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

Multicenter, Therapeutic Use Observational Study to Evaluate the Effects of Concurrent Therapy of Sarpogrelate on Symptom Improvement in Patients With Peripheral Arterial Disease

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

Study Overview

• Status: Completed
• Conditions: Chronic Occlusive Arterial Disease
• Intervention / Treatment: Drug: Sarpogrelate

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 Type: Observational
• Enrollment (Actual): 1003

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • BuKyung Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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%.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anpl-one SR Tablet; Patients who prescribed Anpl-one SR Tablet	Drug: Sarpogrelate; Anpl-one SR; Other Names: Anpl-one SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peripheral Artery Questionnaire	Change in Peripheral Artery Questionnaire at 24 weeks compared to baseline	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Artery Questionnaire change	Peripheral Artery Questionnaire change at 12 weeks compared to baseline	12 weeks
Peripheral Artery Questionnaire change	Peripheral Artery Questionnaire change at 24 weeks compared to baseline	24 weeks
Change in each domain of Peripheral Artery Questionnaire	Change in each domain of Peripheral Artery Questionnaire at 24 weeks compared to baseline	24 weeks
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients	Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 12 weeks	12 weeks
Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients	Confirm the relationship between the ABI criteria and PAQ related to the diagnosis of PAD patients at 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: BuKyung Kim, Kosin University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Serotonin Agents; Serotonin Antagonists; Sarpogrelate
• Other Study ID Numbers: DWAP_P401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No