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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730621
• Other study ID #: YMC047
• Status: Recruiting
• Phase: Phase 4
• Start date: January 11, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: Yuhan Corporation
• Contact: JungWook Ahn
• Phone: +82-2-828-0734
• Email: ajw8299[@]yuhan.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Viscosity
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Sarpogrelate Sustained Release/Aspirin
Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
• Aspirin
Aspirin 100mg qd for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Uijeongbu St. Mary's Hospital	Uijeongbu	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer		Baseline/Week 12
Secondary	Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer		Baseline/Week 4
Secondary	Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method		Baseline/Week 4/Week 12
Secondary	Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method		Baseline/Week 4/Week 12
Secondary	Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement		Baseline/Week 4/Week 12
Secondary	Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)		Baseline/Week 4/Week 12
Secondary	Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more		Week 12
Secondary	Rate of change from baseline to week 4, 12 in Lipid profile		Baseline/Week 4/Week 12
Secondary	Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)		Baseline/Week 4/Week 12
Secondary	Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)		Baseline/Week 4/Week 12
Secondary	Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)		Baseline/Week 4/Week 12
Secondary	Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)		Baseline/Week 12
Secondary	Change from baseline to week 12 in VAS(Visual Analogue Scale)		Baseline/Week 12