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In addition, studies have found that indobufen can inhibit coagulation function in rats. Compared with aspirin, the duration of antiplatelet efficacy of indobufen was shorter, and the platelet function recovered completely 24 hours after drug withdrawal. However, there are few studies on the antiplatelet efficacy of indobufen. The investigators' previous study found that the inhibitory effect of indobufen 100 mg Bid on COX system in atherosclerosis or healthy volunteers was equivalent to that of aspirin 100 mg QD, but the inhibitory effect on platelet COX-1 channel was significantly weaker than that of aspirin 100 mg QD. In view of this, this study intends to investigate the antiplatelet effect of indobufen 200 mg Bid in patients with coronary atherosclerosis by comparing it with conventional-dose aspirin 100 mg QD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspirin 100 mg/d therapy | Active Comparator |
| |
| indobufen 200 mg bid therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin 100 mg/d | Drug | 100mg aspirin for at least 3 days followed by aspirin 100 mg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| MPA | Maximum platelet aggregation induced by arachidonic acid | Within 24 hours after one month of medication |
| TXB2 | Plasma thromboxaneB2 | Within 1 month after one month of medication |
| 11-dh-TXB2 | Urine 11-dehydro thromboxaneB2 | Within 1 month after one month of medication |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Monitor the bleeding events of subjects during the trial | Within 1 month after the first medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Chunjian, Ph.D | Contact | 86-25-83718836 | lijay@njmu.edu.cn | |
| Ye Zekang | Contact | 17816872076 | yezekang@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C020371 | indobufen |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| indobufen 200 mg bid | Drug | 100mg aspirin for at least 3 days followed by indobufen 200 mg bid |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |