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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM150
Placebo
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Factor Xa, Anticoagulant, YM150, Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1. YM150 Dose V, twice daily

2. YM150 Dose W, once daily

3. YM150 Dose X, twice daily

4. YM150 Dose Y, once daily

5. YM150 Dose Y, twice daily

6. YM150 Dose Z, once daily

7. Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition

Secondary Outcome Measures

Incidence of Major and Clinically Relevant Non Major bleeding events

Full Information

First Posted
October 13, 2009
Last Updated
September 29, 2015
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00994292
Brief Title
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
Acronym
RUBY-1
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Factor Xa, Anticoagulant, YM150, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. YM150 Dose V, twice daily
Arm Type
Experimental
Arm Title
2. YM150 Dose W, once daily
Arm Type
Experimental
Arm Title
3. YM150 Dose X, twice daily
Arm Type
Experimental
Arm Title
4. YM150 Dose Y, once daily
Arm Type
Experimental
Arm Title
5. YM150 Dose Y, twice daily
Arm Type
Experimental
Arm Title
6. YM150 Dose Z, once daily
Arm Type
Experimental
Arm Title
7. Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of Major and Clinically Relevant Non Major bleeding events
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
City
Salta
ZIP/Postal Code
A4400AWG
Country
Argentina
City
Salta
ZIP/Postal Code
A4406CLA
Country
Argentina
City
Concord
ZIP/Postal Code
2139
Country
Australia
City
Douglas
ZIP/Postal Code
4814
Country
Australia
City
Aalst
ZIP/Postal Code
B9300
Country
Belgium
City
Bonheiden
ZIP/Postal Code
B2820
Country
Belgium
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
City
Brussels
ZIP/Postal Code
B1000
Country
Belgium
City
Brussels
ZIP/Postal Code
B1070
Country
Belgium
City
Genk
ZIP/Postal Code
B3600
Country
Belgium
City
Leper
ZIP/Postal Code
8900
Country
Belgium
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
City
Brasilia
ZIP/Postal Code
70658-700
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
City
Recife
ZIP/Postal Code
52051-380
Country
Brazil
City
Salvador
ZIP/Postal Code
41810-010
Country
Brazil
City
Sao Jose
ZIP/Postal Code
88103-901
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04012-180
Country
Brazil
City
Uberlandia
ZIP/Postal Code
38400-368
Country
Brazil
City
Cambridge
ZIP/Postal Code
N1R 6V6
Country
Canada
City
Hamilton
ZIP/Postal Code
L8L 2X2
Country
Canada
City
Laval
ZIP/Postal Code
H7M 3L9
Country
Canada
City
Longueuil
ZIP/Postal Code
J4M 2A5
Country
Canada
City
Montreal
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Montreal
ZIP/Postal Code
H3G 1A4
Country
Canada
City
Montreal
ZIP/Postal Code
J6V 2H2
Country
Canada
City
St Jerome
ZIP/Postal Code
J7Z 5T3
Country
Canada
City
Barranquilla
Country
Colombia
City
Bogota
Country
Colombia
City
Cartagena
Country
Colombia
City
Floridablanca
Country
Colombia
City
Beroun
ZIP/Postal Code
266 01
Country
Czech Republic
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
City
Brno
ZIP/Postal Code
636 00
Country
Czech Republic
City
Jihlava
ZIP/Postal Code
586 33
Country
Czech Republic
City
Kladno
ZIP/Postal Code
272 59
Country
Czech Republic
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
City
Prague
ZIP/Postal Code
10034
Country
Czech Republic
City
Sternberk
ZIP/Postal Code
785 01
Country
Czech Republic
City
Vsetin
ZIP/Postal Code
755 01
Country
Czech Republic
City
Zlin
ZIP/Postal Code
762 75
Country
Czech Republic
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
City
Dresden
ZIP/Postal Code
101067
Country
Germany
City
Freiburg
Country
Germany
City
Kassel
ZIP/Postal Code
34121
Country
Germany
City
Neuss
ZIP/Postal Code
41464
Country
Germany
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
City
Ahmedabad
ZIP/Postal Code
380 006
Country
India
City
Ahmedabad
ZIP/Postal Code
380014
Country
India
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
City
Hyderabaad
ZIP/Postal Code
500001
Country
India
City
Hyderabaad
ZIP/Postal Code
500072
Country
India
City
Mangalore
ZIP/Postal Code
575004
Country
India
City
Nagpur
ZIP/Postal Code
440012
Country
India
City
New Delhi
ZIP/Postal Code
110018
Country
India
City
Tamil Nadu
ZIP/Postal Code
600037
Country
India
City
Tirupati
ZIP/Postal Code
517507
Country
India
City
Busan
ZIP/Postal Code
603-714
Country
Korea, Republic of
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
471-020
Country
Korea, Republic of
City
Inchon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
City
Colonia Burocratas del Estado
ZIP/Postal Code
78200
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44290
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
City
Merida
ZIP/Postal Code
97129
Country
Mexico
City
Morelia
ZIP/Postal Code
CP 58070
Country
Mexico
City
Zapopan
ZIP/Postal Code
45040
Country
Mexico
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
City
Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
City
Oss
ZIP/Postal Code
5342 BT
Country
Netherlands
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Inowroclaw
ZIP/Postal Code
88-100
Country
Poland
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
City
Przemysl
ZIP/Postal Code
37-700
Country
Poland
City
Baia Mare
ZIP/Postal Code
430110
Country
Romania
City
Braila
ZIP/Postal Code
810249
Country
Romania
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
City
Bucuresti
ZIP/Postal Code
020152
Country
Romania
City
Craiova
ZIP/Postal Code
200642
Country
Romania
City
Oradea
ZIP/Postal Code
410169
Country
Romania
City
Targoviste
ZIP/Postal Code
130083
Country
Romania
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119620
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
643012
Country
Russian Federation
City
Tyumen
ZIP/Postal Code
625023
Country
Russian Federation
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
City
Ruzomberok
ZIP/Postal Code
034 26
Country
Slovakia
City
George
ZIP/Postal Code
6529
Country
South Africa
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
City
Kuilsriver
ZIP/Postal Code
7580
Country
South Africa
City
Parow
ZIP/Postal Code
7500
Country
South Africa
City
Pinelands
ZIP/Postal Code
7405
Country
South Africa
City
Tongaat
ZIP/Postal Code
4399
Country
South Africa
City
Umhlanga
ZIP/Postal Code
4319
Country
South Africa
City
Western Cape
ZIP/Postal Code
7130
Country
South Africa
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61178
Country
Ukraine
City
Kyiv
ZIP/Postal Code
03152
Country
Ukraine
City
Zaporizhzhya
ZIP/Postal Code
69000
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
21878434
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=570
Description
Link to Results on JAPIC

Learn more about this trial

Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes

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