Back to resultsA Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
Primary Purpose
Coronary Atherosclerosis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
aspirin 100 mg/d
indobufen 200 mg bid
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Atherosclerosis focused on measuring Light Transmittance Aggregometry, Indobufen, Aspirin, Plasma Thromboxane, Urine 11-dehydro thromboxane
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of coronary atherosclerosis without indications for stent implantation.
- Age ≥ 18 years, ≤ 65 years
- Sign informed consent
Exclusion Criteria:
- A history of asthma or allergic constitution or known allergy to indobufen or aspirin.
- 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).
- Creatinine was 1.2 times higher than the upper limit of normal value and ALT was 1.2 times higher than the normal value.
- History of smoking and alcoholism.
- History of diabetes.
- Pregnancy and lactation women.
- Nonsteroidal anti-inflammatory or other antithrombotic drugs other than indobufen are required.
- Any other reason may affect the results of this study.
Sites / Locations
- First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
aspirin 100 mg/d therapy
indobufen 200 mg bid therapy
Arm Description
Outcomes
Primary Outcome Measures
MPA
Maximum platelet aggregation induced by arachidonic acid
TXB2
Plasma thromboxaneB2
11-dh-TXB2
Urine 11-dehydro thromboxaneB2
Secondary Outcome Measures
Adverse Events
Monitor the bleeding events of subjects during the trial
Full Information
NCT ID
NCT05105750
First Posted
October 12, 2021
Last Updated
January 18, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05105750
Brief Title
A Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
Official Title
A Comparative Study on Antiplatelet Efficacy of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
March 20, 2022 (Anticipated)
Study Completion Date
March 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis
Keywords
Light Transmittance Aggregometry, Indobufen, Aspirin, Plasma Thromboxane, Urine 11-dehydro thromboxane
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aspirin 100 mg/d therapy
Arm Type
Active Comparator
Arm Title
indobufen 200 mg bid therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
aspirin 100 mg/d
Intervention Description
100mg aspirin for at least 3 days followed by aspirin 100 mg/d
Intervention Type
Drug
Intervention Name(s)
indobufen 200 mg bid
Intervention Description
100mg aspirin for at least 3 days followed by indobufen 200 mg bid
Primary Outcome Measure Information:
Title
MPA
Description
Maximum platelet aggregation induced by arachidonic acid
Time Frame
Within 24 hours after one month of medication
Title
TXB2
Description
Plasma thromboxaneB2
Time Frame
Within 1 month after one month of medication
Title
11-dh-TXB2
Description
Urine 11-dehydro thromboxaneB2
Time Frame
Within 1 month after one month of medication
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Monitor the bleeding events of subjects during the trial
Time Frame
Within 1 month after the first medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of coronary atherosclerosis without indications for stent implantation.
Age ≥ 18 years, ≤ 65 years
Sign informed consent
Exclusion Criteria:
A history of asthma or allergic constitution or known allergy to indobufen or aspirin.
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).
Creatinine was 1.2 times higher than the upper limit of normal value and ALT was 1.2 times higher than the normal value.
History of smoking and alcoholism.
History of diabetes.
Pregnancy and lactation women.
Nonsteroidal anti-inflammatory or other antithrombotic drugs other than indobufen are required.
Any other reason may affect the results of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Chunjian, Ph.D
Phone
86-25-83718836
Email
lijay@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Zekang
Phone
17816872076
Email
yezekang@njmu.edu.cn
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuming Zhang, M.D.
Phone
+86-25-83718836
Ext
6360
Email
jsphkj@163.com
First Name & Middle Initial & Last Name & Degree
Yi Chai, M.D.
Phone
+86-25-83718836
Ext
6360
Email
jsphkj@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
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