NCT05105750

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

January 19, 2022

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

October 12, 2021

Last Update Submit

January 18, 2022

Conditions

Coronary Atherosclerosis

Keywords

Light Transmittance AggregometryIndobufenAspirinPlasma ThromboxaneUrine 11-dehydro thromboxane

Outcome Measures

Primary Outcomes (3)

  • MPA

    Maximum platelet aggregation induced by arachidonic acid

    Within 24 hours after one month of medication

  • TXB2

    Plasma thromboxaneB2

    Within 1 month after one month of medication

  • 11-dh-TXB2

    Urine 11-dehydro thromboxaneB2

    Within 1 month after one month of medication

Secondary Outcomes (1)

  • Adverse Events

    Within 1 month after the first medication

Study Arms (2)

aspirin 100 mg/d therapy

ACTIVE COMPARATOR
Drug: aspirin 100 mg/d

indobufen 200 mg bid therapy

EXPERIMENTAL
Drug: indobufen 200 mg bid

Interventions

aspirin 100 mg/dDRUG

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

aspirin 100 mg/d therapy
indobufen 200 mg bidDRUG

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

indobufen 200 mg bid therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of coronary atherosclerosis without indications for stent implantation.
  • Age ≥ 18 years, ≤ 65 years
  • Sign informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

AspirinindobufenBID protein, human

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Li Chunjian, Ph.D

CONTACT

86-25-83718836lijay@njmu.edu.cn

Ye Zekang

CONTACT

17816872076yezekang@njmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., MD, Ph.D, Director of CCU Ward

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 3, 2021

Study Start

October 15, 2021

Primary Completion

March 20, 2022

Study Completion

March 20, 2022

Last Updated

January 19, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)