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 RUBY-1 study

INTERVENTION: Product Name: YM150 Product Code: YM150 Pharmaceutical Form: Tablet Current Sponsor code: YM150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: YM150 Product Code: YM150 Pharmaceutical Form: Tablet Current Sponsor code: YM150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: YM150 Product Code: YM150 Pharmaceutical Form: Tablet Current Sponsor code: YM150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: YM150 Product Code: YM150 Pharmaceutical Form: Tablet Current Sponsor code: YM150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: YM150 Product Code: YM150 Pharmaceutical Form: Tablet Current Sponsor code: YM150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: The investigation will be carried out on subjects with Acute Coronary Syndromes. ; MedDRA version: 12.0 Level: LLT Classification code 10049166 Term: Coronary artery thrombosis prophylaxis PRIMARY OUTCOME: Main Objective: • To evaluate the safety and tolerability of different doses and dose regimens of YM150 on top of standard treatment with Acetyl Salicylic Acid (ASA) with or without clopidogrel in the secondary prevention of Ischemic Vascular Events in Subjects with recent ACS Primary end point(s): The primary outcome variable is the incidence at six months of Major and Clinically Relevant Non Major (CRNM) bleeding events according to the ISTH definition (Schulman, 2005) and as determined by the IAC. Secondary Objective: Secondary Objectives:; • To evaluate the efficacy of different doses and dose regimens of YM150 on top of standard treatment with ASA with or without clopidogrel in the secondary prevention of Ischemic Vascular Events in Subjects with recent ACS,; • To compare safety, tolerability and efficacy of different doses and dose regimens of YM150 on top of standard treatment with ASA with or without clopidogrel against placebo.; ; Other Objectives:; • To assess Pharmacokinetic and Pharmacodynamic (PKPD) properties in the target population,; • To further define the suitable subject population for further development (i.e. P III).; INCLUSION CRITERIA: Inclusion criteria are: male or female subject who: 1. has a diagnosis of STE‐ACS, NSTE‐ACS as index event according to accepted guidelines such as the ESC or AHA guideline, 2. has elevated cardiac biomarkers (cardiac Troponin T or I or CKMB) > 2x ULN for CK‐MB or > ULN for troponin, 3. either has STE‐ACS or, for subjects with a diagnosis of NSTE‐SCE, at least one of the following additional high risk factors for ischemic events must be present: • New ST‐T deviations on Electrocardiogram (ECG) • Age of 65 years or older • Previous ACS < 12 months prior to randomization • Multi vessel Coronary Artery Disease (CAD) • Ischemic stroke or Transient Ischemic Attack (TIA) >12 months prior to randomization • Type 2 Diabetes Mellitus • Peripheral Arterial Disease (PAD), 4. is clinically stable which is defined as discontinuation of parenteral antithrombotics and is not likely to require reinstallment of parenteral antithromb