non-valvular atrial fibrillation
Conditions
Interventions
Product Code: B01AA07
Pharmaceutical Form: Tablet
INN or Proposed INN: ACENOCOUMAROL
CAS Number: 152-72-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1 -
Produ
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or women aged >18 years who are currentlly treated with VKA for non-valvular AF, managed by participating Thrombosis Service -A minimum duration of 6 months of VKA treatment prior to the screening visit. - An ITTR> 60% over the 4 months of VKA treatment before selection by the Thromobosis Service D4b. In het Nederlands Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: -thrombo-embolic event or major bleeding ever while on VKA -Indication for anticoagulation other then AF -contra-indication to receive NOACs, i.e. reduced renal clearance defined as <30ml/min (Cockroft-Gault formula)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectives: To collect data on effect size for, and determine the feasibility of, a full scale multicentre RCT (Randomized Controlled Trial) that 1. compares the efficacy and safety of NOACs with VKA treatment according to Dutch standards, in VKA-experienced patients with currently well controlled VKA therapy, in the Dutch real-life setting 2. compares differences in treatment satisfaction, compliance and quality of life between NOACs and VKA treatment.;Primary end point(s): Main study parameters/endpoints: · Primary: net clinical benefit (stroke, major bleeds, systemic embolism, myocardial infarction, vascular death);Secondary Objective: Secondary: safety (major bleeds, clinically relevant non-major bleeds, all-cause mortality), efficacy (ischemic/unspecified stroke, systemic embolism, myocardial infarction, vascular death), burden of complications,;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: safety (major bleeds, clinically relevant non-major bleeds, all-cause mortality), efficacy (ischemic/unspecified stroke, systemic embolism, myocardial infarction, vascular death), burden of complications,;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Netherlands
Contacts
Public ContactThrombosis Service
Thrombosis Service
Outcome results
None listed