A controlled, randomised, double-blind, double-dummy, parallel-group, phase III, multicenter study to evaluate efficacy and safety of the oral direct thrombin inhibitor AZD0837 compared to warfarin for the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (ASSURE-AF) - ASSURE-AF

Not Applicable

Conditions: -I48 Atrial fibrillation and flutter
Atrial fibrillation and flutter
I48

Registration Number: PER-150-08

Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 0

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

• 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) <30 ml / min)
• Known liver disease and / or ALAT> 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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.<br>Measure:Outcome composed of stroke and SES in each patient<br>Timepoints:During the study<br>

Secondary Outcome Measures

Name	Time	Method
<br>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).<br>Measure:Appearance of transient ischemic attack<br>Timepoints:During the study<br>;<br>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.<br>Measure:Total mortality<br>Timepoints:During the study<br>;<br>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.<br>Measure:Cardiovascular mortality<br>Timepoints:During the study<br>

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