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

Last updated: January 21, 2025
Sponsor: Yuhan Corporation
Overall Status: Completed

Phase

4

Condition

Circulation Disorders

Claudication

Vascular Diseases

Treatment

Aspirin

Sarpogrelate Sustained Release/Aspirin

Clinical Study ID

NCT05730621
YMC047
  • Ages > 19
  • All Genders

Study 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

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(Coronarycomputed tomography angiography)

  3. Patients who diagnosed with peripheral artery disease or has symptoms

  4. Written informed consent

Exclusion

Exclusion Criteria:

  1. Patients who is scheduled surgery due to coronary artery disease or cerebralinfarction 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)

  1. Patients with a history of cerebrovascular and cardiovascular complications (braininfarction, transient cerebral ischemic seizures, myocardial infarction, unstableangina, coronary artery bypass graft, percutaneous coronary artery intervention)within the last six months

  2. Patients with bleeding

  3. Pregnant or lactating women

  4. Those participating in other clinical trials for investigational products

  5. Patients deemed to be ineligible to participate in the trial by investigator

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Aspirin
Phase: 4
Study Start date:
January 11, 2023
Estimated Completion Date:
February 28, 2024

Connect with a study center

  • The Catholic University of Korea Uijeongbu St. Mary's Hospital

    Uijeongbu, Gyeonggi-do 11765
    Korea, Republic of

    Site Not Available

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