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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: YM150
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. YM150 Dose V, twice daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 2. YM150 Dose W, once daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 3. YM150 Dose X, twice daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 4. YM150 Dose Y, once daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 5. YM150 Dose Y, twice daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 6. YM150 Dose Z, once daily<br> | Drug: YM150<br>* oral<br>|
| Placebo Comparator: 7. Placebo<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major and Clinically Relevant Non Major bleeding events |  | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Factor Xa, Anticoagulant, YM150, Acute Coronary Syndrome