NCT05105750

A Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis

A Comparative Study on Antiplatelet Efficacy of Indobufen and Aspirin in Patients With Coronary Atherosclerosis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Atherosclerosis

Interventions

Type	Name	Description
DRUG	aspirin 100 mg/d	100mg aspirin for at least 3 days followed by aspirin 100 mg/d
DRUG	indobufen 200 mg bid	100mg aspirin for at least 3 days followed by indobufen 200 mg bid

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-03-20
• Completion: 2022-03-20
• First posted: 2021-11-03
• Last updated: 2022-01-19

Locations

1 site across 1 country: China