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

Stable Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04308551
• Other study ID #: HenanICE202001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2021
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: junhui zhang, MD
• Phone: +86 0371-58681033
• Email: 09junhuizhang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 594
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Coronary Heart Disease

Intervention

Drug:
• Indobufen
Indobufen Tablets
• Aspirin
Aspirin Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin	Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 7 days.	7 days
Primary	Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin	Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 30 days.	30 days
Primary	Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin	Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 90 days.	90 days
Primary	Concentration of Thromboxane B2 (TXB2) at baseline	The fasting blood was collected after the subjects signed informed consent;And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)	baseline
Primary	Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin	The fasting blood was collected 7 days after taking the Indobufen or Aspirin;And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)	7 days
Primary	Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin	The fasting blood was collected 30 days after taking the Indobufen or Aspirin;And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)	30 days
Primary	Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin	The fasting blood was collected 90 days after taking the Indobufen or Aspirin;And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)	90 days
Secondary	Incidence of Bleeding	During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced bleeding (the extent and location of the bleeding) and the degree of bleeding related to indobufen or aspirin (Certainly, likely, possible, suspicious, impossible)	baseline, 7, 30 and 90 days
Secondary	Incidence of Adverse Gastrointestinal reaction	During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced adverse gastrointestinal reaction, such as nausea, vomiting, upper abdominal discomfort or pain, gastric mucosal damage, gastric ulcers and bleeding, etc	7, 30 and 90 days
Secondary	Blood concentration	The fasting blood was collected on the day of 7 days, 30 days, and 90 days;And the blood concentration of aspirin or indobufen or clopidogrel or ticagrelor was detected.	7, 30 and 90 days
Secondary	Cyclooxygenase-1 gene phenotype	The fasting blood was collected and saved on the day of enrollment, and then the gene phenotype of cyclooxygenase-1 would be detected, and their relationship with platelet aggregation also would be analyzed.	baseline
Secondary	Major adverse cardiovascular events	Number of angina pectoris symptoms, non ST-segment elevation myocardial infarction (NSTEMI), ST-segment elevation myocardial infarction (STEMI), stroke, cardiovascular death, cerebrovascular death, all-cause death	7, 30 and 90 days