Status:
COMPLETED
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
Lead Sponsor:
Astellas Pharma Europe B.V.
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1276 Patients enrolled
Trial Details
Trial ID
NCT00994292
Start Date
September 1 2009
End Date
March 1 2011
Last Update
October 19 2015
Active Locations (131)
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1
Buenos Aires, Argentina, C1280AEB
2
Corrientes, Argentina, W3400AMZ
3
Salta, Argentina, A4400AWG
4
Salta, Argentina, A4406CLA