Blod clotting in patients irregular heart rhythm: the effect of dabigatra

Phase 1

Conditions: Atrial fibrillation
MedDRA version: 17.1Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-004357-13-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with atrial fibrillation

1. Patients with non-valvular atrial fibrillation, who are to begin dabigatran treatment
2. Age = 18 years

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Persons, who can not give informed consent
2. treatment with platelet inhibitors, heparin, warfarin, direct anti-xa inhibitors or other medical therapy or supplements that may affect blod coagulation processes.
3. change in the other medication within 14 days before enrollment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To investigate the effects of dabigatran on measurements of platelet function<br>;Secondary Objective: 2. To investigate the effect of dabigatran on other laboratory parameters <br> 3. Describe the effect of atrial fibrillation on platelets;Primary end point(s): Extent of thrombin receptor activating peptide induced platelet aggregation ;Timepoint(s) of evaluation of this end point: For each person the endpoint is determined within two hours from blood collection. The data for the study is evaluated after last subject's last visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Extent of collagen and adenosine diphosphate induced platelet aggregation and platelet function by flow cytoemtry. International normalized ratio and activated partial thromboplastin time;Timepoint(s) of evaluation of this end point: For each person the endpoint is determined within four hours from blood collection. The data for the study is evaluated after last subject's last visit