Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Anthos Therapeutics, Inc.
With
Covance
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female patients ≥ 18 and \< 85 years old with paroxysmal atrial fibrillation (PAF) or atrial flutter on 12 lead electrocardiography at Screening Or
Patients with a history of PAF or atrial flutter, as documented by (telemetry, 12 lead electrocardiography or ambulatory \[e.g. Holter\] monitor) and not due to a reversible condition (e.g. alcohol binge drinking) can be entered even if they do not have PAF at Screening. There is not time-limit for this.
Patients with a Congestive heart failure, Hypertension, Age ( \> 65 = 1 point, \> 75 = 2 points), Diabetes, previous Stroke/transient ischemic attack (2 points) (CHA2DS2-VASc) risk score (tool as a predictor for estimating the risk of stroke in patients with atrial fibrillation (AF); Lip et al 2010) of 0-1 for men and 1-2 for women and in whom, in the investigator's judgment, the use of an anticoagulant for stroke prevention is not indicated
You may not be if
History of stroke, transient ischemic attack or systemic embolism
History of major bleeding during treatment with an anticoagulant or antiplatelet therapy. (Patients who have had major bleeding on anticoagulants or antiplatelet therapy more than a year ago can be enrolled only if the bleeding was due to a reversible cause, e.g. gastro-duodenal ulcer that was successfully treated.)
History of traumatic or non-traumatic intracranial, intraspinal or intraocular bleeding
Known bleeding diathesis or any known active bleeding site at screening or baseline
Family history of bleeding disorder
Known active GI lesions predisposing to bleeding events
Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the Screening period
Known clinically significant valvular heart disease including moderate or severe mitral stenosis (valve area \<1.5 cm2)
Patients with a prosthetic heart valve
Clareo Health | A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation