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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994292

Acronym

RUBY-1

Enrollment

1276

Registered

2009-10-14

Start date

2009-09-30

Completion date

2011-03-31

Last updated

2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Factor Xa, Anticoagulant, YM150, Acute Coronary Syndrome

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.

Interventions

DRUGYM150

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition	6 Months

Secondary

Measure	Time frame
Incidence of Major and Clinically Relevant Non Major bleeding events	30 Days

Countries

Argentina, Australia, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, France, Germany, Hungary, India, Mexico, Netherlands, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026