Back to resultsA 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
Primary Purpose
Sarpogrelate, Blood Viscosity, Peripheral Arterial Disease
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sarpogrelate Sustained Release/Aspirin
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Sarpogrelate focused on measuring Sarpogrelate Sustained Release
Eligibility Criteria
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
Sites / Locations
- The Catholic University of Korea Uijeongbu St. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sarpogrelate Sustained Release/Aspirin
Aspirin
Arm Description
Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks
Aspirin Monotherapy qd for 12 weeks
Outcomes
Primary Outcome Measures
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Secondary Outcome Measures
Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method
Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method
Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement
Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)
Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more
Rate of change from baseline to week 4, 12 in Lipid profile
Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)
Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)
Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)
Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)
Change from baseline to week 12 in VAS(Visual Analogue Scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05730621
Brief 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
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarpogrelate, Blood Viscosity, Peripheral Arterial Disease, Coronary Artery Disease
Keywords
Sarpogrelate Sustained Release
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sarpogrelate Sustained Release/Aspirin
Arm Type
Experimental
Arm Description
Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Aspirin Monotherapy qd for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Sarpogrelate Sustained Release/Aspirin
Intervention Description
Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 100mg qd for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Time Frame
Baseline/Week 12
Secondary Outcome Measure Information:
Title
Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Time Frame
Baseline/Week 4
Title
Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method
Time Frame
Baseline/Week 4/Week 12
Title
Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method
Time Frame
Baseline/Week 4/Week 12
Title
Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement
Time Frame
Baseline/Week 4/Week 12
Title
Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)
Time Frame
Baseline/Week 4/Week 12
Title
Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more
Time Frame
Week 12
Title
Rate of change from baseline to week 4, 12 in Lipid profile
Time Frame
Baseline/Week 4/Week 12
Title
Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)
Time Frame
Baseline/Week 4/Week 12
Title
Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)
Time Frame
Baseline/Week 4/Week 12
Title
Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)
Time Frame
Baseline/Week 4/Week 12
Title
Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)
Time Frame
Baseline/Week 12
Title
Change from baseline to week 12 in VAS(Visual Analogue Scale)
Time Frame
Baseline/Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JungWook Ahn
Phone
+82-2-828-0734
Email
ajw8299@yuhan.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KeunSang Yum
Organizational Affiliation
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea Uijeongbu St. Mary's Hospital
City
Uijeongbu
State/Province
Gyeonggi-do
ZIP/Postal Code
11765
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KeunSang Yum
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs