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

• Conditions: Patients with atrial fibrillation and an indication for oral anticoagulation.; MedDRA version: 13.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2011-000503-40-DE
• Lead Sponsor: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-18
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary hypothesis to be tested is whether dabigatran is superior to phenprocoumon in the reduction of ADP induced platelet aggregation.<br>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))<br>2. Coagulation parameters (aPTT, INR, Thrombin coagulation Time)<br>3. Dabigatran Plasmalevels <br>;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.