Acute Coronary SyndromePhase 2RUBY-1NCT00994292
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
A Phase 2 study testing YM150 in people with Acute Coronary Syndrome, run by Astellas Pharma Europe B.V. at 131 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- YM150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,276 participants
- Where
- 131 sitesin 21 countries
- Study dates
- Sep 2009to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
131 sites in 21 countries.
131 sites in 21 countries
Czechia11 sites
Study site
Beroun, 266 01
Study site
Brno, 625 00
Study site
Brno, 636 00
Study site
Jihlava, 586 33
Study site
Kladno, 272 59
Study site
Liberec, 460 63
Study site
Pardubice, 532 03
Study site
Prague, 10034
Study site
Sternberk, 785 01
Study site
Vsetín, 755 01
Study site
Zlín, 762 75
Russia11 sites
Study site
Chelyabinsk, 454136
Study site
Kemerovo, 650002
Study site
Moscow, 111539
Study site
Moscow, 115093
Study site
Moscow, 119620
Study site
Moscow, 127644
Study site
Saratov, 410054
Study site
Tomsk, 643012
Study site
Tyumen, 625023
Study site
Tyumen, 625026
Study site
Yaroslavl, 150062
India10 sites
Study site
Ahmedabad, 380 006
Study site
Ahmedabad, 380014
Study site
Ahmedabad, 380015
Study site
Hyderabaad, 500001
Study site
Hyderabaad, 500072
Study site
Mangalore, 575004
Study site
Nagpur, 440012
Study site
New Delhi, 110018
Study site
Tamil Nadu, 600037
Study site
Tirupati, 517507
Hungary9 sites
Study site
Balatonfüred, 8230
Study site
Budapest, 1096
Study site
Budapest, 1122
Study site
Debrecen, 4032
Study site
Miskolc, 3526
Study site
Nyíregyháza, 4400
Study site
Szeged, 6720
Study site
Székesfehérvár, 8000
Study site
Zalaegerszeg, 8900
South Africa9 sites
Study site
George, 6529
Study site
Johannesburg, 2193
Study site
Kuilsriver, 7580
Study site
Parow, 7500
Study site
Pinelands, 7405
Study site
Tongaat, 4399
Study site
Umhlanga, 4319
Study site
Western Cape, 7130
Study site
Worcester, 6850
Belgium8 sites
Study site
Aalst, B9300
Study site
Bonheiden, B2820
Study site
Brussels, 1200
Study site
Brussels, B1000
Study site
Brussels, B1070
Study site
Genk, B3600
Study site
Leper, 8900
Study site
Ottignies, 1340
Canada8 sites
Study site
Cambridge, N1R 6V6
Study site
Hamilton, L8L 2X2
Study site
Laval, H7M 3L9
Study site
Longueuil, J4M 2A5
Study site
Montreal, G1V 4G5
Study site
Montreal, H3G 1A4
Study site
Montreal, J6V 2H2
Study site
Saint-Jérôme, J7Z 5T3
Romania8 sites
Study site
Baia Mare, 430110
Study site
Brăila, 810249
Study site
Bucharest, 014461
Study site
Bucharest, 020152
Study site
Craiova, 200642
Study site
Oradea, 410169
Study site
Targoviste, 130083
Study site
Târgu Mureş, 540136
Brazil7 sites
Study site
Brasília, 70658-700
Study site
Porto Alegre, 90610-000
Study site
Recife, 52051-380
Study site
Salvador, 41810-010
Study site
São José, 88103-901
Study site
São Paulo, 04012-180
Study site
Uberlândia, 38400-368
Netherlands7 sites
Study site
's-Hertogenbosch, 5211 NL
Study site
Amsterdam, 1061 AE
Study site
Heerlen, 6419 PC
Study site
Helmond, 5707 HA
Study site
Leeuwarden, 8934 AD
Study site
Nijmegen, 6532 SZ
Study site
Oss, 5342 BT
Mexico6 sites
Study site
Burócratas del Estado, 78200
Study site
Guadalajara, 44290
Study site
Guadalajara, 44340
Study site
Mérida, 97129
Study site
Morelia, CP 58070
Study site
Zapopan, 45040
Poland6 sites
Study site
Bialystok, 15-276
Study site
Elblag, 82-300
Study site
Gdansk, 80-952
Study site
Inowrocław, 88-100
Study site
Krakow, 31-202
Study site
Przemyśl, 37-700
South Korea6 sites
Study site
Busan, 603-714
Study site
Gwangju, 501-757
Study site
Gyeonggi-do, 471-020
Study site
Inchon, 405-760
Study site
Seoul, 135-720
Study site
Seoul, 158-710
Germany5 sites
Study site
Bad Nauheim, 61231
Study site
Dresden, 101067
Study site
Freiburg im Breisgau
Study site
Kassel, 34121
Study site
Neuss, 41464
Argentina4 sites
Study site
Buenos Aires, C1280AEB
Study site
Corrientes, W3400AMZ
Study site
Salta, A4400AWG
Study site
Salta, A4406CLA
Colombia4 sites
Study site
Barranquilla
Study site
Bogotá
Study site
Cartagena
Study site
Floridablanca
Slovakia4 sites
Study site
Martin, 036 59
Study site
Nitra, 949 01
Study site
Rimavská Sobota, 979 01
Study site
Ružomberok, 034 26
Ukraine4 sites
Study site
Kharkiv, 61002
Study site
Kharkiv, 61178
Study site
Kyiv, 03152
Study site
Zaporizhzhya, 69000
About this study
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
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- YM150, Placebo
- Keywords
- Factor Xa, Anticoagulant, YM150, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM150Drug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1. YM150 Dose V, twice daily | Experimental | Not described Receives: Drug: YM150 |
| 2. YM150 Dose W, once daily | Experimental | Not described Receives: Drug: YM150 |
| 3. YM150 Dose X, twice daily | Experimental | Not described Receives: Drug: YM150 |
| 4. YM150 Dose Y, once daily | Experimental | Not described Receives: Drug: YM150 |
| 5. YM150 Dose Y, twice daily | Experimental | Not described Receives: Drug: YM150 |
| 6. YM150 Dose Z, once daily | Experimental | Not described Receives: Drug: YM150 |
| 7. Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition
Measured: 6 Months
Secondary outcomes (1)
Incidence of Major and Clinically Relevant Non Major bleeding events
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994292
- Sponsor's protocol ID
- 150-CL-201
- Other IDs
- 2008-005972-29, 2008
- Acronym
- RUBY-1
- Status last verified
- Sep 2015
- First submitted
- 13 Oct 2009
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21878434
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00994292
- Acronym / sponsor ID
- RUBY-1 / 150-CL-201
- Conditions
- Acute Coronary Syndrome
- Keywords
- Factor Xa, Anticoagulant, YM150, Acute Coronary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,276 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1. YM150 Dose V, twice daily | Experimental | Drug: YM150 |
| 2. YM150 Dose W, once daily | Experimental | Drug: YM150 |
| 3. YM150 Dose X, twice daily | Experimental | Drug: YM150 |
| 4. YM150 Dose Y, once daily | Experimental | Drug: YM150 |
| 5. YM150 Dose Y, twice daily | Experimental | Drug: YM150 |
| 6. YM150 Dose Z, once daily | Experimental | Drug: YM150 |
| 7. Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YM150oral | Drug | 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 |
| Placebooral | Drug | 7. Placebo |
Primary outcome
Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition
Time frame: 6 Months
1 secondary outcome
Incidence of Major and Clinically Relevant Non Major bleeding events
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Derived from this study: PubMed 21878434Steg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study director
Astellas Pharma Europe B.V.
131 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM150 in people with Acute Coronary Syndrome, run by Astellas Pharma Europe B.V. at 131 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 131 sites in Czechia, Russia, India, Hungary, South Africa and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.