A Study to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract and Aspirin in Diabetic Peripheral Angiopathy.

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2023-12-13

Brief Summary

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This study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.

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Detailed Description

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A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV

Conditions

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Diabetic Peripheral Angiopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renexin CR 200/160mg

Single oral administration of Renexin CR 200/160mg, QD

Group Type EXPERIMENTAL

Renexin CR 200/160mg

Intervention Type DRUG

Single oral administration of Renexin CR 200/160mg, QD

Aspirin 100mg

Single oral administration of Aspirin 100mg, QD

Group Type ACTIVE_COMPARATOR

Aspirin 100mg

Intervention Type DRUG

Single oral administration of Aspirin 100mg, QD

Interventions

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Renexin CR 200/160mg

Single oral administration of Renexin CR 200/160mg, QD

Intervention Type DRUG

Aspirin 100mg

Single oral administration of Aspirin 100mg, QD

Intervention Type DRUG

Other Intervention Names

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Renexin CR Aspirin

Eligibility Criteria

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Inclusion Criteria

1. Male or female aged between 20 years and 75 years(inclusive)
2. Patients who diagnosed as type 2 diabetes and diabetic peripheral angiopathy
3. Patients with a maximum intra-carotid membrane thickness (maximum IMT) of 0.9 mm or more among the thickest areas, including plaques, in the CCA, ICA, and Bulb three areas of the carotid artery

Exclusion Criteria

1. Patients who diagnosed with type 1 diabetes, secondary diabetes, or gestational diabetes
2. Patients with cerebrovascular or cardiovascular complications within 6 months of screening (cerebral infarction, transient ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft(CABG), PCI, etc.)
3. Patients with bleeding (hemophilia, capillary weakness, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hematopoietic hemorrhage, active digestive ulcers, etc.) or peptic ulcers within 3 months of screening
4. Patient who took anticoagulants, antiplatelet drugs including aspirin, cilostazol, thrombolytic agents, prostaglandin E1 and glucagon-like peptide -1 (GLP-1) receptor agonist within 2 weeks of the baseline

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No