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
|
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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
|
- Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition [ Time Frame: 6 Months ]
- Incidence of Major and Clinically Relevant Non Major bleeding events [ Time Frame: 30 Days ]

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

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

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 |