EUCTR2011-000503-40-DEActive, not recruitingNot Applicable
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 sites70 target enrollmentStarted: February 18, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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