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

Acute Coronary Syndrome Clinical Trial

— RUBY-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994292
• Other study ID #: 150-CL-201
• Secondary ID: 2008-005972-29
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2009
• Last updated: September 29, 2015
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: Ministry of HealthCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIndia: Central Drugs Standard Control OrganizationMexico: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Africa: Department of HealthSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Ukraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 syndromes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1276
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• YM150
oral
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Brazil,  Canada,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Hungary,  India,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition		6 Months	Yes
Secondary	Incidence of Major and Clinically Relevant Non Major bleeding events		30 Days	Yes

External Links

•   Link to Results on JAPIC