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OpenTrials
Completed

NCT Number: NCT05906199

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.

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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Key information

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SKChemicals, Seongnam, Gyunggi-do, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<Inclusion Criteria>

  • 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

<Exclusion Criteria>

  • 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

Treatment and study plan

Renexin CR 200/160mg

Drug

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

Other names: Renexin CR

Aspirin 100mg

Drug

Single oral administration of Aspirin 100mg, QD

Other names: Aspirin

Primary outcomes

  1. Changes in carotid IMT

    Time frame: 24weeks, 48weeks

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

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV, Exploratory Clinical Trial to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract (Renexin CR) and Aspirin (Aspirin Protect Tab.) in Diabetic Peripheral Angiopathy.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.