Chronic Occlusive Arterial Disease
Conditions
Brief summary
The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.
Detailed description
The purpose of this study is to evaluate the effect of Anple-one SR Tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of Anpl-one SR Tablet (sarpogrelate hydrochloride agent) using PAQ.
Interventions
Anpl-one SR
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adults over 19 and under 80 years of age. 2. Patients who first administered Sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (Burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.). 3. Patient who voluntarily signed a written consent form approved by the Clinical Trial Review Committee or Ethics Committee and agreed to participate in the study by the patient or the subject's agent.
Exclusion criteria
1. Patient who is expected to have less than two years of life expectancy. 2. Patient who have bleeding within a week of participation in the study 3. Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.). 4. A female patient who is likely to be pregnant or pregnant. 5. Female patients who are lactating or are scheduled to be lactated at the time of participation in the study. 6. Patients with severe renal disease and liver disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peripheral Artery Questionnaire | 24 weeks | Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Artery Questionnaire change | 12 weeks | Peripheral Artery Questionnaire change at 12 weeks compared to baseline |
| Change in each domain of Peripheral Artery Questionnaire | 24 weeks | Change in each domain of Peripheral Artery Questionnaire at 24 weeks compared to baseline |
| Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients | 12 weeks | Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 12 weeks |
Countries
South Korea