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.

SK chemicals

Status and phase: Completed; Phase 4

Conditions: Diabetic Peripheral Angiopathy

Treatments: Drug: Aspirin 100mg; Drug: Renexin CR 200/160mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05906199

RNX_001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 105 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

<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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Renexin CR 200/160mg

Experimental group

Description:

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

Treatment:

Drug: Renexin CR 200/160mg

Aspirin 100mg

Active Comparator group

Description:

Single oral administration of Aspirin 100mg, QD

Treatment:

Drug: Aspirin 100mg