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A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

Primary Purpose

Peripheral Artery Disease, PAD

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Anplag Tab. 100mg bid

Anplag Tab. 100mg tid

About this trial

This is an interventional treatment trial for Peripheral Artery Disease, PAD

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Anplag Tab. 100mg bid

Anplag Tab. 100mg tid

Arm Description

sarpogrelate hydrochloride 100mg bid for 24 weeks

sarpogrelate hydrochloride 100mg tid for 24 weeks

Outcomes

Primary Outcome Measures

Change from baseline to week 24 in tissue oxygen delivery index (tODI)

Secondary Outcome Measures

Change from baseline to week 12 in tODI

Proportion of subjects with tODI elevated by 20% or more

Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)

Full Information

NCT ID

NCT03509922

First Posted

April 17, 2018

Last Updated

June 21, 2020

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03509922

Brief Title

A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

October 11, 2018 (Actual)

Primary Completion Date

December 26, 2019 (Actual)

Study Completion Date

March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease, PAD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anplag Tab. 100mg bid

Arm Type

Experimental

Arm Description

sarpogrelate hydrochloride 100mg bid for 24 weeks

Arm Title

Anplag Tab. 100mg tid

Arm Type

Experimental

Arm Description

sarpogrelate hydrochloride 100mg tid for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Anplag Tab. 100mg bid

Other Intervention Name(s)

Sarpogrelate 200mg

Intervention Description

sarpogrelate hydrochloride 100mg bid for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Anplag Tab. 100mg tid

Other Intervention Name(s)

Sarpogrelate 300mg

Intervention Description

sarpogrelate hydrochloride 100mg tid for 24 weeks

Primary Outcome Measure Information:

Title

Change from baseline to week 24 in tissue oxygen delivery index (tODI)

Time Frame

baseline, week 24

Secondary Outcome Measure Information:

Title

Change from baseline to week 12 in tODI

Time Frame

baseline, week 12

Title

Proportion of subjects with tODI elevated by 20% or more

Time Frame

baseline, week 12, week 24

Title

Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)

Time Frame

baseline, week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Uijeongbu

State/Province

Gyeonggido

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

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