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

Coronary Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05105750
• Other study ID #: 016
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2021
• Est. completion date: March 20, 2022

Study information

• Verified date: October 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Li Chunjian, Ph.D
• Phone: 86-25-83718836
• Email: lijay[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 20, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of coronary atherosclerosis without indications for stent implantation.

2. Age = 18 years, = 65 years

3. Sign informed consent

Exclusion Criteria:

1. A history of asthma or allergic constitution or known allergy to indobufen or aspirin.

2. High risk of bleeding (low hemoglobin 10g / L, history of peptic ulcer disease, fecal occult blood positive or known active bleeding, history of cerebral hemorrhage within 6 months, history of fundus hemorrhage, etc).

3. Creatinine was 1.2 times higher than the upper limit of normal value and ALT was 1.2 times higher than the normal value.

4. History of smoking and alcoholism.

5. History of diabetes.

6. Pregnancy and lactation women.

7. Nonsteroidal anti-inflammatory or other antithrombotic drugs other than indobufen are required.

8. Any other reason may affect the results of this study.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Intervention

Drug:
• aspirin 100 mg/d
100mg aspirin for at least 3 days followed by aspirin 100 mg/d
• indobufen 200 mg bid
100mg aspirin for at least 3 days followed by indobufen 200 mg bid

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPA	Maximum platelet aggregation induced by arachidonic acid	Within 24 hours after one month of medication
Primary	TXB2	Plasma thromboxaneB2	Within 1 month after one month of medication
Primary	11-dh-TXB2	Urine 11-dehydro thromboxaneB2	Within 1 month after one month of medication
Secondary	Adverse Events	Monitor the bleeding events of subjects during the trial	Within 1 month after the first medication