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

NCT00994292 | Completed Phase 2 DMC

• 2 other identifiers: 150-CL-2012008-005972-29
• Study Type: interventional
• Target: 1,276
• Locations: 21 countries
• Sites: 131

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.

Conditions

Acute Coronary Syndrome

Keywords

Factor Xa; Anticoagulant; YM150; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

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

  6 Months

Secondary Outcomes (1)

• Incidence of Major and Clinically Relevant Non Major bleeding events

  30 Days

Study Arms (7)

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

Interventions

YM150 DRUG

oral

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

Placebo DRUG

oral

7. Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (131)

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Buenos Aires, C1280AEB, Argentina

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Corrientes, W3400AMZ, Argentina

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Salta, A4400AWG, Argentina

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Salta, A4406CLA, Argentina

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Concord, 2139, Australia

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Douglas, 4814, Australia

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Aalst, B9300, Belgium

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Bonheiden, B2820, Belgium

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Brussels, 1200, Belgium

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Brussels, B1000, Belgium

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Brussels, B1070, Belgium

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Genk, B3600, Belgium

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Leper, 8900, Belgium

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Ottignies, 1340, Belgium

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Brasília, 70658-700, Brazil

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Porto Alegre, 90610-000, Brazil

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Recife, 52051-380, Brazil

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Salvador, 41810-010, Brazil

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São José, 88103-901, Brazil

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São Paulo, 04012-180, Brazil

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Uberlândia, 38400-368, Brazil

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Cambridge, N1R 6V6, Canada

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Hamilton, L8L 2X2, Canada

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Laval, H7M 3L9, Canada

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Longueuil, J4M 2A5, Canada

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Montreal, G1V 4G5, Canada

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Montreal, H3G 1A4, Canada

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Montreal, J6V 2H2, Canada

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Saint-Jérôme, J7Z 5T3, Canada

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Barranquilla, Colombia

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Bogotá, Colombia

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Cartagena, Colombia

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Floridablanca, Colombia

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Beroun, 266 01, Czechia

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Brno, 625 00, Czechia

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Brno, 636 00, Czechia

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Jihlava, 586 33, Czechia

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Kladno, 272 59, Czechia

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Liberec, 460 63, Czechia

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Pardubice, 532 03, Czechia

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Prague, 10034, Czechia

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Sternberk, 785 01, Czechia

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Vsetín, 755 01, Czechia

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Zlín, 762 75, Czechia

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Copenhagen, 2100, Denmark

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Paris, 75877, France

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Bad Nauheim, 61231, Germany

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Dresden, 101067, Germany

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Freiburg im Breisgau, Germany

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Kassel, 34121, Germany

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Neuss, 41464, Germany

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Balatonfüred, 8230, Hungary

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Budapest, 1096, Hungary

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Budapest, 1122, Hungary

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Debrecen, 4032, Hungary

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Miskolc, 3526, Hungary

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Nyíregyháza, 4400, Hungary

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Szeged, 6720, Hungary

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Székesfehérvár, 8000, Hungary

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Zalaegerszeg, 8900, Hungary

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Ahmedabad, 380 006, India

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Ahmedabad, 380014, India

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Ahmedabad, 380015, India

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Hyderabaad, 500001, India

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Hyderabaad, 500072, India

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Mangalore, 575004, India

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Nagpur, 440012, India

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New Delhi, 110018, India

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Tamil Nadu, 600037, India

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Tirupati, 517507, India

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Burócratas del Estado, 78200, Mexico

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Guadalajara, 44290, Mexico

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Guadalajara, 44340, Mexico

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Mérida, 97129, Mexico

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Morelia, CP 58070, Mexico

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Zapopan, 45040, Mexico

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's-Hertogenbosch, 5211 NL, Netherlands

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Amsterdam, 1061 AE, Netherlands

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Heerlen, 6419 PC, Netherlands

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Helmond, 5707 HA, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Oss, 5342 BT, Netherlands

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Bialystok, 15-276, Poland

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Elblag, 82-300, Poland

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Gdansk, 80-952, Poland

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Inowrocław, 88-100, Poland

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Krakow, 31-202, Poland

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Przemyśl, 37-700, Poland

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Baia Mare, 430110, Romania

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Brăila, 810249, Romania

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Bucharest, 014461, Romania

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Bucharest, 020152, Romania

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Craiova, 200642, Romania

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Oradea, 410169, Romania

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Târgovişte, 130083, Romania

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Târgu Mureş, 540136, Romania

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Chelyabinsk, 454136, Russia

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Kemerovo, 650002, Russia

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Moscow, 111539, Russia

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Moscow, 115093, Russia

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Moscow, 119620, Russia

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Moscow, 127644, Russia

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Saratov, 410054, Russia

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Tomsk, 643012, Russia

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Tyumen, 625023, Russia

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Tyumen, 625026, Russia

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Yaroslavl, 150062, Russia

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Martin, 036 59, Slovakia

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Nitra, 949 01, Slovakia

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Rimavská Sobota, 979 01, Slovakia

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Ružomberok, 034 26, Slovakia

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George, 6529, South Africa

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Johannesburg, 2193, South Africa

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Kuilsriver, 7580, South Africa

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Parow, 7500, South Africa

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Pinelands, 7405, South Africa

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Tongaat, 4399, South Africa

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Umhlanga, 4319, South Africa

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Western Cape, 7130, South Africa

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Worcester, 6850, South Africa

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Busan, 603-714, South Korea

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Gwangju, 501-757, South Korea

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Gyeonggi-do, 471-020, South Korea

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Inchon, 405-760, South Korea

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Seoul, 135-720, South Korea

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Seoul, 158-710, South Korea

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Kharkiv, 61002, Ukraine

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Kharkiv, 61178, Ukraine

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Kyiv, 03152, Ukraine

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Zaporizhzhya, 69000, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 21878434 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 19, 2015

Record last verified: 2015-09

Locations

ZA (9); DK (1); NL (7); IN (10); CA (8); RU (11); RO (8); ME (6); FR (1); CZ (11); CO (4); BE (8); UA (4); AR (4); KR (6); BR (7); HU (9); PL (6); AU (2); DE (5); SL (4)