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Table 1 Enrollment criteria

From: Harmonizing Optimal Strategy for Treatment of coronary artery diseases – comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial

General inclusion criteria

 1. Subject must be ≥ 18 years

 2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving percutaneous coronary intervention and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

 3. Subject must have a culprit lesion in a native coronary artery with significant stenosis (>50 % by visual estimate) eligible for stent implantation

 4. Subject must have clinical diagnosis of acute coronary syndrome that includes unstable angina (crescendo, new-onset, resting) and myocardial infarction

Exclusion criteria

The following patients will be enrolled in stent comparison, but excluded from antiplatelet prasugrel comparison. They will be classified as antiplatelet observational cohort:

  1. Subjects ≥ 75 years

  2. Body weight < 60 kg

  3. History of TIA or stroke

 1. The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus, everolimus, contrast media (patients with documented sensitivity to contrast media (e.g. rash) who can be effectively premedicated with steroids and diphenhydramine] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled)

 2. Patients with active pathologic bleeding

 3. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months

 4. Systemic (intravenous) biolimus, or everolimus use within 12 months

 5. Woman of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study

 6. History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions

 7. Non-cardiac co-morbid conditions are present with life expectancy < 1 year or that may result in protocol non-compliance (per site investigator’s medical judgment)

  1. TIA transient ischemic attack