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. 2020 Aug 26;10(8):e038074. doi: 10.1136/bmjopen-2020-038074

Table 1.

Inclusion and exclusion criteria

Exclusion criteria
  • Patients who meet all the following requirements.

  • Patients diagnosed with coronary heart disease who met at least one of the following diagnostic criteria1: (1) a clear history of myocardial infarction; (2) prior coronary revascularisation; (3) coronary angiography or coronary angiography suggesting at least one coronary artery stenosis with catheter stenosis ≥50%; (4) cardiac MRI or radionuclide myocardial perfusion imaging to confirm myocardial ischaemia in the patient having coronary heart disease.

  • Patients complying with the diagnosis of UA and having at least one of the following conditions19: (1) ECG with a transient or persistent ST-segment depression of 0.1 mV and even more on one or more leads20; (2) thrombolysis in myocardial infarction risk score ≥3.21

  • Patients receiving dual antiplatelet therapy (aspirin+clopidogrel).

  • Patients aged 40–75 years, irrespective of sex.

  • Patients willing to accept the drug treatment and provide written informed consent, conforming to the relevant regulations of good clinical practice.

  • Patients with cardiac function class IV (New York Heart Association cardiac function grading); or patients at a high risk of unstable angina short-term risk stratification.

  • Patients with uncontrolled grade III hypertension having systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg; severe cardiopulmonary insufficiency; severe arrhythmia; severe primary diseases of the liver, kidney and haematopoietic system; or serious diseases (such as tumours) and mental diseases.

  • Patients also having other clinical conditions that might increase the risk of bleeding, such as a history of important organ bleeding in the last 6 months (such as intracerebral haemorrhage and upper gastrointestinal bleeding), decreased platelet count, abnormal coagulation function and recent active bleeding.

  • Patients with abnormal function indexes of the liver and kidney(blood alanine aminotransferase and aspartate aminotransferase level more than two times the upper normal reference range; glomerular filtration rate (GFR) <60 mL/(min ×1.73 m²)).

  • Simplified modification of diet in renal disease formula: GFR (mL/(min ×1.73 m²))= 186.3 × serum creatinine (Scr)–1.154 × (age) –0.203 × (0.742 female); Scr in mg/dL and age in years.

  • Patients who planned to undergo revascularisation (PCI or coronary artery bypass grafting) recently.

  • Patients allergic to a variety of foods, or with known allergy to study drugs, including their components.

  • Patients pregnant, preparing for pregnancy or lactating.

  • Patients participating in other clinical trials during the same period.

  • Patients considered inappropriate to participate in this study.

PCI, percutaneous coronary intervention.