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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00994292
First received: October 13, 2009
Last updated: April 9, 2013
Last verified: June 2011
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Drug: YM150
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Astellas Pharma Inc:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Major and Clinically Relevant Non Major bleeding events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Enrollment: 1276
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994292

  Hide Study Locations
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, B1000
Brussels, Belgium, 1200
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, J6V 2H2
Montreal, Canada, H3G 1A4
St Jerome, Canada, J7Z 5T3
Colombia
Barranquilla, Colombia
Bogota, Colombia
Cartagena, Colombia
Floridablanca, Colombia
Czech Republic
Beroun, Czech Republic, 266 01
Brno, Czech Republic, 636 00
Brno, Czech Republic, 625 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, 500072
Hyderabaad, India, 500001
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, 135-720
Seoul, Korea, Republic of, 158-710
Mexico
Colonia Burocratas del Estado, Mexico, 78200
Guadalajara, Mexico, 44290
Guadalajara, Mexico, 44340
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, 020152
Bucuresti, Romania, 014461
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, 119620
Moscow, Russian Federation, 127644
Moscow, Russian Federation, 115093
Moscow, Russian Federation, 111539
Saratov, Russian Federation, 410054
Tomsk, Russian Federation, 643012
Tyumen, Russian Federation, 625026
Tyumen, Russian Federation, 625023
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, 61178
Kharkiv, Ukraine, 61002
Kyiv, Ukraine, 03152
Zaporizhzhya, Ukraine, 69000
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00994292     History of Changes
Other Study ID Numbers: 150-CL-201, 2008-005972-29
Study First Received: October 13, 2009
Last Updated: April 9, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Mexico: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Department of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Factor Xa
Anticoagulant
YM150
Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014