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

YMC047

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

2023-01-11

2024-02-28

2024-02-28

Recruiting

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-02-16