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NCT Number: NCT05730621

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

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

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Key information

Conditions

Sarpogrelate Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Blood Viscosity Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sarpogrelate Sustained Release/Aspirin

Drug

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

Aspirin

Drug

Aspirin 100mg qd for 12 weeks

Primary outcomes

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

    Time frame: Baseline/Week 12

Secondary outcomes

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

    Time frame: Baseline/Week 4

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

    Time frame: Baseline/Week 4/Week 12

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

    Time frame: Baseline/Week 4/Week 12

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

    Time frame: Baseline/Week 4/Week 12

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

    Time frame: Baseline/Week 4/Week 12

  6. Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more

    Time frame: Week 12

  7. Rate of change from baseline to week 4, 12 in Lipid profile

    Time frame: Baseline/Week 4/Week 12

  8. Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)

    Time frame: Baseline/Week 4/Week 12

  9. Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)

    Time frame: Baseline/Week 4/Week 12

  10. Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)

    Time frame: Baseline/Week 4/Week 12

  11. Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)

    Time frame: Baseline/Week 12

  12. Change from baseline to week 12 in VAS(Visual Analogue Scale)

    Time frame: Baseline/Week 12

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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; A Prospective, Randomized, Parallel, Open-Label, Single-center, Phase IV Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2023
Registry last updated
Jan 22, 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.

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