SarpogrelatePhase 4NCT05730621
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 Phase 4 study testing Sarpogrelate Sustained Release/Aspirin and Aspirin in people with Sarpogrelate and Blood Viscosity, run by Yuhan Corporation at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sarpogrelate, Blood Viscosity, Peripheral Arterial Disease
- What is being tested?
- Sarpogrelate Sustained Release/Aspirin and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jan 2023to 28 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 11765
About this study
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
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
- Being tested
- Sarpogrelate Sustained Release/Aspirin, Aspirin
- Keywords
- Sarpogrelate Sustained Release
- Medical subject headings
- Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarpogrelate Sustained Release/AspirinDrug
Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
AspirinDrug
Aspirin 100mg qd for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sarpogrelate Sustained Release/Aspirin | Experimental | Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks Receives: Drug: Sarpogrelate Sustained Release/Aspirin |
| Aspirin | Active comparator | Aspirin Monotherapy qd for 12 weeks Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Measured: Baseline/Week 12
Secondary outcomes (12)
Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Measured: Baseline/Week 4
Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method
Measured: Baseline/Week 4/Week 12
Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method
Measured: Baseline/Week 4/Week 12
Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement
Measured: Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)
Measured: Baseline/Week 4/Week 12
Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more
Measured: Week 12
Rate of change from baseline to week 4, 12 in Lipid profile
Measured: Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)
Measured: Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)
Measured: Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)
Measured: Baseline/Week 4/Week 12
Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)
Measured: Baseline/Week 12
Change from baseline to week 12 in VAS(Visual Analogue Scale)
Measured: Baseline/Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start11 Jan 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarpogrelateStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KeunSang Yum, Principal investigator, The Catholic University of Korea, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730621
- Sponsor's protocol ID
- YMC047
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05730621
- Acronym / sponsor ID
- YMC047
- Keywords
- Sarpogrelate Sustained Release
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarpogrelate Sustained Release/Aspirin | Experimental | Drug: Sarpogrelate Sustained Release/AspirinSarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks |
| Aspirin | Active comparator | Drug: AspirinAspirin Monotherapy qd for 12 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarpogrelate Sustained Release/AspirinAspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks | Drug | Sarpogrelate Sustained Release/Aspirin |
| AspirinAspirin 100mg qd for 12 weeks | Drug | Aspirin |
Primary outcome
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Time frame: Baseline/Week 12
12 secondary outcomes
Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Time frame: Baseline/Week 4
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
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
Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement
Time frame: Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)
Time frame: Baseline/Week 4/Week 12
Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more
Time frame: Week 12
Rate of change from baseline to week 4, 12 in Lipid profile
Time frame: Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)
Time frame: Baseline/Week 4/Week 12
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
Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)
Time frame: Baseline/Week 4/Week 12
Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)
Time frame: Baseline/Week 12
Change from baseline to week 12 in VAS(Visual Analogue Scale)
Time frame: Baseline/Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Sarpogrelate
Not yet recruiting
Comparison of the Improvement and Safety of the Ankle Brachial Arterial Pressure Index of Sarpogrelate and Clopidogrel in Stroke Patients With Decreased Ankle Brachial Arterial Pressure Index and Intermittent Claudication of Lower Limb Vascular Atherosclerosis.
Stroke, Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KeunSang Yum principal investigator
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sarpogrelate Sustained Release/Aspirin and Aspirin in people with Sarpogrelate and Blood Viscosity, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer (time frame: Baseline/Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.