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

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ClinicalTrials.gov Identifier: NCT00994292
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: YM150 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : September 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: 1. YM150 Dose V, twice daily Drug: YM150
oral

Experimental: 2. YM150 Dose W, once daily Drug: YM150
oral

Experimental: 3. YM150 Dose X, twice daily Drug: YM150
oral

Experimental: 4. YM150 Dose Y, once daily Drug: YM150
oral

Experimental: 5. YM150 Dose Y, twice daily Drug: YM150
oral

Experimental: 6. YM150 Dose Z, once daily Drug: YM150
oral

Placebo Comparator: 7. Placebo Drug: Placebo
oral




Primary Outcome Measures :
  1. Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Incidence of Major and Clinically Relevant Non Major bleeding events [ Time Frame: 30 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994292


  Show 131 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT00994292     History of Changes
Other Study ID Numbers: 150-CL-201
2008-005972-29 ( EudraCT Number )
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: September 2015

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Factor Xa
Anticoagulant
YM150
Acute Coronary Syndrome

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Darexaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants