Status:
WITHDRAWN
Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03398434
Start Date
October 16 2018
End Date
January 30 2020
Last Update
October 8 2020
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