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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 131 Study Locations

Sponsors and Collaborators

Astellas Pharma Europe B.V.

Investigators

Study Director:	Use Central Contact	Astellas Pharma Europe B.V.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Link to Results on JAPIC 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1093/eurheartj/ehr334. Epub 2011 Aug 30.

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
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