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Table 2 Study inclusion and exclusion criteria

From: PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor (PREDICT): study rationale and design. A randomized multicenter clinical trial using intracoronary multimodal physiology

Inclusion criteria

 Subject with type 2 diabetes mellitus or pre-type 2 diabetes mellitus statusa

 Subject must be older than 18 years

 Written informed consent available

 Documented silent ischemia, stable angina or patient who is scheduled for elective revascularization

 Subject is eligible for PCI, and PCI target(s) have FFR ≤0.80

Exclusion criteria

 Prior myocardial infarction in the territory of the target vessel

 Akinesia or dyskinesia in subtended myocardial segments

 Severe impairment of left ventricular function (LVEF <35%)

 PCI target is a chronic total occlusion

 Target lesion has been treated previously (restenotic lesions)

 Target vessel is a saphenous vein graft or a surgical graft has been anastomosed to the target vessel

 TIMI flow ≤1 prior to guide wire crossing

 Subject is not eligible for treatment with drug eluting stent

 Bleeding disorders or chronic anticoagulant treatment

 Left main stenosis >50%

 Coronary surgery deemed more beneficial for the patient than PCI

 Ongoing treatment with Ticagrelor

 Intolerance or contraindications to anti-platelet drugs

 Contraindications for adenosine administration

 Platelet count <75,000 or >700,000/mm3

 Pregnant or breast feeding patient

 History of intracranial hemorrhage

 Severe hepatic impairment

  1. FFR Fractional Flow Reserve, LVEF Left Ventricular Ejection Fraction, PCI percutaneous coronary intervention, TIMI thrombolysis in myocardial infarction
  2. a2014 American Diabetes Association definition [41]