Clinical trial NCT05083299: Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate
Official title: Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Occlusive Arterial Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 1003
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As a result of the calculation for the number of survey subjects in this study, a total of 1507 subjects are required, and a total of 1,884 subjects are planned to be recruited in consideration of the dropout rate of 20%.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Peripheral Artery Questionnaire
timeFrame: 24 weeks
Secondary outcomes:
measure: Peripheral Artery Questionnaire change
timeFrame: 12 weeks
measure: Peripheral Artery Questionnaire change
timeFrame: 24 weeks
measure: Change in each domain of Peripheral Artery Questionnaire
timeFrame: 24 weeks
measure: Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients
timeFrame: 12 weeks
measure: Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: BuKyung Kim
Study officials:
affiliation: Kosin University Hospital
name: BuKyung Kim
role: PRINCIPAL_INVESTIGATOR
References: