Research on anticoagulant treatment in atrial fibrillatio

Phase 1

• Conditions: non-valvular atrial fibrillation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-004805-14-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-09
• Study Completion: 2017-10-17
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 241

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

-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 clinical trial of medicinal product
• Study Design: Not specified