None listed
Conditions
Interventions
Group 1 Type of group
Patients will be treated once a day in the morning with AZD0837 350 mg (± 175 mg)
Group name:Group 2 Type of group
Patients will be treated once a day in the morning with warfarin looking for a 2.0 to 3.0 RIN, 2.5 objective RIN.
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Provision of informed consent prior to any specific study procedure. • Woman or man> 18 years old • Rhythm Verification • Stroke risk classification at least one of the risk factors
Exclusion criteria
Exclusion criteria: • Fertile women without a reliable contraceptive method, in the opinion of the Researcher, before and during participation in the study. • Breastfeeding • AF secondary to a current reversible disorder (eg, hyperthyroidism, isolated postoperative AF, drugs and pulmonary embolism) • Allergy and / or intolerance to AVK • Valvular heart disease • Active infectious endocarditis • Any other condition other than AF that requires chronic anticoagulant treatment • myocardial infarction (MI), cardiac surgery (eg, coronary artery bypass graft, CABG) and / or percutaneous coronary intervention (PCI) within 3 months prior to enrollment. Any PCI that requires treatment with clopidogrel at the time of enrollment. • Stroke, TIA and / or systemic embolism within 14 days prior to randomization • Known bleeding disorders and / or conditions associated with increased risk of major bleeding • Severe renal impairment (calculated creatinine clearance (CrCl) 3 x LSN and / or bilirubin> 2 x LSN • Uncontrolled hypertension, systolic blood pressure> 180 mmHg • Anemia (Hb <100 g / 1 = 6.2 mmol / I) and / or platelet count <100 x 10 ^ / 1 • Scheduled pulmonary vein ablation procedure, PCI or major surgery. Programmed cardioversion (direct current (CD) or pharmacological) within the month of randomization. • Another serious illness with an estimated survival of less than 12 months, any condition that causes the patient to be too weak to participate in the study, and / or inability to complete the study according to the protocol. Severe neurological deficit or disability that interferes with the detection and / or evaluation of a new cerebrovascular event • Known drug addiction or alcohol abuse • Enrollment or randomization to the previous treatment in the present study and / or participation in previous studies with AZD0837. • Participation in another clinical study with IP and / or intervention during the last 3 months. • Participation in the planning and / or conduct of the study (applies to both AstraZeneca staff and the study center).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A cerebrovascular accident is defined as a focal neurological deficit caused by an ischemic or hemorrhagic event of the central nervous system, with residual symptoms at least 24 hours after the onset or causing death. Measure:Outcome composed of stroke and SES in each patient Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:TIA is defined as a focal neurological deficit that resolves spontaneously without any evidence of residual deficit within 24 hours. At a minimum, the diagnosis of TIA requires at least 1 major symptom (unilateral weakness of 2 or more areas of the body (face, arm, trunk, leg), inability to speak, loss of visual field) or 2 minor symptoms (diplopia , vertigo or disturbances in walking, dysarthria, dysphagia, dysphonia or unilateral numbness). Measure:Appearance of transient ischemic attack Timepoints:During the study ; Outcome name:Total mortality includes all deaths, that is, CV and not CV. When possible, the classification should be based on the results of the autopsy. Measure:Total mortality Timepoints:During the study ; Outcome name:CV mortality includes death from CV disease, cerebrovascular disease and any other vascular abnormality, as well as deaths without a documented non-vascular cause. Measure:Cardiovascular mortality Timepoints:During the study | — |
Countries
Bulgaria, Denmark, France, Hungary, Peru, Slovakia, Spain, Sweden
Contacts
Public ContactUrsula Isabel Rodriguez-Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed