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. )

Study Description

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


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

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

Primary Outcome Measures :

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 :

Incidence of Major and Clinically Relevant Non Major bleeding events [ Time Frame: 30 Days ]

Eligibility Criteria

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

Contacts and Locations

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.

More Information

Additional Information:

Link to Results on JAPIC This link exits the ClinicalTrials.gov site

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 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

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