Stroke Prevention by ORal Thrombin Inhibition V "SPORTIF V"


Phase N/A Results

Eligibility Criteria

Inclusion Criteria

Patients with chronic, non-valvular atrial fibrillation who have at least one of the following stroke risk factors: hypertension that requires treatment, but is below 180/100 mmHg, age > 75 years, history of previous stroke, transient ischemic attack (TIA), or systemic embolism, a left ventricular ejection fraction (LVEF) <40%, symptomatic congestive heart failure (CHF), or age > 65 years in combination with either coronary artery disease or diabetes mellitus, will be eligible for this trial.

Exclusion Criteria

Patients who have a history of stroke within the past 30 days or TIA within the past 3 days, who have of the any following conditions associated with an increased risk of bleeding: a history of intracranial, intraocular, spinal retroperitoneal or atraumatic intra-articular bleed, an overt gastrointestinal bleed within the past year, endoscopically-verified ulcer disease, surgical procedure, or trauma within the past 30 days, blood pressure consistently > 180/100 mmHg (with or without antihypertensive therapy), or a hemorrhagic disorder , who have lone atrial fibrillation without overt cardiovascular disease or a precipitating illness, transient atrial fibrillation caused by reversible disorders, rheumatic valve disease, a prosthetic heart valve or a history of valvular surgery, active endocarditis, current atrial myxoma or left ventricular thrombus, a history of hospitalization for acute coronary syndromes or percutaneous coronary artery interventions within the past 30 days, or have a planned electircal or chemical cardioversion, who have been treated with antiplatelets within the past 10 days or fibrinolytics within the past 20 days, who use other anticoagulants, aspirin > 100 mg/day, or continuously take NSAIDs, who require for chronic anticoagulant treatment for a reason other than atrial fibrillation (e.g. repeated deep vein thrombosis, hereditary thrombophilia), who have renal impairment (creatinine clearance < 30 mL/min), active liver disease, anemia, any history of a significant disabling stroke, or who have any planned major surgery, are excluded from this trial.