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

Last updated: November 17, 2024
Sponsor: Henan Institute of Cardiovascular Epidemiology
Overall Status: Trial Not Available

Phase

N/A

Condition

Coronary Artery Disease

Vascular Diseases

Hypercholesterolemia

Treatment

Indobufen

Aspirin

Clinical Study ID

NCT04308551
HenanICE202001
  • Ages 18-85
  • All Genders

Study 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

Inclusion Criteria:

  1. 18 years < age ≤ 85 years;

  2. 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.

  1. Willing to sign the informed consent.

Exclusion

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, lowerextremity venous thrombosis, artificial heart valve, etc.) who need oral orintravenous 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;

Study Design

Treatment Group(s): 2
Primary Treatment: Indobufen
Phase:
Study Start date:
December 30, 2024
Estimated Completion Date:
December 30, 2026