Potential influence of coagulation inhibitionon the perception of fear or aggressiveness

• Conditions: I48; Atrial fibrillation and flutter

• Registration Number: DRKS00017043
• Lead Sponsor: niversitätsklinik für Kardiologie und Angiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Treatment group: Patients receiving dabigatran under one of the approved indications, e.g. non-valvular atrial fibrillation, thrombosis, pulmonary embolism or control group: Patients who, after clarifying questionable cardiac arrhythmias, do not require further drug or pacemaker treatment

Exclusion Criteria

a) contraindications for dabigatran, e.g. Hypersensitivity to the active substance or to any of the excipients, severe renal insufficiency (creatinine clearance [CrCl] <30 ml / min), acute clinically relevant bleeding, organ damage increasing the risk of bleeding, spontaneous or pharmacological limitation of haemostasis, severe liver disease, concomitant systemically administered ketoconazole, cyclosporin, itraconazole or tacrolimus; Pat. With artificial heart valves.
b) Severe infections, trauma, tumors or terminal diseases that affect the brain.
c) Lack of consent.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Treatment arm:<br><br>Change in timidity under anticoagulant therapy: Hamilton anxiety scale / HAM-A<br><br>- control group:<br><br>Change in timidity under anticoagulant therapy: Hamilton anxiety scale / HAM-A<br><br>-exploratory analysis

Secondary Outcome Measures

Name	Time	Method
<br>Altering Anxiety with Anticoagulant Therapy: State Trait Anger Expression Inventory / STAXI<br>