Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes (RUBY-1)
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ClinicalTrials.gov Identifier: NCT00994292
Recruitment Status :
First Posted : October 14, 2009
Last Update Posted : October 19, 2015
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
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.
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
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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