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

Henan Institute of Cardiovascular Epidemiology

Status: Withdrawn

Conditions: Stable Coronary Heart Disease

Treatments: Drug: Aspirin; Drug: Indobufen

Study type: Interventional

Funder types: Other

Identifiers

NCT04308551

HenanICE202001

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Indobufen

Experimental group

Description:

200 mg Indobufen, bid po, 90 days

Treatment:

Drug: Indobufen

Aspirin

Active Comparator group

Description:

100 mg Aspirin, qd po, 90 days

Treatment:

Drug: Aspirin