Effect of Diabetes and Hepatic Enzymes Mutation on Clopidogrel VS Ticagrelor Activity in Myocardial Infarction (MI) Patients Undergoing Primary Percutaneous Coronary Intervention (PCI)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational [Patient Registry]

Summary: 
      In this study the combined effect of diabetes mellitus and cyp2c19 polymorphism on platelet
      aggregation inhibitory activity of the highest traditionally used loading dose 600 mg
      clopidogrel and ticagrelor 180 mg loading dose will be compared in acute coronary syndrome
      (ACS) patients undergoing PCI.
    

Detailed description: 
      Study subjects Inclusion criteria Diabetic patients (well-controlled type 2 diabetes
      mellitus) and non-diabetic patients with anterior ST-elevation and non-st elevation
      myocardial infarction undergoing PCI.

      Exclusion criteria Patients who are with a family or personal history of bleeding. Patients
      with platelet count less than 100 x 103/ul. Patients with known hypersensitivity to
      clopidogrel or ticagrelor. Patients with serious bleeding tendency, history of intracranial
      hemorrhage, a sign of active bleeding, uncontrolled hypertension.

      Patients with severe liver disorders

      Methods The study will be conducted in the cardiac intensive care unit at Assiut educational
      hospital of cardiovascular diseases.

        -  diabetic and non-diabetic patients with ST-elevation and non-ST elevation myocardial
           infarction undergoing PCI will be enrolled in this study.

        -  At baseline, all patients will undergo full clinical examination and laboratory
           diagnostic tests. Current and previous medical history and medication history will be
           thoroughly investigated.

      Recruited patients will be classified into two groups. One group will receive 600 mg loading
      dose clopidogrel before PCI and 75 mg daily maintenance dose. The other group of patients
      will receive 180 mg loading dose ticagrelor before PCI and 90 mg twice daily maintenance
      dose.

      A blood sample of will be withdrawn from each patient to undergo genotypic testing using Real
      Time polymerase chain reaction (PCR) to detect polymorphism in the cyp2c19 enzyme.

        -  Clopidogrel and ticagrelor antiplatelet activity will be assessed by estimating the
           maximum platelet aggregation (MPA) using light transmittance platelet aggregometry and
           platelet reactivity index (PRI) using whole-blood vasodilator-stimulated phosphoprotein
           (VASP) measured by quantitative flow cytometry.

        -  All patients will be followed-up for at least three to six months month by clinic visits
           and phone calls to detect acute and subacute stent thrombosis, acute cardiac events,
           revascularization and cardiovascular death after PCI.

      Study endpoints Acute stent thrombosis 24 hours after PCI and sub-acute stent thrombosis
      within 30 days after PCI, cardiovascular death, recurrent acute cardiac events, recurrent
      unstable anginal pain and hospitalization for cardiovascular diseases.
    

Intervention name(s): Clopidogrel; Ticagrelor 90mg
Intervention type(s): Drug; Drug
Intervention description(s): 8 tablets 75 mg clopidogrel loading dose before PCI; 2 tablets 90 mg brilique before PCI
Other intervention name(s): plavix; brilique
Intervention MeSH terms: Clopidogrel; Ticagrelor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic and non-diabetic patients with ST-elevation elevation and non-ST elevation
        myocardial infarction undergoing PCI.
      
Biospecimen description: 
      Blood samples.