Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sarpogrelate
Blood Viscosity
Peripheral Arterial Disease
Coronary Artery Disease
Keywords: Sarpogrelate Sustained Release
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
timeFrame: Baseline/Week 12
Secondary outcomes:
measure: Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
timeFrame: Baseline/Week 4
measure: Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method
timeFrame: Baseline/Week 4/Week 12
measure: Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method
timeFrame: Baseline/Week 4/Week 12
measure: Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement
timeFrame: Baseline/Week 4/Week 12
measure: Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)
timeFrame: Baseline/Week 4/Week 12
measure: Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more
timeFrame: Week 12
measure: Rate of change from baseline to week 4, 12 in Lipid profile
timeFrame: Baseline/Week 4/Week 12
measure: Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)
timeFrame: Baseline/Week 4/Week 12
measure: Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)
timeFrame: Baseline/Week 4/Week 12
measure: Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)
timeFrame: Baseline/Week 4/Week 12
measure: Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)
timeFrame: Baseline/Week 12
measure: Change from baseline to week 12 in VAS(Visual Analogue Scale)
timeFrame: Baseline/Week 12
Other outcomes:
Locations:
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
state: Gyeonggi-do
Study officials:
affiliation: The Catholic University of Korea Uijeongbu St. Mary's Hospital
name: KeunSang Yum
role: PRINCIPAL_INVESTIGATOR
References: