Patients with atrial fibrillation and an indication for oral anticoagulation. MedDRA version: 13.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Pradaxa
Product Name: Pradaxa
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DABIGATRAN ETEXILATE
CAS Number: 211915-06-9
Concentration unit: mg/g milligram(s)/gram
Concentration
Sponsors
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with atrial fibrillation and an indication for oral anticoagulation (CHA2DS2-VASc score= 1). 2. INR = 1.3 at study entry 3. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age =18 years 2. Cardiogenic shock 3. Current therapy with dabigatran 4. INR > 1.3 5. Patients with a recent thrombembolic event and high thrombembolic risk requiring bridging therapy with either unfractionated heparin or LMWH 6. Current, recent (2 weeks) or expected (1 week) clopidogrel therapy 7. Contraindication for oral anticoagulation 8. Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; 9. Severe renal insufficiency (Creatinine Clearance 2 times the upper limit of normal 11. Planned major surgery within the next week with the need to discontinue antithrombotic therapy 12. Known allergy or intolerance to the study medications: dabigatran, phenprocoumon 13. Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a pregnany test is mandatory) 14. Relevant hematologic deviations: hemoglobin 600 x 109 cells/L 15. Previous enrollment in this trial 16. Patient’s inability to fully comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary hypothesis to be tested is whether dabigatran is superior to phenprocoumon in the reduction of ADP induced platelet aggregation. The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on day 14 after initiation of therapy.;Secondary Objective: 1. Platelet function tests ( ADPtest HS (MEA) 6.4µmol/l ADP in the presence of 9.4 nmol/l prostaglandin E1, TRAP-6 (32µmol/l), Collagen (3.2µg/ml collagen (COLtest)) 2. Coagulation parameters (aPTT, INR, Thrombin coagulation Time) 3. Dabigatran Plasmalevels ;Primary end point(s): The primary end point of the study is the peak level of maximal ADP(6,4 µM)-induced platelet aggregation measured by MEA, on day 14 after initiation of therapy. | — |
Countries
Germany
Outcome results
None listed