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Trial record 39 of 335 for:    DABIGATRAN

Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation (Dabi-ADP-1)

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ClinicalTrials.gov Identifier: NCT01339819
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Tracking Information
First Submitted Date  ICMJE April 15, 2011
First Posted Date  ICMJE April 21, 2011
Last Update Posted Date July 2, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
ADP induced platelet aggregation [ Time Frame: 2 weeks ]
To determine whether there are differences in ADP induced platelet aggregation after 2 weeks in patients receiving dabigatran or phenprocoumon.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01339819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
  • Platelet function tests [ Time Frame: 2 weeks ]
    ADPtest HS (MEA) , TRAP, Collagen
  • Coagulation parameters [ Time Frame: 2 weeks ]
    aPTT, INR, Thrombin coagulation time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation
Official Title  ICMJE Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation
Brief Summary The aim of this study is to evaluate whether Dabigatran itself reduces ADP induced platelet aggregation measured by MEA as compared to Phenprocoumon after a two-week treatment with either agent.
Detailed Description

Oral anticoagulation with vitamin K antagonists (OAC) is the standard care for reducing stroke in patients with atrial fibrillation. Just recently the direct, competitive thrombin inhibitor dabigatran has been approved by the FDA for stroke prevention in patients with atrial fibrillation. In a large multicenter trial it was shown that dabigatran was at least as effective as Vitamin K antagonists in the prevention of stroke without an increase of major hemorrhage.

Approximately 6 % of patients who undergo coronary stenting and need DAT with aspirin and clopidogrel need in addition OAC for the reduction of cardiac, cerebral and systemic thromboembolic events. These patients will therefore need triple therapy, a therapy which is associated with increased bleeding complications. Although phenprocoumon given solely without clopidogrel has no impact on ADP induced platelet aggregation, it has been shown that phenprocoumon significantly attenuates the antiplatelet effects of clopidogrel.

ADP induced platelet aggregation measured with multiple electrode platelet aggregometry (MEA) is a marker for the efficacy of the clopidogrel therapy and (i) a low response (AUC ≥ 468) to clopidogrel has been associated with an increase of ischemic events such as stent thrombosis and (ii) patients with an enhanced response to clopidogrel (AUC ≤ 188) have higher bleeding rates.

It is therefore crucial to evaluate whether an additional antithrombotic therapy such as dabigatran alters ADP induced platelet aggregation in these patients. While it has been shown that intravenous administration of the direct thrombin inhibitor bivalirudin further reduces ADP induced platelet aggregation in patients on clopidogrel therapy, it is unknown whether dabigatran has also an impact on ADP induced platelet aggregation.

To evaluate the impact of dabigatran on ADP induced platelet aggregation we will randomize patients with atrial fibrillation and the need for oral anticoagulation for a two-week treatment with either dabigatran or phenprocoumon and we hypothesize that dabigatran is superior to phenprocoumon in the reduction of ADP induced platelet aggregation. Patients who are concomitantly treated with clopidogrel are being studied in a different trial with a similar study design (Dabi ADP-2).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Dabigatran
    Patients assigned to this group will receive Dabigatran
    Other Name: Pradaxa
  • Drug: Phenprocoumon
    Patients assigned to this group will receive Phenprocoumon
    Other Name: Marcumar
Study Arms  ICMJE
  • Experimental: Arm 1
    Dabigatran Therapy
    Intervention: Drug: Dabigatran
  • Active Comparator: Arm 2
    Phenprocoumon Therapy
    Intervention: Drug: Phenprocoumon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2011)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Patients with atrial fibrillation and an indication for oral anticoagulation (CHA2DS2-VASc score≥ 1).
  • Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

Key Exclusion Criteria:

  • Age ≤18 years
  • Cardiogenic shock
  • Current therapy with dabigatran
  • Current, recent (2 weeks) or expected (1 week) clopidogrel therapy
  • Contraindication for oral anticoagulation
  • Active bleeding
  • Known allergy or intolerance to the study medications: dabigatran, phenprocoumon
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01339819
Other Study ID Numbers  ICMJE GE IDE No. A01611
2011-000503-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deutsches Herzzentrum Muenchen
Study Sponsor  ICMJE Deutsches Herzzentrum Muenchen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
PRS Account Deutsches Herzzentrum Muenchen
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP