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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05105750
Collaborator
(none)
60
1
2
5.1
11.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: aspirin 100 mg/d
  • Drug: indobufen 200 mg bid
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparative Study on Antiplatelet Efficacy of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
Actual Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Mar 20, 2022
Anticipated Study Completion Date :
Mar 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: aspirin 100 mg/d therapy

Drug: aspirin 100 mg/d
100mg aspirin for at least 3 days followed by aspirin 100 mg/d

Experimental: indobufen 200 mg bid therapy

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

Outcome Measures

Primary Outcome Measures

  1. MPA [Within 24 hours after one month of medication]

    Maximum platelet aggregation induced by arachidonic acid

  2. TXB2 [Within 1 month after one month of medication]

    Plasma thromboxaneB2

  3. 11-dh-TXB2 [Within 1 month after one month of medication]

    Urine 11-dehydro thromboxaneB2

Secondary Outcome Measures

  1. Adverse Events [Within 1 month after the first medication]

    Monitor the bleeding events of subjects during the trial

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210029

Sponsors and Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunjian Li, Dr., MD, Ph.D, Director of CCU Ward, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05105750
Other Study ID Numbers:
  • 016
First Posted:
Nov 3, 2021
Last Update Posted:
Jan 19, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chunjian Li, Dr., MD, Ph.D, Director of CCU Ward, The First Affiliated Hospital with Nanjing Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022