Clinical Trials/NCT03398434

NCT03398434

Withdrawn

Phase 2

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

Novartis Pharmaceuticals0 sitesOctober 16, 2018

ConditionsAtrial Fibrillation

InterventionsMAA868 Apixaban

DrugsMAA868 Apixaban

Overview

Phase: Phase 2
Intervention: MAA868
Conditions: Atrial Fibrillation
Sponsor: Novartis Pharmaceuticals
Primary Endpoint: number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 16, 2018

End Date

January 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

MAA868 low dose regimen

patients receive dose monthly.

Intervention: MAA868

MAA868 middle dose regimen

patients receive dose monthly.

Intervention: MAA868

MAA868 high dose regimen

patients receive dose monthly.

Intervention: MAA868

Apixaban

Apixaban 5 mg b.i.d

Intervention: Apixaban

Outcomes

Primary Outcomes

number of patients achieving FXI inhibition ≥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition

Time Frame: month 3

Occurrence of achieving ≥ 80% inhibition of FXI (\< 20% free FXI) following 3 months of treatment.

Secondary Outcomes

number of patients achieving FXI inhibition ≥ 80% at trough after the first and second dose at 3 dose levels of MAA868(Month 1 and 2)
Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.(day 1 to day 91)
the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator(Days 31, 61 and 91)