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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2024-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Sarpogrelate Blood Viscosity Peripheral Arterial Disease Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sarpogrelate Sustained Release/Aspirin

Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks

Group Type EXPERIMENTAL

Sarpogrelate Sustained Release/Aspirin

Intervention Type DRUG

Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks

Aspirin

Aspirin Monotherapy qd for 12 weeks

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

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

Intervention Type DRUG

Aspirin

Aspirin 100mg qd for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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South Korea

Other Identifiers

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YMC047

Identifier Type: -

Identifier Source: org_study_id

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