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.

NCT05906199 | Completed Phase 4

• 1 other identifier: RNX_001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetic Peripheral Angiopathy

Outcome Measures

Primary Outcomes (1)

• Changes in carotid IMT

  Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product

  24weeks, 48weeks

Study Arms (2)

Renexin CR 200/160mg

EXPERIMENTAL

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

Drug: Renexin CR 200/160mg

Aspirin 100mg

ACTIVE COMPARATOR

Single oral administration of Aspirin 100mg, QD

Drug: Aspirin 100mg

Interventions

Renexin CR 200/160mg DRUG

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

Also known as: Renexin CR

Renexin CR 200/160mg

Aspirin 100mg DRUG

Single oral administration of Aspirin 100mg, QD

Also known as: Aspirin

Aspirin 100mg

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 20 years and 75 years(inclusive)
• Patients who diagnosed as type 2 diabetes and diabetic peripheral angiopathy
• 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

You may not qualify if:

• Patients who diagnosed with type 1 diabetes, secondary diabetes, or gestational diabetes
• 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.)
• 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
• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (2)

SKChemicals

Seongnam, Gyunggi-do, South Korea

Location

SK chemicals

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Hwang YC, Kim MK, Park JH, Yun HM, Kim SY, Lim S. Comparison of Efficacy and Safety of Cilostazol/Extract of Ginkgo biloba vs. Aspirin in Carotid Atherosclerosis in Patients with Diabetes Mellitus. Diabetes Metab J. 2025 Aug 13. doi: 10.4093/dmj.2025.0146. Online ahead of print.

  PMID: 40803668 DERIVED

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: July 28, 2021
• Primary Completion: June 23, 2023
• Study Completion: December 13, 2023
• Last Updated: March 12, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)