atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Code: MAA868
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: not available
Current Sponsor code: MAA868
Other descriptive name: MAA868
Concentration unit: mg/m
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients = 55 and =65 years) yes F.1.3.1 Number of subjects for this age range 420
Exclusion criteria
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. - See full exclusion criteria in study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Occurrence of achieving =80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.;Secondary Objective: - Occurrence of achieving =80% inhibition of FXI (< 20% free FXI) at trough on Month 1 and Month 2. - Incidence of major or clinically relevant non-major bleeding events. - Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombinantithrombin III-complexes (TAT), fibrinogen).;Primary end point(s): Number of patients achieving FXI inhibition =80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition.;Timepoint(s) of evaluation of this end point: month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients achieving FXI inhibition = 80% at trough after the first and second dose at 3 dose levels of MAA868. - Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period. - The effect of MAA868 on D-dimer and other thrombogenesis biomarkers as indicators of efficacy compared to comparator.;Timepoint(s) of evaluation of this end point: - Month 1 and 2. - Day 1 to day 91. - Days 31, 61 and 91. | — |
Countries
Finland, Germany, Hungary, Iceland, Japan, Netherlands, Russian Federation, Sweden, Switzerland, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed