A multicenter, randomized, open-label, active-controlled, dose-range finding study to assess the pharmacodynamic parameters, safety and tolerability of MAA868 and its effect on thrombogenesis biomarkers compared to apixaban in patients with atrial fibrillation - CMAA868A2202

ovartis0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- Male and female patients * 55 and 85 years old
•- Body weight between 50 and 130 kg inclusive
•- Atrial fibrillation or atrial flutter, as documented by electrocardiography
•- CHA2DS2-VASc risk score * 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.
•- Either anticoagulant-naïve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.

•- History of stroke, transient ischemic attack or systemic embolism.
•- History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months.
•- History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular 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 hemodynamically significant valvular heart disease.
•- Uncontrolled hypertension defined as SBP/DBP * 160/100 mmHg at the screening visit.
•- Heart failure NYHA class IV in the 3 months prior to the screening visit.
•- Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (* 100 mg/d) is allowed but not both.
•- Severe renal impairment (creatinine clearance 30 mL/min) at the screening visit.

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