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

Coagaulation in patients with atrial fibrillation: The effect of dabigatran

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004357-13-DK

Enrollment

Unknown

Registered

2015-02-24

Start date

2015-03-18

Completion date

Unknown

Last updated

2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation MedDRA version: 17.1 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849

Interventions

Trade Name: Pradaxa Pharmaceutical Form: Capsule INN or Proposed INN: DABIGATRAN CAS Number: 211914-51-1 Current Sponsor code: CTH201401 Concentration unit: mg milligram(s) Concentration type: range

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with atrial fibrillation Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To investigate the effects of dabigatran on measurements of platelet function ;Secondary Objective: 2. To investigate the effect of dabigatran on other laboratory parameters 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	—

Measure

Time frame

Main Objective: 1. To investigate the effects of dabigatran on measurements of platelet function ;Secondary Objective: 2. To investigate the effect of dabigatran on other laboratory parameters 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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactDepartment of Clinical Biochemistry

Odense University Hospital

ode.kbf@rsyd.dk0045 65412821

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026