Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Clopidogrel; Ticagrelor
Intervention description: Swiching from ticagrelor to clopidogrel; Continue treatment with ticagrelor
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients with angiographically documented CAD

          2. On therapy with aspirin(<100mg/day) and clopidogrel (75mg/day) for at least 30 days
             per standard of care

          3. Age between 18 and 80 years old

        Exclusion Criteria

          1. History of intracranial bleeding

          2. Severe hepatic impairment (ALT >2.5 times the upper limit of normal)

          3. Active bleeding or propensity to bleed or blood dycrasia

          4. Platelet count <80x106/mL

          5. Hemoglobin <10g/dL

          6. Hemodynamic instability

          7. Estimated glomerular filtration rate (eGFR) <30 mL/min

          8. On treatment with oral anticoagulants

          9. Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker
             protection

         10. Drugs interfering CYP3A4 metabolism (to avoid interaction with ticagrelor):
             ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir,
             saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin

         11. Pregnant females [women of childbearing age must use reliable birth control (i.e. oral
             contraceptives) while participating in the study].