A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03509922

Enrollment

Registered

2018-04-26

Start date

2018-10-11

Completion date

2020-03-05

Last updated

2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease, PAD

Brief summary

This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.

Interventions

DRUGAnplag Tab. 100mg bid

sarpogrelate hydrochloride 100mg bid for 24 weeks

DRUGAnplag Tab. 100mg tid

sarpogrelate hydrochloride 100mg tid for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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.) 2. tODI \< 3 at randomization 3. Aged ≥ 19 years 4. Written informed consent

Exclusion criteria

1. Patients requiring acute or two or more antiplatelet agents 2. Patients requiring anticoagulant therapy 3. Patients requiring surgical procedure due to vascular occlusion 4. 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) 5. 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 6. Contraindications stated in the SPC of sarpogrelate 7. Patients who are pregnant or planning to become pregnant 8. Those participating in other clinical trials with administration of investigational products at the screening 9. Those who are deemed to be ineligible to participate in the trial by investigator

Design outcomes

Primary

Measure	Time frame
Change from baseline to week 24 in tissue oxygen delivery index (tODI)	baseline, week 24

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026