Clinical trial NCT00994292: Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Factor Xa
Anticoagulant
YM150
Acute Coronary Syndrome
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 1276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition
timeFrame: 6 Months
Secondary outcomes:
measure: Incidence of Major and Clinically Relevant Non Major bleeding events
timeFrame: 30 Days
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
city: Corrientes
country: Argentina
city: Salta
country: Argentina
city: Salta
country: Argentina
city: Concord
country: Australia
city: Douglas
country: Australia
city: Aalst
country: Belgium
city: Bonheiden
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Genk
country: Belgium
city: Leper
country: Belgium
city: Ottignies
country: Belgium
city: Brasilia
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Salvador
country: Brazil
city: Sao Jose
country: Brazil
city: Sao Paulo
country: Brazil
city: Uberlandia
country: Brazil
city: Cambridge
country: Canada
city: Hamilton
country: Canada
city: Laval
country: Canada
city: Longueuil
country: Canada
city: Montreal
country: Canada
city: Montreal
country: Canada
city: Montreal
country: Canada
city: St Jerome
country: Canada
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Cartagena
country: Colombia
city: Floridablanca
country: Colombia
city: Beroun
country: Czech Republic
city: Brno
country: Czech Republic
city: Brno
country: Czech Republic
city: Jihlava
country: Czech Republic
city: Kladno
country: Czech Republic
city: Liberec
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Prague
country: Czech Republic
city: Sternberk
country: Czech Republic
city: Vsetin
country: Czech Republic
city: Zlin
country: Czech Republic
city: Copenhagen
country: Denmark
city: Paris Cedex 18
country: France
city: Bad Nauheim
country: Germany
city: Dresden
country: Germany
city: Freiburg
country: Germany
city: Kassel
country: Germany
city: Neuss
country: Germany
city: Balatonfured
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Miskolc
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Ahmedabad
country: India
city: Ahmedabad
country: India
city: Ahmedabad
country: India
city: Hyderabaad
country: India
city: Hyderabaad
country: India
city: Mangalore
country: India
city: Nagpur
country: India
city: New Delhi
country: India
city: Tamil Nadu
country: India
city: Tirupati
country: India
city: Busan
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Inchon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Colonia Burocratas del Estado
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Merida
country: Mexico
city: Morelia
country: Mexico
city: Zapopan
country: Mexico
city: Amsterdam
country: Netherlands
city: Heerlen
country: Netherlands
city: Helmond
country: Netherlands
city: Hertogenbosch
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Nijmegen
country: Netherlands
city: Oss
country: Netherlands
city: Bialystok
country: Poland
city: Elblag
country: Poland
city: Gdansk
country: Poland
city: Inowroclaw
country: Poland
city: Krakow
country: Poland
city: Przemysl
country: Poland
city: Baia Mare
country: Romania
city: Braila
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Craiova
country: Romania
city: Oradea
country: Romania
city: Targoviste
country: Romania
city: Targu Mures
country: Romania
city: Chelyabinsk
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tyumen
country: Russian Federation
city: Tyumen
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Ruzomberok
country: Slovakia
city: George
country: South Africa
city: Johannesburg
country: South Africa
city: Kuilsriver
country: South Africa
city: Parow
country: South Africa
city: Pinelands
country: South Africa
city: Tongaat
country: South Africa
city: Umhlanga
country: South Africa
city: Western Cape
country: South Africa
city: Worcester
country: South Africa
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
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.