Phase
Condition
Coronary Artery Disease
Vascular Diseases
Hypercholesterolemia
Treatment
Indobufen
Aspirin
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years < age ≤ 85 years;
Patients with confirmed stable coronary heart disease (must meet at least one of thefollowing conditions);
2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosisof the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the leftanterior descending branch(LAD)is less than 70%, and the stenosis of the two orthree coronary arteries diameter is less than 70%, patient has no correspondingevidence of ischemia;
2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelettherapy (DAPT) time is greater than 9 months, without cardiovascular events andischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/dor ticagrelor 90mg (bid) dual antiplatelet therapy.
2.3 Patients after coronary artery bypass graft (CABG): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemicsymptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d orticagrelor 90mg (bid) dual antiplatelet therapy.
- Willing to sign the informed consent.
Exclusion
Exclusion Criteria:
Acute coronary syndrome (ACS) occurred within 3 months before screening;
Percutaneous coronary intervention or CABG surgery within 9 months before screening;
Any other conditions (such as atrial fibrillation, pulmonary embolism, lowerextremity venous thrombosis, artificial heart valve, etc.) who need oral orintravenous anticoagulation treatment;
In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%;inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
Congestive heart failure or left ventricular ejection fraction <35%;
A positive history of Chronic Obstructive Pulmonary Disease (COPD);
bleeding tendency or severe lung disease;
Active pathological bleeding;
History of intracranial hemorrhage (less than 3 months);
Allergic to indobufen / aspirin (or any of its ingredients);
Severe liver injury (transaminases exceeding the upper limit of 2 times and above);
Pregnancy, lactation and those who have a birth plan;
Hematological diseases, platelet count <100000 / mm3 or hemoglobin <10g / dL;
Have a history of drug or alcohol abuse in the past 2 years;
Use of non-steroidal anti-inflammatory drugs (within 3 months);
Creatinine clearance <30ml/min;