NCT06046196

Brief Summary

This clinical trial aims to assess the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease, based on changes in the Ankle-Brachial Index (ABI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2020

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

September 13, 2023

Last Update Submit

September 13, 2023

Conditions

Arterial Occlusive DiseasesIntermittent Claudication

Keywords

Sarpogrelate Sustained ReleaseSarpogrelate

Outcome Measures

Primary Outcomes (1)

  • Change in Ankle-Brachial Index (ABI)

    To evaluate the efficacy following administration of Sarpogrelate SR

    from baseline to the 12-week and 24-week

Secondary Outcomes (4)

  • Change in Lower Limb Pain Visual Analogue Scale (VAS)

    from baseline to the 12-week and 24-week timepoints

  • Change in Medication Adherence Index (MMAS-8)

    from baseline to the 12-week and 24-week timepoints.

  • Change in Walking Impairment Questionnaire (WIQ)

    from baseline to the 12-week and 24-week timepoints

  • the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness

    at baseline, 12-week, and 24-week timepoints

Study Arms (2)

Sarpogrelate SR 300mg, QD

EXPERIMENTAL

Sarpogrelate SR 300mg, QD

Drug: Sarpogrelate SR

Sarpogrelate 100mg, TID

ACTIVE COMPARATOR

Sarpogrelate 100mg, TID

Drug: Sarpogrelate

Interventions

Sarpogrelate SRDRUG

Sarpogrelate SR 300mg, once a daily, for 24weeks

Also known as: Anplag SR Tab. 300mg
Sarpogrelate SR 300mg, QD
SarpogrelateDRUG

Sarpogrelate 100mg, 3 times a day, for 24weeks

Also known as: Anplag Tab. 100mg
Sarpogrelate 100mg, TID

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults aged ≥ 19
  • Diagnosis of chronic arterial occlusive disease
  • Experience of intermittent claudication symptoms for at least 3 months
  • Receiving Sarpogrelate for a minimum of 4 weeks prior to the baseline
  • Lower limb pain measured at VAS 40mm or higher at baseline

You may not qualify if:

  • Patients with coronary artery disease or cerebrovascular disease related to arteriosclerosis undergoing or scheduled for surgery or medication treatment
  • Patients with a history of severe heart failure within the 6 months prior to the screening
  • Patients with a history of bleeding
  • Patients receiving anticoagulants or medications with antiplatelet activity at baseline
  • Patients diagnosed with peripheral neuropathy and currently taking neuropathic pain medications
  • Patients with infectious or progressive fibrotic diseases such as rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GangNeung Asan Hospital

Gangneung-si, Gangwon-do, 25440, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Korea University ANAM Hospital

Seoul, 02841, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

Ulsan University Hospital

Ulsan, 44602, South Korea

Location

MeSH Terms

Conditions

Arterial Occlusive DiseasesIntermittent Claudication

Interventions

sarpogrelate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseasePeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jungyo Gwon

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

November 18, 2020

Primary Completion

March 9, 2023

Study Completion

March 9, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(7)