Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: MAA868; Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT03398434

CMAA868A2202

2017-002741-29 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups

MAA868 low dose regimen

Experimental group

Description:

patients receive dose monthly.

Treatment:

Drug: MAA868

MAA868 middle dose regimen

Experimental group

Description:

patients receive dose monthly.

Treatment:

Drug: MAA868

MAA868 high dose regimen

Experimental group

Description:

patients receive dose monthly.

Treatment:

Drug: MAA868

Apixaban

Active Comparator group

Description:

Apixaban 5 mg b.i.d

Treatment:

Drug: Apixaban