dabigatran and rivaroxaban: prediction of anticoagulant effect

Completed

• Conditions: atrial fibrillation; 10007521

• Registration Number: NL-OMON37535
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

* Men and women aged 18 to 80 years newly diagnosed with non valvular AF ;* Signed written consent to take part in the study

Exclusion Criteria

* Previous history of thrombotic or major bleeding event;* Known to have prothrombotic risk factors;* Use of oral anticoagulants;* Creatinine clearance < 30 ml/min;* Heart valve problems

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/ endpoints: The main study parameter is thrombin<br /><br>generation. In addition, liver enzymes and renal function will be measured, as<br /><br>well as several additional tests for coagulation status. The end-point will be<br /><br>the variation in anticoagulant effect in different patients and the correlation<br /><br>between in vivo and in vitro (anticoagulant) effects of rivaroxaban or<br /><br>dabigatran. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>