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

September 29, 2015 updated by: Astellas Pharma Europe B.V.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1276

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB
      • Corrientes, Argentina, W3400AMZ
      • Salta, Argentina, A4406CLA
      • Salta, Argentina, A4400AWG
  • Australia
      • Concord, Australia, 2139
      • Douglas, Australia, 4814
  • Belgium
      • Aalst, Belgium, B9300
      • Bonheiden, Belgium, B2820
      • Brussels, Belgium, 1200
      • Brussels, Belgium, B1000
      • Brussels, Belgium, B1070
      • Genk, Belgium, B3600
      • Leper, Belgium, 8900
      • Ottignies, Belgium, 1340
  • Brazil
      • Brasilia, Brazil, 70658-700
      • Porto Alegre, Brazil, 90610-000
      • Recife, Brazil, 52051-380
      • Salvador, Brazil, 41810-010
      • Sao Jose, Brazil, 88103-901
      • Sao Paulo, Brazil, 04012-180
      • Uberlandia, Brazil, 38400-368
  • Canada
      • Cambridge, Canada, N1R 6V6
      • Hamilton, Canada, L8L 2X2
      • Laval, Canada, H7M 3L9
      • Longueuil, Canada, J4M 2A5
      • Montreal, Canada, G1V 4G5
      • Montreal, Canada, H3G 1A4
      • Montreal, Canada, J6V 2H2
      • St Jerome, Canada, J7Z 5T3
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Cartagena, Colombia
      • Floridablanca, Colombia
  • Czech Republic
      • Beroun, Czech Republic, 266 01
      • Brno, Czech Republic, 625 00
      • Brno, Czech Republic, 636 00
      • Jihlava, Czech Republic, 586 33
      • Kladno, Czech Republic, 272 59
      • Liberec, Czech Republic, 460 63
      • Pardubice, Czech Republic, 532 03
      • Prague, Czech Republic, 10034
      • Sternberk, Czech Republic, 785 01
      • Vsetin, Czech Republic, 755 01
      • Zlin, Czech Republic, 762 75
  • Denmark
      • Copenhagen, Denmark, 2100
  • France
      • Paris Cedex 18, France, 75877
  • Germany
      • Bad Nauheim, Germany, 61231
      • Dresden, Germany, 101067
      • Freiburg, Germany
      • Kassel, Germany, 34121
      • Neuss, Germany, 41464
  • Hungary
      • Balatonfured, Hungary, 8230
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1096
      • Debrecen, Hungary, 4032
      • Miskolc, Hungary, 3526
      • Nyiregyhaza, Hungary, 4400
      • Szeged, Hungary, 6720
      • Szekesfehervar, Hungary, 8000
      • Zalaegerszeg, Hungary, 8900
  • India
      • Ahmedabad, India, 380015
      • Ahmedabad, India, 380014
      • Ahmedabad, India, 380 006
      • Hyderabaad, India, 500001
      • Hyderabaad, India, 500072
      • Mangalore, India, 575004
      • Nagpur, India, 440012
      • New Delhi, India, 110018
      • Tamil Nadu, India, 600037
      • Tirupati, India, 517507
  • Korea, Republic of
      • Busan, Korea, Republic of, 603-714
      • Gwangju, Korea, Republic of, 501-757
      • Gyeonggi-do, Korea, Republic of, 471-020
      • Inchon, Korea, Republic of, 405-760
      • Seoul, Korea, Republic of, 158-710
      • Seoul, Korea, Republic of, 135-720
  • Mexico
      • Colonia Burocratas del Estado, Mexico, 78200
      • Guadalajara, Mexico, 44340
      • Guadalajara, Mexico, 44290
      • Merida, Mexico, 97129
      • Morelia, Mexico, CP 58070
      • Zapopan, Mexico, 45040
  • Netherlands
      • Amsterdam, Netherlands, 1061 AE
      • Heerlen, Netherlands, 6419 PC
      • Helmond, Netherlands, 5707 HA
      • Hertogenbosch, Netherlands, 5211 NL
      • Leeuwarden, Netherlands, 8934 AD
      • Nijmegen, Netherlands, 6532 SZ
      • Oss, Netherlands, 5342 BT
  • Poland
      • Bialystok, Poland, 15-276
      • Elblag, Poland, 82-300
      • Gdansk, Poland, 80-952
      • Inowroclaw, Poland, 88-100
      • Krakow, Poland, 31-202
      • Przemysl, Poland, 37-700
  • Romania
      • Baia Mare, Romania, 430110
      • Braila, Romania, 810249
      • Bucuresti, Romania, 014461
      • Bucuresti, Romania, 020152
      • Craiova, Romania, 200642
      • Oradea, Romania, 410169
      • Targoviste, Romania, 130083
      • Targu Mures, Romania, 540136
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454136
      • Kemerovo, Russian Federation, 650002
      • Moscow, Russian Federation, 111539
      • Moscow, Russian Federation, 119620
      • Moscow, Russian Federation, 115093
      • Moscow, Russian Federation, 127644
      • Saratov, Russian Federation, 410054
      • Tomsk, Russian Federation, 643012
      • Tyumen, Russian Federation, 625023
      • Tyumen, Russian Federation, 625026
      • Yaroslavl, Russian Federation, 150062
  • Slovakia
      • Martin, Slovakia, 036 59
      • Nitra, Slovakia, 949 01
      • Rimavska Sobota, Slovakia, 979 01
      • Ruzomberok, Slovakia, 034 26
  • South Africa
      • George, South Africa, 6529
      • Johannesburg, South Africa, 2193
      • Kuilsriver, South Africa, 7580
      • Parow, South Africa, 7500
      • Pinelands, South Africa, 7405
      • Tongaat, South Africa, 4399
      • Umhlanga, South Africa, 4319
      • Western Cape, South Africa, 7130
      • Worcester, South Africa, 6850
  • Ukraine
      • Kharkiv, Ukraine, 61002
      • Kharkiv, Ukraine, 61178
      • Kyiv, Ukraine, 03152
      • Zaporizhzhya, Ukraine, 69000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Major and Clinically Relevant Non Major bleeding events
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-201
  • 2008-005972-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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