Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Institute of Cardiovascular Epidemiology
• Treatments: Aspirin; Indobufen

Criteria

Inclusion Criteria:

1. 18 years < age ≤ 85 years;

2. Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);

2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosis of the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the left anterior descending branch（LAD）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia;

2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or 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 ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.

3. Willing to sign the informed consent.

Exclusion Criteria:

1. Acute coronary syndrome (ACS) occurred within 3 months before screening;

2. Percutaneous coronary intervention or CABG surgery within 9 months before screening;

3. Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;

4. In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;

5. Congestive heart failure or left ventricular ejection fraction <35%;

6. A positive history of Chronic Obstructive Pulmonary Disease (COPD);

7. bleeding tendency or severe lung disease;

8. Active pathological bleeding;

9. History of intracranial hemorrhage (less than 3 months);

10. Allergic to indobufen / aspirin (or any of its ingredients);

11. Severe liver injury (transaminases exceeding the upper limit of 2 times and above);

12. Pregnancy, lactation and those who have a birth plan;

13. Hematological diseases, platelet count <100000 / mm3 or hemoglobin <10g / dL;

14. Have a history of drug or alcohol abuse in the past 2 years;

15. Use of non-steroidal anti-inflammatory drugs (within 3 months);

16. Creatinine clearance <30ml/min;