Clinical trial NCT04308551: Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease
Official title: Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Stable Coronary Heart Disease. A Prospective, Randomized and Controlled，Single Blind, Single-center, Opening Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stable Coronary Heart Disease
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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;

Primary outcomes:
measure: Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin
timeFrame: 7 days
measure: Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin
timeFrame: 30 days
measure: Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin
timeFrame: 90 days
measure: Concentration of Thromboxane B2 (TXB2) at baseline
timeFrame: baseline
measure: Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin
timeFrame: 7 days
measure: Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin
timeFrame: 30 days
measure: Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of Bleeding
timeFrame: baseline, 7, 30 and 90 days
measure: Incidence of Adverse Gastrointestinal reaction
timeFrame: 7, 30 and 90 days
measure: Blood concentration
timeFrame: 7, 30 and 90 days
measure: Cyclooxygenase-1 gene phenotype
timeFrame: baseline
measure: Major adverse cardiovascular events
timeFrame: 7, 30 and 90 days
Other outcomes:
Locations:
Study officials:
affiliation: central china fuwai hospital
name: chuanyu gao, MD
role: PRINCIPAL_INVESTIGATOR
References: