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

NCT ID: NCT05105750

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

aspirin 100 mg/d therapy

Group Type ACTIVE_COMPARATOR

aspirin 100 mg/d

Intervention Type DRUG

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

indobufen 200 mg bid therapy

Group Type EXPERIMENTAL

indobufen 200 mg bid

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aspirin 100 mg/d

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

Intervention Type DRUG

indobufen 200 mg bid

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chunjian Li

Dr., MD, Ph.D, Director of CCU Ward

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Li Chunjian, Ph.D

Role: CONTACT

86-25-83718836

Ye Zekang

Role: CONTACT

17816872076

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fuming Zhang, M.D.

Role: primary

+86-25-83718836 ext. 6360

Yi Chai, M.D.

Role: backup

+86-25-83718836 ext. 6360

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Recurrent Carotid Stenosis
NCT00000527 COMPLETED PHASE2