Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes (RUBY-1)
This study has been completed.
Sponsor:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT00994292
First received: October 13, 2009
Last updated: September 29, 2015
Last verified: September 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: YM150 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of Major and Clinically Relevant Non Major bleeding events [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
| Enrollment: | 1276 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. YM150 Dose V, twice daily |
Drug: YM150
oral
|
| Experimental: 2. YM150 Dose W, once daily |
Drug: YM150
oral
|
| Experimental: 3. YM150 Dose X, twice daily |
Drug: YM150
oral
|
| Experimental: 4. YM150 Dose Y, once daily |
Drug: YM150
oral
|
| Experimental: 5. YM150 Dose Y, twice daily |
Drug: YM150
oral
|
| Experimental: 6. YM150 Dose Z, once daily |
Drug: YM150
oral
|
| Placebo Comparator: 7. Placebo |
Drug: Placebo
oral
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00994292
Show 131 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994292
Show 131 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
| Study Director: | Use Central Contact | Astellas Pharma Europe B.V. |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Astellas Pharma Europe B.V. |
| ClinicalTrials.gov Identifier: | NCT00994292 History of Changes |
| Other Study ID Numbers: | 150-CL-201 2008-005972-29 |
| Study First Received: | October 13, 2009 |
| Last Updated: | September 29, 2015 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Brazil: Ministry of Health Canada: Health Canada Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Mexico: Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control South Africa: Department of Health South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Astellas Pharma Inc:
|
Factor Xa Anticoagulant YM150 Acute Coronary Syndrome |
Additional relevant MeSH terms:
|
Syndrome Acute Coronary Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Darexaban Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |
ClinicalTrials.gov processed this record on September 23, 2016