Blood Viscosity, Coronary Artery Disease, Peripheral Arterial Disease, Sarpogrelate
Conditions
Keywords
Sarpogrelate Sustained Release
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
Interventions
DRUGSarpogrelate Sustained Release/Aspirin
Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
DRUGAspirin
Aspirin 100mg qd for 12 weeks
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer | Baseline/Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer | Baseline/Week 4 |
| 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 |
| Rate of change from baseline to week 4, 12 in Lipid profile | Baseline/Week 4/Week 12 |
Countries
South Korea
Outcome results
None listed