oral
  • Drug: Placebo
    oral
  • Experimental: 1. YM150 Dose V, twice daily
    Intervention: Drug: YM150
  • Experimental: 2. YM150 Dose W, once daily
    Intervention: Drug: YM150
  • Experimental: 3. YM150 Dose X, twice daily
    Intervention: Drug: YM150
  • Experimental: 4. YM150 Dose Y, once daily
    Intervention: Drug: YM150
  • Experimental: 5. YM150 Dose Y, twice daily
    Intervention: Drug: YM150
  • Experimental: 6. YM150 Dose Z, once daily
    Intervention: Drug: YM150
  • Placebo Comparator: 7. Placebo
    Intervention: Drug: Placebo
Steg PG, Mehta SR, Jukema JW, Lip GY, Gibson CM, Kovar F, Kala P, Garcia-Hernandez A, Renfurm RW, Granger CB; RUBY-1 Investigators. RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome. Eur Heart J. 2011 Oct;32(20):2541-54. Epub 2011 Aug 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1276
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Ukraine,   India,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa
 
NCT00994292
150-CL-201, 2008-005972-29
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP