A phase 3, randomised, double-blind, double dummy, parallel group, multi-centre, multi-national study for evaluation of efficacy and safety of du-176b verses warfarin in subjects with atrial fibrillatio
- Conditions
- Atrial FibrillationCardiovascular - Normal development and function of the cardiovascular systemCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12609000132246
- Lead Sponsor
- Daiichi Sankyo Pharma Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 16500
1.Male or female subjects with age = 21 years;
2.Able to provide written informed consent;
3.History of Atrial Fibrillation (AF) documented by a 12-lead electrocardiographic reading and/or continuous electrocardiogram (ECG) (e.g., Holter monitoring) consistent with Atrial Fibrillation (AF) (notation of AF as the abnormal rhythm on the local ECG report with evidence of irregularly irregular rhythm and an absence of P-waves on the ECG for diagnosis of AF) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study, including subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous vitamin K antagonist (VKA) (including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
4.A moderate to high risk of stroke, as defined by Scoring system Congestive Heart Failure, Hypertension, Age, Diabetes, previous stroke (CHADS2) index score of at least 2, is required to be eligible for the study. The CHADS2 scoring is performed by assigning 1 point each for a history of congestive heart failure, hypertension, age 75 years, or diabetes mellitus; and by assigning 2 points for history of stroke or Trans Ischemic Attack (TIA).
1Transient AF secondary to other reversible disorders
2Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
3Subjects with any contraindication for anticoagulant agents;
4Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
5Females of childbearing potential including the following:
a)Females with a history of
tubal-ligation;
b) Females less than 2 years
post-menopausal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to compare DU-176b to warfarin with regard to the composite primary endpoint of stroke and Systemic embolic event (SEE). Each DU-176b regimen will be compared with warfarin for non-inferiority. Any non-inferior DU-176b regimen will be compared with warfarin for superiority.<br>Stroke and systemic embolic events will be assessed utilising Hospital and Doctor Records[2 years, this is an event driven study so will be assessed every time there is an event utnil the number of required events are collected. This could mean that the study is shorter or longer in duration than 2 years. The number of events needed is 448 events in each of the three study arms.]
- Secondary Outcome Measures
Name Time Method 1.To compare DU-176b to warfarin with regard to major bleeding as well as major plus clinically relevant non-major bleeding.<br>This outcome will be measured as follows:Hospital and or Doctor records.[At study end:this is an event driven study so will be assessed every time there is an event utnil the number of required events are collected. This could mean that the study is shorter or longer in duration than 2 years. There will be 448 events collected from each of the three arms of the study]