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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05105750
Other study ID # 016
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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