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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease, PAD
• Intervention / Treatment: Drug: Anplag Tab. 100mg bid; Drug: Anplag Tab. 100mg tid

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggido
    • Uijeongbu, Gyeonggido, Korea, Republic of
      • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anplag Tab. 100mg bid; sarpogrelate hydrochloride 100mg bid for 24 weeks	Drug: Anplag Tab. 100mg bid; sarpogrelate hydrochloride 100mg bid for 24 weeks; Other Names: Sarpogrelate 200mg
Experimental: Anplag Tab. 100mg tid; sarpogrelate hydrochloride 100mg tid for 24 weeks	Drug: Anplag Tab. 100mg tid; sarpogrelate hydrochloride 100mg tid for 24 weeks; Other Names: Sarpogrelate 300mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): December 26, 2019
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Hematologic Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Thrombophilia; 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: YMC036

Drug and device information, study documents

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