Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate

NCT05083299 | Completed

• 1 other identifier: DWAP_P401
• Study Type: observational
• Target: 1,003
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the effect of Anpl-one SR Tablet on the improvement of symptoms in daily care environments using PAQ.

Conditions

Chronic Occlusive Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change in Peripheral Artery Questionnaire

  Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline

  24 weeks

Secondary Outcomes (5)

• Peripheral Artery Questionnaire change

  12 weeks

• Peripheral Artery Questionnaire change

  24 weeks

• Change in each domain of Peripheral Artery Questionnaire

  24 weeks

• 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

  24 weeks

Study Arms (1)

Anpl-one SR Tablet

Patients who prescribed Anpl-one SR Tablet

Drug: Sarpogrelate

Interventions

Sarpogrelate DRUG

Anpl-one SR

Also known as: Anpl-one SR

Anpl-one SR Tablet

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%.

You may qualify if:

• Adults over 19 and under 80 years of age.
• 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.).
• 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.

You may not qualify if:

• Patient who is expected to have less than two years of life expectancy.
• Patient who have bleeding within a week of participation in the study
• Patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.).
• A female patient who is likely to be pregnant or pregnant.
• Female patients who are lactating or are scheduled to be lactated at the time of participation in the study.
• Patients with severe renal disease and liver disease.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

BuKyung Kim

Busan, 49267, South Korea

Location

MeSH Terms

Interventions

sarpogrelate

Study Officials

• BuKyung Kim

  Kosin University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: January 28, 2020
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)