Prevention of stroke on patients with Non-Valvular Atrial Fibrillation MedDRA version: 8.1 Level: LLT Classification code 10049165 Term: Cerebrovascular accident prophylaxis
Conditions
Interventions
Product Name: YM150
Product Code: YM150
Pharmaceutical Form: Tablet
Current Sponsor code: YM150 (as monomaleate)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Sponsors
Astellas US Pharma US Inc.(APUS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations, must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). 2. Male or female subject is greater than or equal to 18 years of age. 3. Female subject of childbearing potential has a negative pregnancy test within 14 days prior to baseline/first dose of study drug OR is 2 years postmenopausal or surgically sterile. 4. Subject has permanent (documented by two ECGs within 3 months of randomization) or paroxysmal Non Atrial Valvular Fibrillation (NVAF) (documented on a 24 hour Holter monitor performed within 3 months of randomization). 5. Subject has prothrombin time international normalized ratio (INR) of 2.0 or below and an aPTT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subject is pregnant or lactating. 2. Subject has current or recent (within previous 2 years) history of stroke and/or systemic embolism (including TIA). 3. Subject has active bleeding or any condition associated with increased risk of bleeding. 4. Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis). 5. Subject has an indication for warfarin other than AF (including mechanical heart valves, venous thromboembolism and planned cardioversion). 6. Subject has had myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months or diagnosis of Acute Coronary Syndrome (ACS). 7. Subject has a diagnosis of left ventricular aneurysm or atrial myxoma. 8. Subject requires use of prohibited concomitant medication (i.e. chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), thrombolytics or aspirin use of >100 mg/day) currently and for the duration of the study. 9. Subject has hematuria. 10. Subject has renal impairment (calculated creatinine clearance 2 times the upper limit of normal. 12. Subject has bacterial endocarditis. 13. Subject has uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure > 110 mmHg). 14. Subject has history of rheumatic fever. 15. Subject has hemoglobin <10 g/dl or platelet count <100,000/µL. 16. Subject has any contraindications to warfarin. 17. Subject is a candidate for invasive procedures with potential for uncontrolled bleeding, including major surgery. 18. Subject has any concurrent illness which, in the opinion of the Investigator, may interfere with treatment or evaluation of safety or completion of this study. 19. Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days of screening for entry into the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation. ;Secondary Objective: To obtain information on pharmacokinetics and pharmacodynamics (antithrombotic potential) in the target population.;Primary end point(s): Bleeding events, stroke, TIA and systemic thromboembolic events. | — |
Countries
Czech Republic, Denmark
Outcome results
None listed