Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
shortage of funds
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indobufen | Experimental | 200 mg Indobufen, bid po, 90 days |
|
| Aspirin | Active Comparator | 100 mg Aspirin, qd po, 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indobufen | Drug | Indobufen Tablets |
| |
| Aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
18 years < age ≤ 85 years;
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.
Willing to sign the informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| chuanyu gao, MD | central china fuwai hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C020371 | indobufen |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
The treatment in this study was open. Optical density turbidimetric platelet aggregation (LTA) and thromboelastography (TEG) were used to detect the platelet aggregation rate induced by AA and ADP, and the metabolites were measured by ELISA. All were done by the laboratory personnel, and they were unaware of the setting of treatment medication (blind method).
| Drug |
Aspirin Tablets |
|
| 7 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |