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

Sponsor

Yuhan Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05730621

Collaborator

(none)

Enrollment

Location

Arms

13.6

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sarpogrelate Blood Viscosity Peripheral Arterial Disease Coronary Artery Disease	Drug: Sarpogrelate Sustained Release/Aspirin Drug: Aspirin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sarpogrelate Sustained Release/Aspirin Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks	Drug: Sarpogrelate Sustained Release/Aspirin Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
Active Comparator: Aspirin Aspirin Monotherapy qd for 12 weeks	Drug: Aspirin Aspirin 100mg qd for 12 weeks

Arm

Intervention/Treatment

Experimental: Sarpogrelate Sustained Release/Aspirin

Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks

Drug: Sarpogrelate Sustained Release/Aspirin

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

Active Comparator: Aspirin

Aspirin Monotherapy qd for 12 weeks

Drug: Aspirin

Aspirin 100mg qd for 12 weeks

Outcome Measures

Primary Outcome Measures

Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer [Baseline/Week 12]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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