DABI-ADP-1:IMPACT OF DABIGATRAN AND PHENPROCOUMON ON ADP INDUCED PLATELET AGGREGATION IN PATIENTS WITH ATRIAL FIBRILLATION - DABI-ADP-1

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen0 个研究点目标入组 70 人开始时间: 2011年2月18日最近更新: 2012年10月16日

适应症

试验速览

暂无简介。

•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

•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 <30ml/min)
•10. Moderate or severe hepatic impairment (Child-Pugh class B or C) or with elevated hepatic transaminases >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 < 10 g/dL; platelet count < 100 x 109 cells/L or platelet count > 600 x 109 cells/L
•15. Previous enrollment in this trial
•16. Patient’s inability to fully comply with the study protocol

发起方

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen