Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The recommended antiplatelet treatment regimen for patients affected by acute coronary
      syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in the
      combination of aspirin and a P2Y12 receptor inhibitor. More potent P2Y12 receptor inhibitors,
      such as ticagrelor, have been developed which are associated with less response variability
      than clopidogrel and better clinical outcomes. Ticagrelor use has increased significantly
      because of its more expanded Food and Drug Administration (FDA) indications compared with
      prasugrel. However, despite the evidence for sustained efficacy and safety, many physicians
      limit treatment duration with ticagrelor to the early phases following an ACS mostly due to
      cost issues and concerns about increased bleeding. Therefore, it is very common in clinical
      practice to switch patients while on maintenance dosing (MD) with ticagrelor to treatment
      with clopidogrel. However, the pharmacodynamic (PD) effects of switching from ticagrelor to
      clopidogrel remain unknown. Therefore, the aim of this investigation is to evaluate the PD
      effects of switching from ticagrelor to clopidogrel.
    

Detailed description: 
      The recommended antiplatelet treatment regimen for patients affected by acute coronary
      syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in the
      combination of aspirin and a P2Y12 receptor inhibitor. Currently, three P2Y12 receptor
      inhibitors are available for clinical use (clopidogrel, prasugrel, and ticagrelor). Among
      these, clopidogrel remains the most widely used. However, recent studies have shown that
      there is a broad variability in platelet-inhibitory response induced by clopidogrel, which in
      turn is associated with worse outcomes. More potent P2Y12 receptor inhibitors (prasugrel and
      ticagrelor) have been developed which are associated with less response variability than
      clopidogrel and better clinical outcomes. Ticagrelor use has increased significantly because
      of its more expanded Food and Drug Administration (FDA) indications compared with prasugrel.
      However, despite the evidence for sustained efficacy and safety, many physicians limit
      treatment duration with ticagrelor to the early phases following an ACS (early weeks or
      months, rather than one-year) mostly due to cost issues and concerns about increased
      bleeding. Therefore, it is very common in clinical practice to switch patients while on
      maintenance dosing (MD) with ticagrelor to treatment with clopidogrel. However, the
      pharmacodynamic (PD) effects of switching from ticagrelor to clopidogrel remain unknown. In
      addition, it is unknown whether switching from ticagrelor to clopidogrel should occur with or
      without a loading dose (LD). Therefore, the aim of this investigation is to evaluate the PD
      effects of switching from ticagrelor to clopidogrel with and without a LD. The present study
      has a prospective, randomized, open-label design, in which patients will be treated with 4
      different strategies to assess PD profiling after switching. This study will provide
      important insights on PD effects of switching from ticagrelor to clopidogrel.
    

Intervention name(s): Clopidogrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Swiching from ticagrelor to clopidogrel; Continue treatment with ticagrelor
Other intervention name(s): Plavix; Brilinta
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment