Platelet Inhibition of Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients After Elective Percutaneous Coronary Intervention

Exclusion Criteria

• •1. Patients who had acute coronary syndrome (ACS) within 12 months of screening.
• •2. Occurrence of myocardial infarction (MI) related to index elective PCI (type 4a MI) or myocardial infarction related to stent thrombosis (type 4b MI) according to the Third Universal Definition of Myocardial Infarction.
• •3. Use of parenteral antithrombotic agents, e.g., glycoprotein IIb/IIIa inhibitors (GPIs), bivalirudin, unfractionated heparin, enoxaparin or fondaparinux within 24 hours of screening.
• •4. Use of any oral antithrombotic agents, with the exception of Clopidogrel and ASA, within 30 days of screening.
• •5. Any other indications (e.g., atrial fibrillation, prosthetic heart valve, venous thromboembolism, ventricular thrombosis, et al) for antithrombotic treatment other than ASA 100 mg daily, Clopidogrel and Ticagrelor during study period.
• •6. Concomitant therapy with moderate or strong cytochrome P-450 (CYP) 3A inhibitors, CYP 3A substrates with narrow therapeutic index, or strong CYP 3A inducers during study period.
• •7. Concomitant therapy with moderate or strong CYP 2C19 inhibitors, CYP 2C19 substrates with narrow therapeutic index, or strong CYP 2C19 inducers during study period.
• •8. Increased bleeding risk including:
• •* recent (within 30 days of screening) gastrointestinal (GI) bleeding;
• •* any history of intracranial, intraocular, retroperitoneal, or spinal bleeding;
• •* recent (within 30 days of screening) major trauma or major surgery;
• •* sustained uncontrolled hypertension (systolic blood pressure \[SBP\] \> 180 mmHg or diastolic blood pressure \[DBP\] \> 100 mmHg);
• •* history of hemorrhagic disorders that can increase the risk of bleeding, e.g., haemophilia, von Willebrand's disease;
• •* inability to discontinue required concomitant therapy with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) at screening;
• •* platelet count less than 100,000/mm3 or hemoglobin \< 10 g/dL.
• •9. Contraindication or other reason that ASA, Clopidogrel, or Ticagrelor should not be administered (e.g., hypersensitivity, active bleeding \[including active pathological bleeding\], any bleeding tendency \[coagulation defects\], moderate and severe hepatic impairment, risk of bradycardia, chronic obstructive pulmonary disease, chronic or active asthma, hyperuricemia, gout, etc.).
• •10. History of intolerance to ASA, Clopidogrel or Ticagrelor.
• •11. Patients that are scheduled for CABG during the study period.
• •12. Patient requires dialysis or has a creatinine clearance (Clcr) \< 30 mL/min as calculated by the Cockcroft-Gault equation: Clcr = (140 - Age) × WT / (72 × Scr) (× 0.85 for females), where WT is weight in kg, Scr is serum creatinine in mg/dL.
• •13. Any acute or chronic unstable conditions in the past 30 days or other conditions which, in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g., active cancer, risk for non-compliance, risk for being lost to follow-up).
• •14. Participation in another investigational drug or device study within 30 days of screening.
• •15. Involvement in the planning and conduct of the study (applies to investigators, contract research organization staff, and study site staff).
• •16. History of drug addiction or alcohol abuse in the previous 2 years.
• •17. Recent (within 30 days of screening) blood donation.
• •18. Known pregnancy, breast-feeding, or intend to become pregnant during the study period.