E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atrial fibrillation |
Atrie flimmer |
|
E.1.1.1 | Medical condition in easily understood language |
Irregular heart rhytm |
uregelmæssig hjerterytme |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071667 |
E.1.2 | Term | Persistent atrial fibrillation |
E.1.2 | System Organ Class | 100000004849 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To investigate the effects of dabigatran on measurements of platelet function
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E.2.2 | Secondary objectives of the trial |
2. To investigate the effect of dabigatran on other laboratory parameters
3. Describe the effect of atrial fibrillation on platelets |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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|
E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Extent of thrombin receptor activating peptide induced platelet aggregation |
|
E.5.1.1 | 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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E.5.2 | 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 |
|
E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Patienterne som egne kontroller (før og efter opstart med dabigatran) |
Patients are their own control (before and after starting dabigatran treatment) |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |