A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillatio
- Conditions
- -I48 Atrial fibrillation and flutterAtrial fibrillation and flutterI48
- Registration Number
- PER-055-07
- Lead Sponsor
- DAIICHI SANKYO PHARMA DEVELOPMENT,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Be a male or female subject of 18 to 80 years of age.
2. Be able to give written informed consent.
3. Have a diagnosis of persistent non-valvular AF based on abnormal electrocardiographic data.
4. Have a CHADS2 score of no less than 2.
5. Women should have a postmenopausal period of ≥ 2 years or a serum level of follicle-stimulating hormone (FSH) greater than 35 mlU / ml, have been surgically sterilized or use medically accepted barrier methods of contraception.
1. Mitral valve disease or previous valvular heart surgery.
2. Presence of bioprostheses or mechanical heart valves.
3. Known contraindication to any anticoagulant.
4. Haemorrhagic or coagulation disorder.
5. Conditions associated with a high risk of hemorrhage.
6. Need for permanent treatment with clopidogrel or ticlopidine.
7. FA as a side effect of other reversible disorders.
8. Acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), MI, stroke or coronary artery surgery or other cardiac surgery or other major surgery in the last 30 days, or expectation of need for chronic antiplatelet therapy with thienopyridine .
9. Active infectious endocarditis.
10. Diagnosis of left ventricular aneurysm or atrial myxoma.
11. Inability to meet the requirements of the study.
12. Illness that reduces the estimated life expectancy to less than 12 months.
13. Scheduled invasive procedures or surgeries performed during the study period.
14. History of positive results in the hepatitis B or hepatitis C antigen test.
15. Impaired liver function.
16. Renal insufficiency.
17. Hemoglobin level <10 g% or platelet count <100,000 cells / ul.
18. Leukocyte count <3000 cells / ul.
19. Implantation of any device or administration of any investigational medication in the 3 months prior to study entry, or plans to receive that investigational treatment during the study period.
20. Previous registration in a DU-176B study.
21. Unlikely to comply with the protocol.
22. Pregnancy, potential pregnancy or lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Criterion 1: Elevated peripheral blood levels of liver enzymes ≥ 3 times the upper limit and bilirubin ≥ 2 times the upper limit.<br>Criterion 2: Clinical identification of: A) Major bleeding events: Symptomatic hemorrhage in critical areas or organs (Retroperitoneal, Intracranial, Intraocular, Intraspinal, Intra-auricular or pericardial and Intramuscular with compartment syndrome) or Any other obvious hemorrhagic event, associated with one of the following results: Death, drop in hemoglobin level ≥ 2 g / dl, transfusion of ≥ 2 units of erythrocyte concentrate or whole blood. B) Other clinically relevant events.<br>Measure:Safety: 1) Elevated levels of liver enzymes, bilirubin or both. 2) Major bleeding events, other clinically important bleeding events, or both.<br>Timepoints:Days 1, 7, 14, 21, 21, 28, 42, 56, 70, 84 and 30 days after the last dose.<br>
- Secondary Outcome Measures
Name Time Method