Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03398434
• Date of registration: 08/01/2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation
• Scientific title: 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
• Date of first enrolment: October 16, 2018
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03398434
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Key inclusion & exclusion 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



Age minimum: 55 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: MAA868

Drug: Apixaban

Primary Outcome(s)

number of patients achieving FXI inhibition = 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition [Time Frame: month 3]

Secondary Outcome(s)

Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period. [Time Frame: day 1 to day 91]

the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator [Time Frame: Days 31, 61 and 91]

number of patients achieving FXI inhibition = 80% at trough after the first and second dose at 3 dose levels of MAA868 [Time Frame: Month 1 and 2]

Secondary ID(s)

CMAA868A2202

2017-002741-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors