TWILIGHT study is a multicenter RCT comparing treatment with ticagrelor alone versus ticagrelor plus aspirin in high-risk patients after PCI. All patients will receive DAPT (ticagrelor plus aspirin) for the initial 3 months post-PCI and then be randomized to either Ticagrelor alone OR Ticagrelor plus Aspirin DAPT.

To investigate the pharmacodynamic effects of the two treatments in this trial, a 'Platelet Sub-study' will be conducted only at the Mount Sinai Medical Center. The sub-study will recruit randomized patients from the TWILIGHT Trial at Mount Sinai and conduct specialized blood tests at randomization and one month thereafter. The aim of the Platelet Sub-study is to compare the antithrombotic effects of Ticagrelor alone versus Ticagrelor plus Aspirin using an ex vivo model of thrombosis (Badimon Chamber).

• Coronary Artery Disease
• Myocardial Infarction

• Drug: Ticagrelor
  90mg tablet bid for 12 months
• Drug: ASA
  enteric coated aspirin 81mg-100mg daily p.o. for 12 months

• Ticagrelor
  Ticagrelor 90mg tablet bid for 12 months
  Intervention: Drug: Ticagrelor
• Ticagrelor + ASA
  Ticagrelor 90mg tablet bid for 12 months and enteric coated aspirin 81mg-100mg daily p.o. for 12 months
  Interventions:

  • Drug: Ticagrelor
  • Drug: ASA

Inclusion Criteria:

Patients enrolled in the TWILIGHT trial:

Clinical Inclusion Criteria (must meet at least one):

• Adult patients ≥ 65 years of age
• Troponin (+) acute coronary syndrome
• Female gender
• Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
• Diabetes mellitus treated with medications (oral hypoglycemic, subcutaneous injection of insulin)
• Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 or creatinine clearance (CrCl) < 60 ml/min

Angiographic Inclusion Criteria (must meet at least one):

• Multivessel coronary artery disease
• Target lesion requiring total stent length >30 mm
• Thrombotic target lesion(s)
• Bifurcation lesions with Medina X,1,1 classification requiring at least 2 stents
• Left main (≥50%) or proximal LAD (≥70%) lesion
• Calcified target lesion(s) requiring atherectomy

Exclusion Criteria:

Patients not eligible to participate in the TWILIGHT trial:

• Under 18 years of age
• Contraindication to aspirin
• Contraindication to ticagrelor
• Planned surgery within 90 days
• Planned coronary revascularization (surgical or percutaneous) within 90 days
• Need for chronic oral anticoagulation
• Prior stroke
• Dialysis-dependent renal failure
• Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
• Emergent or salvage PCI or STEMI presentation.
• Liver cirrhosis
• Life expectancy < 1 year
• Unable or unwilling to provide informed consent
• Women of child bearing potential (as determined by hospital standard of care)
• Fibrinolytic therapy within 24 hours of index PCI
• Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
• Platelet count < 100,000 mm3
• Requiring ongoing treatment with aspirin > 325 mg daily.