Clinical trial NCT06046196: Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease
Official title: A Randomized, Multicenter, Open-label, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients Having Intermittent Claudication Among Chronic Artery Occlusive Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Occlusive Diseases
Intermittent Claudication
Keywords: Sarpogrelate Sustained Release
Sarpogrelate
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 148
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: The clinical trial is a randomized, multicenter, open-label, parallel-group, Phase 4 study conducted to evaluate 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. Eligible patients who sign the informed consent form voluntarily will receive the investigational products. Subsequently, they will undergo observation and various assessments at the 12-week and 24-week visits. The trial is designed to determine whether Sarpogrelate SR 300mg once daily is inferior to Sarpogrelate 100mg three times daily in terms of changes in the Ankle-Brachial Index (ABI).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Ankle-Brachial Index (ABI)
timeFrame: from baseline to the 12-week and 24-week
Secondary outcomes:
measure: Change in Lower Limb Pain Visual Analogue Scale (VAS)
timeFrame: from baseline to the 12-week and 24-week timepoints
measure: Change in Medication Adherence Index (MMAS-8)
timeFrame: from baseline to the 12-week and 24-week timepoints.
measure: Change in Walking Impairment Questionnaire (WIQ)
timeFrame: from baseline to the 12-week and 24-week timepoints
measure: the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness
timeFrame: at baseline, 12-week, and 24-week timepoints
Other outcomes:
Locations:
city: Gangneung-si
country: Korea, Republic of
facility: GangNeung Asan Hospital
state: Gangwon-do
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University ANAM Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Jungyo Gwon
role: PRINCIPAL_INVESTIGATOR
References: