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

ovartis Pharma AG0 个研究点目标入组 600 人开始时间: 2017年12月11日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•- 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.
•- See full inclusion criteria in study protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 420

•- 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.
•- See full exclusion criteria in study protocol.

发起方