A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.

Official Title
-----------------
A Randomized, Dose-controlled, Open-label, Parallel, 2-treatment Group, Single Center, Pilot Study to Evaluate the Effectiveness of Sarpogrelate on Blood Hyperviscosity in the Patients With Peripheral Arterial Disease

Conditions
-----------------
Peripheral Artery Disease, PAD

Intervention / Treatment
-----------------
* Drug: Anplag Tab. 100mg bid
* Drug: Anplag Tab. 100mg tid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with PAD* (*Criteria for diagnosis of PAD: diagnosed with Burger's disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with ischemic symptoms such as ulcers, pain, cold sensation, etc.) tODI < 3 at randomization Aged ≥ 19 years Written informed consent Exclusion Criteria: Patients requiring acute or two or more antiplatelet agents Patients requiring anticoagulant therapy Patients requiring surgical procedure due to vascular occlusion Patients whose results are confirmed at the screening as follows: hemoglobin (Hb) test value: male < 13 g/dL, female < 12 g/dL platelet count < 60,000/µL severe renal disease (eGFR < 30 mL/min/1.73 m2) Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months Contraindications stated in the SPC of sarpogrelate Patients who are pregnant or planning to become pregnant Those participating in other clinical trials with administration of investigational products at the screening Those who are deemed to be ineligible to participate in the trial by investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anplag Tab. 100mg bid<br>sarpogrelate hydrochloride 100mg bid for 24 weeks | Drug: Anplag Tab. 100mg bid<br>* sarpogrelate hydrochloride 100mg bid for 24 weeks<br>* Other names: Sarpogrelate 200mg;|
| Experimental: Anplag Tab. 100mg tid<br>sarpogrelate hydrochloride 100mg tid for 24 weeks | Drug: Anplag Tab. 100mg tid<br>* sarpogrelate hydrochloride 100mg tid for 24 weeks<br>* Other names: Sarpogrelate 300mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 24 in tissue oxygen delivery index (tODI) |  | baseline, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 12 in tODI |  | baseline, week 12 | 
| Proportion of subjects with tODI elevated by 20% or more |  | baseline, week 12, week 24 | 
| Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36) |  | baseline, week 24 |