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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00994292




Registration number
NCT00994292
Ethics application status
Date submitted
13/10/2009
Date registered
14/10/2009
Date last updated
19/10/2015

Titles & IDs
Public title
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
Scientific 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
Secondary ID [1] 0 0
2008-005972-29
Secondary ID [2] 0 0
150-CL-201
Universal Trial Number (UTN)
Trial acronym
RUBY-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YM150
Treatment: Drugs - Placebo

Experimental: 1. YM150 Dose V, twice daily -

Experimental: 2. YM150 Dose W, once daily -

Experimental: 3. YM150 Dose X, twice daily -

Experimental: 4. YM150 Dose Y, once daily -

Experimental: 5. YM150 Dose Y, twice daily -

Experimental: 6. YM150 Dose Z, once daily -

Placebo comparator: 7. Placebo -


Treatment: Drugs: YM150
oral

Treatment: Drugs: Placebo
oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Incidence of Major and Clinically Relevant Non Major bleeding events
Timepoint [1] 0 0
30 Days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
1276
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Douglas
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Ciudad Autonoma de Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Corrientes
Country [3] 0 0
Argentina
State/province [3] 0 0
Salta
Country [4] 0 0
Belgium
State/province [4] 0 0
Aalst
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Belgium
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Bonheiden
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Belgium
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Brussels
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Belgium
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Genk
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Belgium
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Leper
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Belgium
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Ottignies
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Brazil
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Brasilia
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Salvador
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Brazil
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Sao Jose
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Brazil
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Sao Paulo
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Brazil
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Uberlandia
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Canada
State/province [17] 0 0
Cambridge
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Canada
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Hamilton
Country [19] 0 0
Canada
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Laval
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Canada
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Longueuil
Country [21] 0 0
Canada
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Montreal
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Canada
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St Jerome
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Cartagena
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Colombia
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Floridablanca
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Czech Republic
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Beroun
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Czech Republic
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Brno
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Czech Republic
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Jihlava
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Czech Republic
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Kladno
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Czech Republic
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Liberec
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Czech Republic
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Pardubice
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Czech Republic
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Prague
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Czech Republic
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Sternberk
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Czech Republic
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Vsetin
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Czech Republic
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Zlin
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Denmark
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Copenhagen
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France
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Paris Cedex 18
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Germany
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Germany
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Dresden
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Kassel
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Neuss
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Balatonfured
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Budapest
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Debrecen
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Miskolc
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Hungary
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Nyiregyhaza
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Szeged
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Hungary
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Szekesfehervar
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Hungary
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Zalaegerszeg
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India
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Ahmedabad
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India
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Hyderabaad
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India
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Mangalore
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India
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Nagpur
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India
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Tirupati
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Busan
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Gwangju
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Inchon
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Romania
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Targoviste
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Romania
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Targu Mures
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Saratov
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Russian Federation
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Yaroslavl
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Slovakia
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Martin
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Nitra
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Slovakia
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South Africa
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George
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South Africa
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Johannesburg
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South Africa
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Kuilsriver
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South Africa
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Parow
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South Africa
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Pinelands
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South Africa
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Tongaat
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South Africa
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Umhlanga
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South Africa
State/province [107] 0 0
Western Cape
Country [108] 0 0
South Africa
State/province [108] 0 0
Worcester
Country [109] 0 0
Ukraine
State/province [109] 0 0
Kharkiv
Country [110] 0 0
Ukraine
State/province [110] 0 0
Kyiv
Country [111] 0 0
Ukraine
State/province [111] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Europe B.V.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00994292
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Use Central Contact
Address 0 0
Astellas Pharma Europe B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00994292