Vitamin K antagonist (VKA) therapy versus New Oral Anticoagulants (NOACs) therapy in patients with currently well controlled VKA therapy for non-valvular atrial fibrillation: a pilot study
Phase 4
Completed
- Conditions
- atrial fibrillationcardiac arrhythmia10007521
- Registration Number
- NL-OMON41389
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints:<br /><br>· Primary: net clinical benefit (stroke, major bleeds, systemic embolism,<br /><br>myocardial infarction, vascular death)<br /><br>· </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: safety (major bleeds, clinically relevant non-major bleeds,<br /><br>all-cause mortality), efficacy (ischemic/unspecified stroke, systemic embolism,<br /><br>myocardial infarction, vascular death), burden of complications,</p><br>