Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects with Acute Coronary Syndromes
- Registration Number
- CTRI/2009/091/000988
- Lead Sponsor
- Astellas Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1264
Inclusion:
1) has a diagnosis of STE-ACS, NSTE-ACS as index event according to accepted guidelines such as the ESC or AHA guidelines,
2) has elevated cardiac biomarkers
Exclusion:
1) 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,
2) has had recent stroke or TIA ≤ 12 months prior to index event,
3) has persistent BP of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher at baseline with or without medication,
4) 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,
5) has participated in any YM150 clinical trials
6) requires ongoing parenteral or oral anticoagulant therapy
7) has active bleeding or is in the opinion of the investigator at high risk of bleeding during the study,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition.<br><br>Timepoint: Timeframe: 6 months.<br>
- Secondary Outcome Measures
Name Time Method Incidence of Major and Clinically Relevant Non Major bleeding events.Timepoint: Timeframe: 30 days.