Trial document




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  DRKS00003157

Trial Description

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Title

Effect of daBIGatran and rivaROXaban on Platelets

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Trial Acronym

BIG-ROX-P

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this observational study, the effect of dabigatran and rivaroxaban on platelets will be evaluated.

Patients with atrial fibrillation after stent implantation due to coronary heart disease receive medications that prevent potentially life-threatening blood clots. These recommendations are not based on the results of large clinical trials but on expert opinions. Generally, phenprocoumon is combined with platelet inhibitors. In patients with atrial fibrillation treatment with warfarin is partly replaced by new anticoagulants (dabigatran and rivaroxaban).
In this observational study the platelet function in patients with atrial fibrillation who receive dabigatran or rivaroxaban will be evaluated. This is a condition for a future study concerning the combination of the new oral anticoagulants (dabigatran and rivaroxaban) with platelet inhibitors in patients with atrial fibrillation after stent implantation.

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Brief Summary in Scientific Language

Atrial fibrillation (AF) is the most common cardiac arrhythmia requiring therapy and is associated with risk for cardiac embolism. Patients with moderate to high risk for cerebral thromboembolic complication (CHADS2 score of 1 = moderate risk,> 1 = high risk) are treated according to guideline with vitamin K antagonists (VKA).1 For most patients with AF permanent oral anticoagulation (OAC) is recommended even after cardioversion. VKA have a narrow therapeutic index and thus require frequent and careful monitoring. Direct FXa antagonists (eg rivaroxaban) or direct thrombin-antagonists (eg dabigatran) could replace VKA for the indication AF at least partially. In November 2010, in the preliminary results of the ROCKET-AF study rivaroxaban showed non-inferiority to VKA.2 In the RE-LY study dabigatran was superior to VKA.3 The EU approval for dabigatran and rivaroxaban for patients with AF is expected this year. For prophylaxis of deep vein thrombosis (DVT), these substances were approved already.4-7 Dabigatran and rivaroxaban are used in clinical practice in contraindications to standard therapy with VKA (for example, stroke, intracerebral hemorrhage, unstable INR, incompliance).
In this non-interventional study the effect of dabigatran and rivaroxaban on platelet function will be investigated in order to detect possible functional interactions with antiplatelet agents. This is required as a condition for a randomized controlled trial of the combination of dual antiplatelet therapy (ASA and clopidogrel) and direct oral anticoagulants in patients with atrial fibrillation after stent implantation.
1. Lip GY, Lim HS. Atrial fibrillation and stroke prevention. Lancet Neurol 2007;6:981-93.
2. Cleland JG, Coletta AP, Buga L, et al. Clinical trials update from the American Heart Association Meeting 2010: EMPHASIS-HF, RAFT, TIM-HF, Tele-HF, ASCEND-HF, ROCKET-AF, and PROTECT. Eur J Heart Fail;13:460-5.
3. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
4. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765-75.
5. Kakkar AK, Brenner B, Dahl OE, et al. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008;372:31-9.
6. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009;373:1673-80.
7. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008;358:2776-86.

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Organizational Data

  •   DRKS00003157
  •   2011/07/13
  •   [---]*
  •   yes
  •   Approved
  •   182/11, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I48.19 -  [generalization I48: Atrial fibrillation and flutter]
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Interventions/Observational Groups

  •   Patients with first detected atrial fibrillation usually have an indication for OAC. After the physicians´ decision for a long-term treatment with dabigatran or rivaroxaban venous blood will be collected to assess platelet function. A second venous blood collection and platelet function assessment takes place after medication with dabigatran or rivaroxaban, respectively.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

change (Δ) of platelet aggregation assessed by light transmittance aggregometry (LTA) before and after medication.

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Secondary Outcome

change (Δ) of platelet function assessed by Multiplate, VerifyNow and platelet biomarkers before and after medication.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/09/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

first detected AF and OAC with dabigatran or rivaroxaban, informed consent

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Exclusion Criteria

difficult venous puncture

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Addresses

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    • Universitätsklinikum Freiburg Innere Medizin 3
    • Mr.  Dr.  Christoph  Olivier 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Innere Medizin 3
    • Mr.  Dr.  Christoph  Olivier 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Innere Medizin 3
    • Mr.  Dr.  Christoph  Olivier 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.