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
NCT ID: NCT05730621
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2023-01-11
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sarpogrelate Sustained Release/Aspirin
Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks
Sarpogrelate Sustained Release/Aspirin
Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
Aspirin
Aspirin Monotherapy qd for 12 weeks
Aspirin
Aspirin 100mg qd for 12 weeks
Interventions
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Sarpogrelate Sustained Release/Aspirin
Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
Aspirin
Aspirin 100mg qd for 12 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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KeunSang Yum
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Locations
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The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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YMC047
Identifier Type: -
Identifier Source: org_study_id
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