A PHASE 2, RANDOMIZED, PARALLEL GROUP, MULTI-CENTER, MULTI-NATIONAL STUDY FOR THE EVALUATION OF SAFETY OF FOUR FIXED DOSE REGIMENS OF DU-176b IN SUBJECTS WITH NON-VALVULAR ATRIAL FIBRILLATIO

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Subjects must meet all of the following criteria to be included in the study:

1.Male or female subject 18 to 85 years of age, inclusive;

2.Able to provide written informed consent;

3.Persistent non-valvular AF supported by abnormal ECG ( 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) at screening and baseline;

4.A CHADS2 index score of at least 2, indicating at least a moderate risk of stroke;

5.Women must be at least 2 years postmenopausal and/or prior total hysterectomy including bilateral oophorectomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following exclusion criteria will be excluded from the study:

1.Subjects with mitral valve disease or previous valvular heart surgery,

2.Presence of mechanical heart valves or bioprostheses,

3.Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin;

4.Known or suspected hereditary or acquired bleeding or coagulation disorder;

5.Subjects with conditions associated with high risk of bleeding such as past history of intracranial, intraocular, spinal, retroperitoneal or intra-articular bleeding; overt gastrointestinal bleeding or active ulcer within the previous year; recent trauma; uncontrolled hypertension (blood pressure [BP] above 180/100); hemorrhagic disorder; or significant thrombocytopenia;

6.Requirement for ongoing treatment with clopidogrel or ticlopidine;

7.AF secondary to other reversible disorders (eg, thyrotoxicosis);

8.Acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) (with or without stent), MI, stroke, or coronary artery or other cardiac or any other major surgery within the previous 30 days or subjects expected to require chronic thienopyridine anti-platelet therapy;

9.Subjects with active infective endocarditis;

10.Diagnosis of left ventricular aneurysm or atrial myxoma;

11.Unable to complete the study requirements due to a clinically relevant concomitant disease, as defined by the Investigator;

12.Disease or illness resulting in an estimated life expectancy of less than 12 months;

13.Invasive procedures planned or surgeries during the study period;

14.History of positive Hepatitis B antigen or Hepatitis C;

15.Impaired hepatic function, demonstrated by any of the following:
–AST = 1.5 times the ULN,
–ALT = 1.5 times the ULN,
–Total bilirubin >1.0 times the ULN,
–Alkaline phosphatase = 1.5 times the ULN;

16.Renal impairment (creatinine clearance <30 mL/min);

17.Subjects with hemoglobin <10 gm% or platelet count <100,000 cells/microlitre;

18.Subjects with WBC <3000 cells/microlitre;

19.Received any investigational drug or device within 3 months before study entry, or plan to receive such investigational therapy during the study period;

20.Previously enrolled in study of DU 176b;

21.Unlikely to comply with the protocol (eg, uncooperative attitude, inability to return for follow up visit and/or unlikely to complete the study);

22.Females of childbearing potential including women with a history of tubal ligation,

23.Subjects with cardiac pacemakers or implantable cardioverter-defibrillators (ICD);

24.Subjects with a history of alcohol and/or drug addiction;

25.Subjects with a history of HIV infection.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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