Overview

Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation

Status:
Withdrawn
Trial end date:
2020-01-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Apixaban
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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