Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery
Condition: Coronary Artery Bypass; Antiplatelet Agents
Intervention: Aspirin; Ticagrelor
Intervention MeSH terms: Aspirin; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CABG; Antiplatelet; Ticagrelor

Summary:

      The study population will include all patients undergoing elective CABG. Consent and
      randomization will occur before surgery. Total 500 patients undergoing elective CABG will be
      randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this
      open-label study. All the enrolled patients will stop oral antiplatelet drugs according to
      local protocol before the surgery. Within the first 24 hours after surgery, study medication
      should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs
      by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving
      ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs
      by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients
      will undergo a multislice computed tomography angiography to assess vein graft patency.

      This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as
      compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of
      vein graft patency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients able to provide written informed consent

          -  Provision of informed consent prior to any study specific procedures

          -  Female and male patients aged 18-80 years

          -  Indication for CABG surgery

        Exclusion Criteria:

          -  Cardiogenic shock, haemodynamic instability

          -  Need for urgent revascularization within 5 days from presentation

          -  Single vessel disease

          -  Two vessel disease with normal left ventricular function (> 50%)

          -  Need for concomitant other cardiac surgery (e.g. valve replacement)

          -  Need for dual antiplatelet treatment for the patients undergoing CABG after acute
             coronary syndrome(ACS)

          -  Contraindication for aspirin and ticagrelor use(e.g. known allergy)

          -  History of bleeding diathesis within 3 months prior presentation

          -  History of significant GI bleed within 1 year prior presentation

          -  History of peptic ulcer without GI bleeding in past 3 years

          -  History of intracranial hemorrhage

          -  History of moderate to severe liver impairment

          -  Patient requires dialysis

          -  Patient with an increased risk of bradycardic events (as patients without a pacemaker
             who have sick sinus syndrome, 2nd or 3rd degree arteriolar-venular block or
             bradycardic-related syncope)

          -  Need vitamin K antagonist therapy after bypass surgery eg. persistent atrial
             fibrillation, mechanical valves

          -  Known, clinically important thrombocytopenia(i.e. < 100*109/L)

          -  Known, clinically important anaemia (i.e. <100g/L)

          -  Participation in another investigational drug or device study in the last 30 days

          -  Pregnancy or lactation(for premenopausal women 2 methods of reliable contraception,
             one of which must barrier method, are required)

          -  Concomitant oral or intravenous therapy with strong cytochrome P450 3A4(CYP3A4)
             inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4
             inducers which cannot be stopped for the course of the study (strong inhibitors:
             ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone,
             ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of
             grapefruit juice. Substrates with narrow therapeutic index: cyclosporine, quinidine.
             Strong inducers: rifampin, phenytoin, carbamazepine. )

          -  Any other condition such as active cancer

          -  Life expectancy less than 12 months that may result in protocol non-compliance or a
             risk for being lost to follow up

          -  Indication for major surgery(e.g. cancer treatment, carotid surgery, cerebral surgery,
             major vascular surgery)