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

Phase 4

Completed

• Conditions: Sarpogrelate; Blood Viscosity; Coronary Artery Disease; Peripheral Arterial Disease
• Interventions: Drug: Sarpogrelate Sustained Release/Aspirin; Drug: Aspirin

• Registration Number: NCT05730621
• Lead Sponsor: Yuhan Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-16
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

Exclusion Criteria

1. Patients who is scheduled surgery due to coronary artery disease or cerebral infarction disease.

2. Patients who have taken aspirin within two weeks before randomization

3. Patients who need antiplatelet or anticoagulant medication except Aspirin

4. 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)

5. 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

6. Patients with bleeding

7. Pregnant or lactating women

8. Those participating in other clinical trials for investigational products

9. Patients deemed to be ineligible to participate in the trial by investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarpogrelate Sustained Release/Aspirin	Sarpogrelate Sustained Release/Aspirin	Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks
Aspirin	Aspirin	Aspirin Monotherapy qd for 12 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 12 in VAS(Visual Analogue Scale)	Baseline/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 hs-CRP(high sensitivity C-Reactive Protein)	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
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 HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)	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
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 FPG(Fasting Plasma Glucose)	Baseline/Week 4/Week 12

Trial Locations

Locations (1)

The Catholic University of Korea Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu, Gyeonggi-do, Korea, Republic of