Antithrombotic treatment for prevention of stroke in patients with non-valvular atrial fibrillation MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Conditions
Interventions
Product Name: Betrixaban Maleate
Product Code: Betrixaban
Pharmaceutical Form: Capsule, hard
Current Sponsor code: Betrixaban
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Portola Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age =18 years. 2. If the patient is a woman, she must be without reproductive potential (i.e., postmenopausal for =2 years or after hysterectomy). 3. AF or atrial flutter at the time of enrollment (randomization) or documented within the last year by Holter, ECG, rhythm strip, pacemaker or other intracardiac recording, resulting in an indication for anticoagulation with warfarin or other vitamin K antagonist in the opinion of the treating physician. 4. One or more of the following risk factor(s) for stroke: a. Age 75 years or older. b. Prior stroke, TIA or systemic (i.e., non- central nervous system) embolus at least 30 days remote from the time of screening. c. Symptomatic congestive heart failure within 3 months or left ventricular dysfunction with an LVEF =45% by echocardiography, radionuclide study or contrast angiography. d. Hypertension requiring pharmacological treatment. e. Diabetes. f. Age of 55 years or older and previous coronary artery disease or known peripheral artery disease. 5. INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Body weight less than 40 kg (88 lbs). 2. Need for either hemodialysis or peritoneal dialysis (or likely to require it within one year). 3. AF due to reversible causes (e.g., thyrotoxicosis, pericarditis, cardiac surgery, pulmonary embolism). 4. Mechanical prosthetic valve (bioprosthetic valve is allowed) or valvular disease likely to be operated on within one year. 5. Active bleeding or history (including family history) or symptoms of a congenital or acquired bleeding disorder or vascular malformation; or a history of intracranial, retroperitoneal, or intraocular bleeding within the last 6 months; or is felt to be at high risk for bleeding for other reasons including from significant liver disease. This also includes gastrointestinal bleeding within 90 days before randomization or endoscopically verified ulcer disease within 30 days of screening. 6. Conditions other than AF that require chronic anticoagulation (e.g. prosthetic mechanical heart valve). 7. Persistent, uncontrolled hypertension (SBP >160 mm Hg on repeated measurements). 8. Active infective endocarditis. 9. Scheduled major surgery. 10. Planned pulmonary vein ablation or surgical procedure for cure of AF or flutter. 11. Recent ischemic stroke, systemic embolic event or acute coronary syndrome within 30 days. 12. Severe co-morbid condition with life expectancy of =1 year. 13. Previous known history of genetic coagulopathy (e.g., Factor V Leiden, Protein C Deficiency, Protein S Deficiency, Antiphospholipid Syndrome, etc.). 14. Evidence at Screening of:a. Platelet count 2.5 times ULN.c. A history (including family history) of “Long QT Syndrome”. 15. Aspirin >162 mg daily. 16. Use of verapamil (pending the availability of a drug interaction study with betrixaban). 17. Active alcohol or drug abuse, or psychosocial reasons that make study participation impractical. 18. Use of an investigational drug or device within the past 30 days. 19. Inability to comply with INR monitoring or other protocol-related activities. 20. Positive stool occult blood test, except if explained by a known diagnosis indicating a low risk of bleeding (e.g. hemorrhoids or benign polyp) 21. Scheduled cardioversion or those patients who are likely to undergo cardioversion in the next 1 year. Patients who have had cardioversion at least 30 days prior to screening can be entered in the study. 22. Unable to give written informed consent. 23. A known atrial or ventricular thrombus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to assess the safety and tolerability of betrixaban at doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to a dose-adjusted Vitamin K antagonist in patients with non-valvular AF.;Secondary Objective: To provide preliminary efficacy data on betrixaban at fixed doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to a dose-adjusted vitamin K antagonist in patients with non-valvular AF. To assess the PK and PD of betrixaban at the above doses in the target population.;Primary end point(s): The primary endpoint will be the time to occurrence of major or clinically relevant non-major bleeding. | — |
Countries
Germany
Outcome results
None listed