A Study to Compare the Effects of Sarpogrelate Sustained Release /Aspirin Combination Therapy Versus Aspirin on Blood Viscosity in the Patients With Peripheral Arterial Disease and Coronary Artery Disease

NCT05730621 | Completed Phase 4

• 1 other identifier: YMC047
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to compare the effects of sarpogrelate sustained release /aspirin combination therapy versus aspirin on blood viscosity in the patients with peripheral arterial disease and coronary artery disease

Conditions

Sarpogrelate; Blood Viscosity; Peripheral Arterial Disease; Coronary Artery Disease

Keywords

Sarpogrelate Sustained Release

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer

  Baseline/Week 12

Secondary Outcomes (12)

• Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer

  Baseline/Week 4

• Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method

  Baseline/Week 4/Week 12

• Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method

  Baseline/Week 4/Week 12

• Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement

  Baseline/Week 4/Week 12

• Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)

  Baseline/Week 4/Week 12

Study Arms (2)

Sarpogrelate Sustained Release/Aspirin

EXPERIMENTAL

Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks

Drug: Sarpogrelate Sustained Release/Aspirin

Aspirin

ACTIVE COMPARATOR

Aspirin Monotherapy qd for 12 weeks

Drug: Aspirin

Interventions

Sarpogrelate Sustained Release/Aspirin DRUG

Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks

Sarpogrelate Sustained Release/Aspirin

Aspirin DRUG

Aspirin 100mg qd for 12 weeks

Aspirin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both man and woman who is over 19 years old
• Identified as 10-75% of Stenosis in Coronary Angiography or Coronary CTA(Coronary computed tomography angiography)
• Patients who diagnosed with peripheral artery disease or has symptoms
• Written informed consent

You may not qualify if:

• Patients who is scheduled surgery due to coronary artery disease or cerebral infarction disease.
• Patients who have taken aspirin within two weeks before randomization
• Patients who need antiplatelet or anticoagulant medication except Aspirin
• Confirmed below results at screening
• Hemoglobin \<13g/dL
• Platelet \<60,000/µL
• Severe kidney disease patient with eGFR(estimated Glomerular Filtration Rate) \<30 mL/min/1.73 m2 (CKD-EPI)
• Patients with a history of cerebrovascular and cardiovascular complications (brain infarction, transient cerebral ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary artery intervention) within the last six months
• Patients with bleeding
• Pregnant or lactating women
• Those participating in other clinical trials for investigational products
• Patients deemed to be ineligible to participate in the trial by investigator

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, 11765, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• KeunSang Yum

  The Catholic University of Korea Uijeongbu St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

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: January 26, 2023
• First Posted: February 16, 2023
• Study Start: January 11, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)