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

January 21, 2025 updated by: Yuhan Corporation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Uijeongbu, Gyeonggi-do, Korea, Republic of, 11765
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sarpogrelate Sustained Release/Aspirin
Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks
Drug: Sarpogrelate Sustained Release/Aspirin
Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
Active Comparator: Aspirin
Aspirin Monotherapy qd for 12 weeks
Drug: Aspirin
Aspirin 100mg qd for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Time Frame: Baseline/Week 12
Baseline/Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer
Time Frame: Baseline/Week 4
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
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
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
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
Baseline/Week 4/Week 12
Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more
Time Frame: Week 12
Week 12
Rate of change from baseline to week 4, 12 in Lipid profile
Time Frame: Baseline/Week 4/Week 12
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
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
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
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
Baseline/Week 12
Change from baseline to week 12 in VAS(Visual Analogue Scale)
Time Frame: Baseline/Week 12
Baseline/Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuhan Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: KeunSang Yum, The Catholic University of Korea Uijeongbu St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YMC047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings