Status:
WITHDRAWN
Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease
Lead Sponsor:
Henan Institute of Cardiovascular Epidemiology
Conditions:
Stable Coronary Heart Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.
Eligibility Criteria
Inclusion
- 18 years \< age ≤ 85 years;
- Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);
- 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 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.
- 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.
- Willing to sign the informed consent.
Exclusion
- 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, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous 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;
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04308551
Start Date
December 30 2024
End Date
December 30 2026
Last Update
November 20 2024
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