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Completed

NCT Number: NCT00938730

A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation

The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Ischemic Attack, Transient Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Auchenflower, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
  • Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit

Exclusion criteria

  • Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
  • Subject has active bleeding or any condition associated with increased risk of bleeding
  • Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
  • Subject has an indication for warfarin other than AF (including planned cardioversion)
  • Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
  • Subject has a diagnosis of left ventricular aneurysm or atrial myxoma
  • Subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics [such as tissue Plasminogen Activator (tPA), streptokinase], antiplatelet agents [such as cilostazol, clopidogrel, ticlopidine, dipyridamole], anticoagulants [such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors] and chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs] or acetylsalicylic acid use of >100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
  • Subject has active infective endocarditis
  • Subject is planned for invasive procedures with potential for bleeding
  • Subject 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
  • Subject has participated in any YM150 clinical trials

Treatment and study plan

YM150

Drug

oral

Warfarin

Drug

oral

Primary outcomes

  1. Incidence of major and clinically relevant non-major bleeding events

    Time frame: Double-blind treatment period (variable, up to 16 months)

Secondary outcomes

  1. Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths

    Time frame: Double-blind treatment period (variable, up to 16 months)

  2. Incidence of bleeding events

    Time frame: Double-blind treatment period (variable, up to 16 months)

  3. Assessment of other safety variables

    Time frame: Double blind treatment period (variable, up to 16 months)

  4. Assessment of PK/PD variables

    Time frame: Double-blind treatment period (up to week 12)

  5. Patient Reported Outcomes

    Time frame: Double-blind treatment period (up to week 24)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With Warfarin

Acronym: OPAL-2

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 14, 2009
Registry last updated
Jan 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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