Low Maintenance Dose Ticagrelor Versus Clopidogrel in Diabetes Patients Undergoing PCI

Exclusion Criteria

• •1. Previous MI (with the exception of definite non-type 1 MI \[eg, due to coronary revascularization procedure, profound hypotension, hypertensive emergency, tachycardia, or profound anemia\])
• •2. Previous stroke (transient ischemic attack \[TIA\] is not included in the stroke definition)
• •3. Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI
• •4. On treatment with clopidogrel, prasugrel, or ticagrelor due to a prior acute major CV event (MI or stroke) (on treatment with clopidogrel due to prior vascular intervention not secondary to a major CV event is allowed)
• •5. Planned use of aspirin treatment at doses \>100 mg od
• •6. Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study:
• •* Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir
• •* CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses \>40 mg daily or lovastatin at doses \>40 mg daily
• •7. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses)
• •8. Patients with known bleeding diathesis or coagulation disorder
• •9. History of previous intracerebral bleed at any time, gastrointestinal (GI) bleed within the past 6 months prior to randomization, or major surgery within 30 days prior to randomization
• •10. Active pathological bleeding
• •11. Hypersensitivity to ticagrelor and clopidogrel or any of the excipients
• •12. Increased risk of bradycardic events (eg, known sick sinus syndrome, second or third degree AV block or previous documented syncope suspected to be due to bradycardia) unless treated with a pacemaker
• •13. Known severe liver disease (eg, ascites and/or clinical signs of coagulopathy)
• •14. Renal failure requiring dialysis
• •15. Known platelet count \<80x106/mL
• •16. Known hemoglobin \<9 g/dL
• •17. Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding. If a subject becomes pregnant during the course of the study the investigational product should be discontinued immediately \[the outcome of all pregnancies (spontaneous miscarriage, elective termination, ectopic pregnancy, normal birth or congenital abnormality) will be followed up and documented even if the subject was discontinued from the study\].
• •18. Inability of the patient to understand and/or comply with study procedures and/or follow up, in the opinion of the investigator, OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
• •19. Life expectancy of less than 1 month based on investigator's judgement
• •20. Participation in another clinical study with an investigational (defined as non-FDA approved) product within 28 days prior to enrolment
• •21. Previous randomization in the present study