DABI-ADP-2:IMPACT OF DABIGATRAN AND PHENPROCOUMON ON CLOPIDOGREL MEDIATED ADP INDUCED PLATELET AGGREGATION IN PATIENTS WITH ATRIAL FIBRILLATION - DABI-ADP-2

• Conditions: 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: 14.1Level: LLTClassification code 10068617Term: Coronary heart diseaseSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 10047065 - Vascular disorders

• Registration Number: EUCTR2011-000504-18-DE
• Lead Sponsor: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-21
• Last Update Posted: 5 August 2014

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 = 1.6 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

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 <30ml/min)
9. Moderate or severe hepatic impairment (Child-Pugh class B or C) or with elevated hepatic transaminases >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 < 10 g/dL; platelet count < 100 x 109 cells/L or platelet count > 600 x 109 cells/L
14. Previous enrollment in this trial
15. 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
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.<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 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))<br>2. Coagulation parameters (aPTT, INR, Thrombin coagulation Time)<br>3. Dabigatran Plasmalevels <br>