Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and
      randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48
      hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which
      time they will receive telephone follow-up one and nine months following CABG and clinic
      visits three, six, and twelve months following CABG.
    

Detailed description: 
      Patients will be screened for eligibility pre-CABG, and informed consent signed before
      randomization. Aspirin 81mg/d will be started within 12 hours of CABG as per routine
      practice. Study medication will be started within 48 hours after CABG if there are no
      contraindications. Patients will be randomized to ticagrelor 90mg bid (no loading dose) or
      placebo bid for 1 year following CABG. Aspirin 81mg/d will be continued for at least 1 year
      post-CABG. Other cardiac medications will be at the discretion of the treating physicians as
      per standard practice.

      Patients will be followed daily during their hospital stay. Outpatient visits will be
      scheduled at 3, 6 and 12 months. There will also be telephone contacts at 1 and 9 months.

      CT Substudy:Patients in the CT angiography substudy(the first 240 enrolled subjects) will
      have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-up.Grafts will
      be separately evaluated based upon the conduits used, internal mammary, radial, or saphenous
      vein grafts. Graft patency is defined as contrast filling of the conduit and the coronary
      artery beyond the anastomosis. Grafts with ≥50% stenosis will also be recorded. The location
      of the stenosis will also be recorded (proximal anastomosis, body of graft, or distal
      anastomosis). CT angiograms will be evaluated by 2 interpreters (radiologists or
      cardiologists) blinded to the randomized treatment, and will be reviewed by a 3rd interpreter
      if there are disagreements. If no consensus could be reached among the 3 interpreters, the
      graft will be deemed not analyzable, or be subject to invasive coronary angiography for
      definitive assessment if clinically indicated.

      The primary efficacy endpoint is the composite of all-cause mortality, MI, stroke, or repeat
      revascularization within 1 year following CABG. Secondary endpoints include the individual
      endpoints of all-cause mortality, cardiovascular death, MI, stroke, repeat revascularization.
    

Intervention name(s): ticagrelor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ticagrelor 90 mg BID for 90 days; Placebo 1 pill BID for 90 days
Other intervention name(s): Brilinta
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: CABG; Ticagrelor; Coronary Artery Bypass Surgery