Patients with atrial fibrillation and in indication for oral anticoagulation, who are currently receiving additionally clopidogrel for another medical condition, such as acute coronary syndrome and/or coronary/carotid/peripheral stent implantation. MedDRA version: 14.1 Level: LLT Classification code 10068617 Term: Coronary heart disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 1000
Conditions
Interventions
Trade Name: Pradaxa
Product Name: Pradaxa
Pharmaceutical Form: Capsule
INN or Proposed INN: DABIGATRAN ETEXILATE
CAS Number: 211915-06-9
Concentration unit: mg/g milligram(s)/gram
Concentration number
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 = 1.6 at study entry 3. Current clopidogrel treatment 4. 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, Ketoconazole, Amiodarone, Chinidin, Rifampicin, St. John's wort (Johanniskraut), Verapamil or Carbamazepine 4. INR > 1.6 5. Patients with a recent thrombembolic event (severe disabling stroke in the last 6 months or any stroke in the last 14 days) and/or high thrombembolic risk (mechanical valve, pulmonary embolism, deep vein thrombosis or LV thrombus) requiring bridging therapy with either unfractionated heparin or LMWH 6. Contraindication for oral anticoagulation 7. Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; 8. Severe renal insufficiency (Creatinine Clearance 2 times the upper limit of normal 10. Planned major surgery within the next 2 weeks with the need to discontinue antithrombotic therapy 11. Known allergy or intolerance to the study medications and their ingredients: dabigatran (GelborangeS), phenprocoumon 12. Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a pregnancy test is mandatory) 13. Relevant hematologic deviations: hemoglobin 600 x 109 cells/L 14. Previous enrollment in this trial 15. Patient’s inability to fully comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 14 day after initiation of therapy.;Main Objective: The primary hypothesis to be tested is whether dabigatran is superior to phenprocoumon in the reduction of clopidogrel mediated 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 14 day 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 | — |
Countries
Germany
Outcome results
None listed