Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03398434
• Other study ID #: CMAA868A2202
• Secondary ID: 2017-002741-29
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 16, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: October 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2020
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• MAA868
3 MAA868 doses, single administration, subcutaneous,
• Apixaban
Apixaban 5 mg b.i.d

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients achieving FXI inhibition = 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition	Occurrence of achieving = 80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.	month 3
Secondary	number of patients achieving FXI inhibition = 80% at trough after the first and second dose at 3 dose levels of MAA868	Occurrence of achieving = 80% inhibition of FXI (< 20% free FXI) at trough on Month 1 and Month 2	Month 1 and 2
Secondary	Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.	Incidence of major or clinically relevant non-major bleeding events	day 1 to day 91
Secondary	the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator	Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).	Days 31, 61 and 91