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

Completed

• Conditions: Chronic Occlusive Arterial Disease
• Interventions: Drug: Sarpogrelate

• Registration Number: NCT05083299
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Study Timeline

• Study Start: 2020-01-28
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anpl-one SR Tablet	Sarpogrelate	Patients who prescribed Anpl-one SR Tablet

Primary Outcome Measures

Name	Time	Method
Change in Peripheral Artery Questionnaire	24 weeks	Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline

Secondary Outcome Measures

Name	Time	Method
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients	24 weeks	Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 24 weeks
Peripheral Artery Questionnaire change	24 weeks	Peripheral Artery Questionnaire change at 24 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

Trial Locations

Locations (1)

BuKyung Kim; 🇰🇷 Busan, Korea, Republic of