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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Sarpogrelate, Blood Viscosity, Peripheral Arterial Disease, Coronary Artery Disease

Intervention / Treatment
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* Drug: Sarpogrelate Sustained Release/Aspirin
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sarpogrelate Sustained Release/Aspirin<br>Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks | Drug: Sarpogrelate Sustained Release/Aspirin<br>* Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks<br>|
| Active Comparator: Aspirin<br>Aspirin Monotherapy qd for 12 weeks | Drug: Aspirin<br>* Aspirin 100mg qd for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer |  | Baseline/Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more |  | Week 12 | 
| Rate of change from baseline to week 4, 12 in Lipid profile |  | Baseline/Week 4/Week 12 | 
| Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose) |  | Baseline/Week 4/Week 12 | 
| Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) |  | Baseline/Week 4/Week 12 | 
| Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein) |  | Baseline/Week 4/Week 12 | 
| Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item) |  | Baseline/Week 12 | 
| Change from baseline to week 12 in VAS(Visual Analogue Scale) |  | Baseline/Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarpogrelate Sustained Release